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Shingles Vaccines

Shingles (Herpes Zoster) Vaccines 2025

Herpes Zoster, also known as shingles, is a vaccine-preventable disease caused by the varicella-zoster virus (VZV), which also causes chickenpox, according to the U.S. Centers for Disease Control and Prevention (CDC). The U.S. Food and Drug Administration (FDA) approved shingles vaccines for use according to the updated 2025 schedules. The European Medicines Agency (EMA) approves various shingles vaccines in over 30 countries. As of 2025, the shingles vaccination market exceeds $2 billion in annual revenue.

Shingles Vaccines Approved

Shingrix—GSK's Shingrix is a non-live, adjuvanted recombinant shingles vaccine (zoster) containing the varicella-zoster virus glycoprotein E antigen and the AS01B adjuvant system, a proprietary adjuvant containing QS-21 and MPL with liposomes.

Zostavax is Merck's live, attenuated varicella-zoster virus (a weakened form of the chickenpox virus) vaccine. According to the U.S. CDC, the zoster vaccine can be administered concurrently with all other live and inactivated vaccines, including those routinely recommended for people 60 or older.

SK bioscience's SKYZoster™ is a live varicella-zoster virus vaccine that attenuates the virus. SKYZoster was approved in South Korea by the Ministry of Food and Drug Safety in September 2017.

SINOVAC's live attenuated varicella vaccine, a WHO-prequalified Chinese varicella vaccine, was successfully delivered to the Republic of Türkiye in 2023 and is registered in Lebanon and Kenya.

Shingles Vaccine Candidates 2025

Curevo Vaccine's Amezosvatein (CRV-101) is an adjuvanted subunit shingles vaccine candidate designed to maximize cellular-mediated immunity (CMI) protection by combining the gE protein antigen with our proprietary adjuvant. On January 7, 2024, Curevo announced positive data from a Phase 2 trial of Amezosvatein, head-to-head versus Shingrix, in participants aged 50 and older. There were zero confirmed cases of herpes zoster (shingles) among participants in the amezosvatein arm. On October 16, 2024, the Company announced that Amezosvatein met all primary endpoints in the randomized, active-controlled, and observer-blind Phase 2 trial. On January 13, 2025, the Company announced positive updated immunogenicity and safety data from its 876-patient Phase 2 trial of amezosvatein (CRV-101) compared to Shingrix in participants aged 50 years and older. Based upon these results, Curevo will advance amezosvatein into global Phase 3 trials in 2025. On March 17, 2025, Curevo Vaccine announced the closing of a $110 million Series B round to advance the development of amezosvatein.

BioNTech SE initiated a randomized, controlled, dose-selection Phase 1/2 clinical trial of BNT167 in February 2023. The trial evaluates the safety, tolerability, and immunogenicity of mRNA vaccine candidates against shingles.

Jiangsu Recbio Technology Co., Ltd. announced on December 29, 2023, that REC610 is equipped with a novel adjuvant BFA01 independently developed by the Company, which can promote the production of high levels of VZV glycoprotein E (gE)-specific CD4+T cells and antibodies. On December 19, 2022, it received approval from the Philippines FDA to conduct a randomized, observer-blinded, phase I clinical trial. The Interim Analysis results published on December 29, 2023, showed that REC610 demonstrated an overall favorable safety and tolerability profile in healthy participants aged 40 and above after two vaccination doses. REC610 induced strong gE-specific humoral and cellular immune responses, evident after the first vaccination and peaked 30 days after the second vaccination.

Immorna announced on January 9, 2023, that the U.S. FDA cleared its investigational new drug application to conduct a Phase 1 multi-center study of JCXH-105, a self-replicating RNA vaccine against Shingles. Additionally, on May 30, 2023, the Company announced that the first subject had been dosed in its First-In-Human (FIH) Phase 1 multi-center study of JCXH-105.

Dynavax's Z-1018 is an investigational vaccine candidate being developed to prevent shingles in adults aged 50 and older. In the fourth quarter of 2024, the Company completed enrollment in the phase 1/2 trial, and Dynavax anticipates reporting top-line immunogenicity and safety data in the third quarter of 2025.

Shingles Vaccination and Dementia

On April 23, 2025, a study published in JAMA found evidence that herpes zoster vaccination reduces the risk of dementia, a finding more likely to be causal than the associations reported in existing correlational evidence. On April 2, 2025, Nature published a study - A natural experiment on the effect of herpes zoster vaccination on dementia - that provides evidence of a dementia-preventing or dementia-delaying effect from zoster vaccination that is less vulnerable to confounding and bias than the existing associational evidence. The journal BMC Public Health published results from a study on October 2, 2023. The study concluded that the zoster vaccine for the prevention of shingles/herpes zoster and the influenza vaccine to prevent influenza were associated with a diminished risk of dementia, with the zoster association appearing more pronounced. A non-peer-reviewed study published on May 25, 2023, reported that shingles vaccinations were associated with a 19.9% lower risk of dementia.

Shingles Vaccination and Cardiovascular Events

A study published in the European Heart Journal in May 2025 shows a 23% lower risk of cardiovascular events in recipients of the shingles vaccine in the 8 years following vaccination. These findings suggest that live zoster vaccination may be beneficial for reducing the burden of cardiovascular disease in the general population.

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Robert Carlson, MD

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Shingles Vaccines

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Shingles

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Thursday, December 11, 2025 - 16:35

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Lyme Disease Vaccines

Lyme Disease Vaccine Candidates

Lyme disease vaccine research includes early-stage discovery and novel vaccine formulations, including tick saliva-based approaches. In addition, the U.S. National Institutes of Health (NIH) published a Strategic Plan for Tickborne Disease Research that prioritizes vaccines needed to prevent diseases. As of March 2025, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the United Kingdom have not approved a preventive Lyme disease vaccine. The only human Lyme disease vaccine marketed in the U.S. was LYMERix®, which was discontinued in 2002.

According to IMARC, the Lyme disease market was worth $594 million in 2023. Over the next decade, it is expected to exceed $1 billion by 2034, exhibiting a growth rate of 6.45%.

Lyme Disease Vaccine Candidates 2025

VLA15, a multivalent Lyme Disease vaccine candidate produced by Pfizer Inc. and Valneva SE, targets Borrelia's outer surface protein A and conducts late-stage clinical trials.

Moderna Inc. is advancing a seven-valent approach with two Lyme disease vaccine candidates that will be developed in parallel. mRNA-1982 is designed to elicit antibodies specific for Borrelia burgdorferi, which causes almost all Lyme disease in the U.S. mRNA-1975 is designed to elicit antibodies specific for the four major Borrelia species causing disease in the U.S. and Europe.

TP-05 is a novel investigative oral therapeutic that could potentially prevent Lyme disease. It is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-CI channels.

The National School of Tropical Medicine at Baylor College of Medicine and Texas Children's Hospital's Center for Vaccine Development received an $860,000 grant from the U.S. Department of Defense to develop a recombinant protein vaccine for Lyme disease. The Congressional Director of Medical Research Programs supports this work through the DoD Tick-borne Disease Research Program. W81XWH-20-1-0913.

Penn Medicine's Lyme disease vaccine candidate uses mRNA-LNP platform technology pioneered at Penn. After a single immunization, the OspA mRNA-LNP vaccine induced superior humoral and cell-mediated immune responses in mice. These potent immune responses resulted in protection against bacterial infection.

CyanVac's intranasal parainfluenza virus 5 (PIV5)-based vaccine for Lyme Disease was found in a study to induce protection against a multi-strain Borrelia burgdorferi tick challenge in mice. The Lyme disease project was a collaboration between CyanVac and Immuno Technologies, Inc. and was supported by the National Institute of Allergy and Infectious Disease.

Lyme Disease Diagnostics

Many tick-borne infections are misdiagnosed because their nonspecific symptoms mirror other illnesses. In addition, several Borrelia sub-species and strains exist, and researchers continue to discover new species.

Lyme Disease Overview

According to the U.S. NIH, Borreliosis is an infectious disease caused by spiral-shaped bacteria known as Borreliae, often carried by ticks. The species of Borreliae known to cause disease in humans are split into the following two groups: B. burgdorferi sensu lato, which causes Lyme disease, and Relapsing Fever Borrelia, which causes Tick-borne Relapsing Fever.

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Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

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Lyme Disease Vaccines

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Vaccine

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Lyme Disease

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Monday, March 3, 2025 - 06:10

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United States of America

Alzheimer’s Disease Vaccines

Alzheimer's Disease Vaccine and Monoclonal Antibody 2024

As of June 14, 2024, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japan, and the United Kingdom's NHS have not authorized preventive Alzheimer's disease (AD) vaccines or approved therapeutics for bipolar disorder (BD), major depressive disorder (MDD) and post-traumatic stress disorder (PTSD). In the United States, the CDC says about 4% of people over 65 years of age have Dementia. Recently, monoclonal antibody intravenous infusion therapies (Leqembi® and Aduhelm®) have been approved in the U.S. and Japan to treat, not prevent, early AD, a degenerative brain disease.

Alzheimer's Vaccine Candidates 2024

AADvac1 is a therapeutic vaccine candidate for Alzheimer's disease that targets misfolded tau protein, a common denominator of neurofibrillary pathology.

ACI-35.030 is a first-in-class AD vaccine candidate designed to generate a specific antibody response against pTau proteins in the brain. AC Immune is collaborating with Janssen Pharmaceuticals, Inc. Recent results show that ACI-35.030 treatment rapidly leads to the strong and durable induction of antibodies specific for pathological forms of Tau, such as pTau and its aggregated form, ePHF. In addition, the ACI-35.030-induced antibody response was sustained and could be periodically boosted over 72 weeks.

Alzamend Neuro, Inc.'s AL001 novel lithium-delivery system can potentially deliver the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. AL001 is designed to distribute lithium in the brain, resulting in lower exposure to other body organs and an improved safety profile compared to currently marketed lithium salts. Alzamend Neuro announced in October 2023 the receipt of a "Study May Proceed" letter from the U.S. FDA for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1. On March 22, 2023, the Company announced the completion of the clinical portion of its Phase IIA multiple ascending dose study. On November 20, 2023, the Company announced a receipt of a "Study May Proceed" letter from the FDA for the initiation of study AL001-MDD01, a Phase IIA clinical study of AL001 for treating patients with MDD. On December 11, 2023, the Company received a "Study May Proceed" letter from the FDA for the initiation of study AL001-PTSD01, a Phase IIA clinical study of AL001 for treating patients with PTSD. On May 9, 2024, the Company announced a stock offering for $25,000,000.

Alzinova AB's ALZ101 is an active, therapeutic oligomer-specific vaccine candidate that stimulates the production of antibodies against the toxic Aβ oligomers. The first-in-human Phase 1b study in patients with early AD was initiated in 2021. Alzamend is also pursuing AL001 for the treatment of bipolar disorder and PTSD. Topline data for the analysis is anticipated in the second half of 2023. In addition, the Company partnered with the Miller School of Medicine and the Interdisciplinary Stem Cell Institute at the University of Miami in Florida for its Phase I/IIA clinical trial of ALZN002.

Araclon Biotech's ABvac40 is an active vaccine against the Aβ40 peptide for treating patients with early-stage Alzheimer's disease. On October 25, 2023, the Company reported a phase 2 trial met primary endpoints, confirming the vaccine's safety, tolerability, and robust immune response against the Aβ40 peptide in early-stage Alzheimer's patients. ABvac40 treatment slowed disease progression up to 38% compared with placebo as measured by the Mini-Mental State Examination score.

Alzheimer's Monoclonal Antibody Treatments

Aduhelm™ is an amyloid beta-directed antibody injection of 100 mg/mL for intravenous use indicated to treat AD and was approved by the FDA on July 8, 2021. The FDA issued approval to Biogen and Eisai Co., Ltd.

Leqembi™ gained U.S. FDA traditional approval for treating AD l on July 6, 2023. The approval of Leqembi (BAN2401, lecanemab-irmb) was granted to Eisai R&D Management Co., Ltd. On September 25, 2023, Japan issued a similar authorization, as did China on January 9, 2024.

Eli Lilly's donanemab (Kisunla™) was approved in July 2024 for a broad population of people diagnosed with mild cognitive impairment due to Alzheimer’s. The total cost of Kisunla will vary by patient based on when they complete treatment. A JAMA Original Investigation published positive study results in 2023.

Gantenerumab is a fully human IgG1 antibody that binds with subnanomolar affinity to a conformational epitope on Aβ fibrils. It encompasses both N-terminal and central amino acids of Aβ. A November 2023 study found that Gantenerumab led to a lower amyloid plaque burden among persons with early AD than placebo at 116 weeks. Still, it was not associated with slower clinical decline. (GRADUATE I and II; NCT03444870 and NCT03443973. In 2021, Gantenerumab was granted U.S. FDA Breakthrough Therapy Designation in Alzheimer's Disease.

ACI-24.060 is an amyloid-beta (Abeta) antibody produced by AC Immune SA and derived from the Company's SupraAntigen® platform. The FDA awarded Fast Track destination on June 27, 2023. On May 13, 2024, AC Immune and Takeda announced a partnership.

ADvantage Therapeutics, Inc. announced that the UK's MHRA had granted AD04™ an Innovation Passport for treating AD under the Innovative Licensing and Access Pathway on April 5, 2023. Authorities in Poland, Bulgaria, and Slovakia approved its Clinical Trial Application on June 20, 2023, to conduct a clinical trial with AD04. The Company believes AD04™ may function as an immunomodulator, stimulating and/or regulating the immune system to reduce AD pathology. Rather than being limited to a specific aspect of AD pathology, such as amyloid beta or tau, AD04™ may restore the expression of genes in lipid metabolism, improve phagocytosis, and reduce inflammation. On November 27, 2023, the Company announced the first patient enrolled in AD04's European Phase 2b clinical trial.

ProMIS therapeutic product candidate PMN310 is a monoclonal therapeutic antibody designed to treat AD, consisting of an AβO conformational peptide epitope conjugated to KLH as a carrier protein to provide T cell help, elicited robust and sustained antibody responses with either alum or QS-21 as the adjuvants.

UB-311 is a synthetic, peptide-based active immunotherapy candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent Alzheimer's disease. Phase 1, Phase 2a, and Phase 2a long-term extension trials have shown UB-311 to be well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo and no cases of amyloid-related imaging abnormalities-edema in the Phase 2a trial. It was granted U.S. FDA Fast Track status.

Alzheimer's Treatments

Eli Lilly and Company presented an interim analysis from a phase 1 study of LY3372993 on March 31, 2023. Remternetug (LY3372993) is an IgG1 monoclonal antibody directed at the pyroglutamate modification of the third amino acid of the amyloid-beta peptide that is present only in brain amyloid plaques. This antibody demonstrated rapid and robust amyloid plaque reduction in participants with AD. The safety, tolerability, and pharmacokinetic/pharmacodynamic data support the ongoing Phase 3 trial (NCT05463731)

Alzamend Neuro, Inc.'s AL001 is a patented ionic cocrystal technology that delivers a therapeutic combination of lithium, proline, and salicylate to treat Alzheimer's and other neurodegenerative diseases and psychiatric disorders. ALZN002 immunotherapy is intended to treat patients diagnosed with Alzheimer's by inducing their antibodies. These are targeted to remove the Aβ1‑42 protein, reducing the deposition of amyloid plaque in the brain and thereby reducing the progression of disease-associated clinical signs and symptoms. The Company partnered with Biorasi as its contract research organization.

Prothena Corporation's PRX012 is a next-generation, high-binding potency antibody designed to enable subcutaneous dosing on a patient-friendly, convenient administration schedule, potentially providing greater accessibility for AD patients and caregivers. Accordingly, the U.S. FDA granted Fast Track Designation on April 26, 2022.

Synaptogenix, Inc.'s Bryostatin-1 is targeting Alzheimer's disease. The paper "Advanced Alzheimer's Disease Patients Show Safe, Significant, and Persistent Benefit in 6-Month Bryostatin Trial" concluded that the Bryostatin-treated MMSE 10-14 patients showed no significant cognitive decline throughout the 10-month trial. In contrast, the placebo patients declined by -12.8 SIB points.

BCG Vaccination and Dementia

An Original Investigation led by investigators at Massachusetts General Hospital and Brigham and Women's Hospital was published by The JAMA Network on May 19, 2023, concluding that BCG vaccination was associated with a lower rate and risk of Alzheimer's disease and related Dementia. In a risks analysis, the BCG vaccine was associated with a lower risk of Alzheimer's disease and related dementias (ADRD) (5-year risk difference, −0.011; 95% CI, −0.019 to −0.003) and a decreased risk of death in patients without an earlier diagnosis of ADRD (5-year risk difference, −0.056; 95% CI, −0.075 to −0.037).

Alzheimer's Testing

Researchers at Karolinska Institutet announced on April 12, 2023, that a type of sugar molecule in the blood is associated with the level of Tau. This protein plays a critical role in the development of severe Dementia. Therefore, bisecting N-acetylglucosamine and Tau are valuable blood biomarkers for predicting AD. The U.S. FDA permitted marketing on May 4, 2022, for Fujirebio Diagnostics, Inc. Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test intended to be used in adult patients aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.

On December 27, 2022, a new study, Brain-derived Tau: a novel blood-based biomarker for Alzheimer's disease-type neurodegeneration, presented a novel blood test that assessed brain-derived Tau-detected Alzheimer' s-related neurodegeneration and differentiated Alzheimer's from other neurodegenerative diseases. Furthermore, this innovative test outperformed total Tau and, unlike neurofilament light, showed specificity to Alzheimer's disease-type neurodegeneration. Thus, brain-derived Tau demonstrates the potential to complete the AT(N) scheme in blood and will be used in evaluating.

Note: This webpage aggregates and edits content and manually curates it for mobile readers. Healthcare providers fact-check all content.

0 min read

Reviewer:

Robert Carlson, MD

Danielle Reiter RN

Holly Lutmer PharmD

Vaccine:

Alzheimer’s Disease Vaccines

Drug Class:

Vaccine

Lab Test:

CDC

Condition:

Alzheimer’s Disease

Last Reviewed:

Monday, July 1, 2024 - 07:30

Status:

Candidate

Countries:

U.S. - mAb treatment

Zika Outbreaks

Zika Outbreaks December 2025

Zika virus disease (ZIKV) was first recognized in Uganda in 1947, with the initial human infection confirmed in 1952. In 2016, the World Health Organization (WHO) declared the Zika virus epidemic a public health emergency of international concern. Since then, Zika outbreaks have been reported in tropical Africa, Southeast Asia, the Pacific Islands, in the Americas, and continue to occur in 92 countries and territories globally. The WHO published a Global Strategic Preparedness, Readiness, and Response Plan for Aedes-borne arboviruses on January 20, 2025. Studies predict that because of virus-carrying mosquitoes expanding into new geographic areas, about 1.3 billion people could be impacted by Zika by 2050.

As of 2025, the U.S. Centers for Disease Control and Prevention (CDC) Yellow Book states that international travelers with suspected Zika infection should be tested with real-time polymerase chain reaction or an NS1 antigen test. In 2025, public health and commercial lab testing services can detect Zika infections in people.

Zika in the United States

As of 2025, the Pan American Health Organization (PAHO) reported travel-related Zika cases in the United States. The Hawaiʻi Department of Health announced on May 27, 2025, that it is investigating two travel-related Zika cases, and Puerto Rico has been categorized as having a risk of Zika transmission for several years. As of December 31, 2024, the U.S. CDC reported 19 non-congenital Zika cases among U.S. residents (1 imported case in Texas). In 2023, the CDC reported five non-congenital cases among U.S. residents and 27 in U.S. territories. The CDC says Zika-spreading mosquitoes are found throughout Puerto Rico, where the Department of Health says 16 cases were reported in 2024.

Zika Outbreaks in The Americas

The PAHO has confirmed local transmission of the Zika virus in 52 countries and territories in the Americas since 2015. As of December 2025, over 25,800 Zika cases and four related fatalities were reported in the Americas this year. The PAHO reported 42,127 ZIka cases and two associated fatalities in the Americas in 2024, with the highest proportion of Zika cases reported in Argentina, Brazil, Bolivia, Colombia, and Costa Rica. The PAHO reported over 37,659 Zika cases in the Americas in 2023. In 2021, the U.S. CDC removed its Level 2—Practice Enhanced Precautions notice regarding Argentina's Zika outbreak.

Zika in Europe

The European Centre for Disease Prevention and Control (ECDC) says the Zika virus is not endemic in mainland Europe. In August 2025, France reported four travel-related Zika cases. In November 2024, Italy reported 7 imported Zika cases this year. On September 11, 2024, France reported five imported cases of Zika in 3 departments colonized by Aedes albopictus. In 2022, the European CDC reported that 31,453 Zika patients were confirmed in 13 of 52 countries and territories. In addition, the WHO reported in 2019 that French authorities confirmed an autochthonous Zika virus case in Hyeres, Var department.

Zika United Kingdom

Zika virus disease cases also decreased to 4 cases in the first half of 2025. Zika cases increased to 16 in England, Wales, and Northern Ireland in 2024, up from 8 in 2023. Thailand (5 cases) and Singapore (2) were the most frequently reported travel countries. The UK Health Security Agency (UKHSA) issued a warning on March 21, 2024, concerning Zika outbreaks. Travel-related Zika cases in the UK peaked in 2016 with 725 cases.

Zika Virus Infection Impact

According to the WHO, there is scientific consensus that the Zika virus is transmitted to people by mosquitoes of the genus Aedes. Since 2013, 31 countries and territories have reported cases of congenital microcephaly and other central nervous system malformations associated with Zika virus infection. The WHO reports that Zika virus lineages, the African lineage and the Asian lineage, have recently spread in the Pacific and the Americas. Zika infections can cause microcephaly, Guillain-Barré syndrome (GBS), and other central nervous system malformations. Although the Zika outbreak in southern Brazil has slowed in recent years, live births with microcephaly continue to be reported.

The U.S. CDC published Research, Volume 30, Number 2—February 2024: a temporal phylogenetic analysis revealed limited within-host diversity among most ZIKV-persistent-infected associated samples. The researchers detected unusual viral diversity, uncovering the existence of divergent genomes within the same patient. During pregnancy, healthcare providers can monitor the fetus for signs of congenital Zika virus infection.

An Original Investigation published by JAMA Public Health on January 23, 2025, found that children younger than 5 years born with congenital Zika syndrome (CZS) had a 13.10-fold higher hazard of death compared with those without CZS. The cause-specific mortality hazard ratios were 30.28 for respiratory diseases, 28.26 for infectious and parasitic diseases, and 57.11 for nervous system diseases. Research published in Communications Biology and the Liverpool School of Tropical Medicine on January 20, 2025, reported that the Zika virus hijacks the skin of its human host to send chemical signals that lure more mosquitoes to infect and spread the disease further.

Congenital Zika Syndrome

A population-based study of mortality rates among children younger than 5 years old in Brazil, published in JAMA Network Open in January 2025, showed that children with congenital Zika syndrome (CZS) had a 13-fold higher risk of death compared with those without CZS.

The 2015–2016 ZIKV outbreak in the Region of the Americas revealed the ability of ZIKV from the Asian lineage to cause congenital disabilities, generically called CZS, which caused severe congenital disabilities of the brain and eyes, including severe microcephaly. A study published in Pediatrics in January 2025 concluded that children exposed to ZIKV in utero, even without CZS, demonstrate a greater risk for neurodevelopmental delay in early childhood, with the timing of maternal infection being a significant predictive risk factor. The International Journal of Infectious Diseases published a study in 2025 showing that children with CZS are more likely to experience frequent hospitalizations in early childhood. Scientists have reported that ZIKV RNA is detectable in the semen of infected men for months and is found in newborn children.

Zika Vaccines

As of 2025, no approved Zika vaccine exists; however, vaccine candidates are currently being tested in clinical trials.

6 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Wednesday, December 3, 2025 - 09:10

Description:

Zika outbreaks in 2025 are caused by mosquitoes transmitting virus to people that cause microcephaly in children.

Vaccine:

Zika Vaccine VLA1601

mRNA-1608 Herpes Vaccine

mRNA-1608 Herpes Vaccine Clinical Trials, Dosage, Indication, News, Side Effects

Moderna Inc.'s herpes simplex virus (HSV) vaccine candidate, mRNA-1608, is a Messenger RNA (mRNA) vaccine targeting HSV-2 disease. On February 18, 2022, Moderna Inc. stated that it expects an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, Moderna aims to induce a strong antibody response that combines neutralizing and effector functionality with cell-mediated immunity. In clinical trials, a prophylactic genital herpes vaccine should prevent HSV-1 and HSV-2 genital lesions and infection of the dorsal root ganglia, the site of latency. Additionally, vaccine immunity should be durable for decades, possibly without the need for booster doses. While these efficacy goals have been elusive from previous herpes vaccine candidates, new efforts with nucleoside-modified mRNA-lipid nanoparticle vaccines show great promise.

Moderna is developing mRNA-1608 to reduce the burden of HSV lesions, leveraging mRNA technology that offers potential advantages in efficacy, development speed, and production scalability and reliability. This may position our company as a leader in preparing for and responding to infectious disease threats that pose a significant risk to millions of people worldwide. To further characterize Moderna's IM vaccines, biodistribution studies were conducted to demonstrate the location of mRNA in the body after injection. Studies indicate that injected mRNA remains predominantly at the injection site and nearby draining lymph nodes. Furthermore, consistent with its transient nature, mRNA is undetectable in the body five days after injection, with minimal mRNA detectable after only three days.

A Phase 1 clinical study of mRNA-1608 in Healthy Adults Aged 18 to 55 with recurrent genital herpes caused by HSV-2 began recruiting participants on September 6, 2023. On March 27, 2024, Moderna confirmed the first-in-human, fully enrolled Phase 1/2 clinical trial (NCT06033261) of mRNA-1608, which includes three hundred participants with a history of recurrent genital herpes, randomly assigned in a 1:1:1:1 ratio to receive mRNA-1608 at one of the three dose levels or control (BEXSERO) administered as two doses at 0 and 2 months (Day 1 and Day 57). This study (mRNA-1608-P101) aims to generate safety and immunogenicity data and establish a proof of concept of the clinical benefit of the mRNA-1608 vaccine candidate. On May 2, 2024, Moderna announced that the Phase 1/2 study of mRNA-1608 was fully enrolled. The actual study Start Date was September 6, 2023; the Last update was September 24, 2024; and the Estimated Primary Completion Date is April 11, 2025.

As of 2025, the U.S. Food and Drug Administration (FDA), the European Medicines Agency, and the U.K. have not approved a vaccine for the prevention of herpes. An analysis published in December 2024 found the global economic cost of herpes infections to be $35 billion annually. In 2025, people can order a herpes test commercially from laboratories. As of April 2025, clinical trials for herpes are accepting new participants.

Massachusetts-based Moderna, Inc. (NASDAQ: MRNA), a biotechnology company, is pioneering the development of messenger RNA therapeutics and vaccines. Moderna is developing vaccine candidates against latent viruses, including cytomegalovirus, Epstein-Barr virus, Human immunodeficiency virus, herpes simplex virus (HSV), and varicella-zoster virus (VZV).

mRNA-1608 Herpes Vaccine Indication

HSV has developed numerous defense mechanisms to evade innate and adaptive immunity systems. In the U.S., approximately 18.6 million adults ages 18 to 49 live with HSV-2, known as genital herpes. The U.S. CDC categorizes herpes simplex viruses into two types: HSV-1 primarily infects the mouth, face, and genital area, while HSV-2 primarily infects the genital region. Both herpes viruses establish lifelong latent infections within sensory neurons from which they can reactivate and re-infect the skin.

mRNA-1608 Herpes Vaccine Clinical Trial Sites in Texas

In Texas, these sites are conducting clinical trials:

Cedar Park, Texas, United States, 78613

Velocity Clinical Research, Austin

Fort Worth, Texas, United States, 76107

Helios CR, Inc., Fort Worth

Houston, Texas, United States, 77081

DM Clinical Research

San Antonio, Texas, United States, 78215

Sun Research Institute

Tomball, Texas, United States, 77064

DM Clinical Research

mRNA-1608 Herpes Vaccine Candidate News

December 11, 2024 - An estimated 846 million people aged between 15 and 49 are living with genital herpes infections.

May 4, 2022 - Moderna confirmed that preclinical studies are underway for the mRNA-1608 vaccine candidate.

April 2022 - The NIH published a study discussing the trivalent mRNA-lipid nanoparticle approach for a prophylactic genital herpes vaccine, as well as its ability to induce higher titers of neutralizing antibodies and more durable CD4+ T follicular helper cell and memory B cell responses than protein-adjuvanted vaccines.

March 2022: Moderna Inc. confirmed that preclinical studies are underway for VZV (mRNA-1468) and HSV (mRNA-1608) vaccine candidates. Both are members of the Herpesviridae family, which establishes life-long latent infections.

February 18, 2022 - Moderna, Inc. announced an expansion of its mRNA vaccine pipeline with three new development programs. "We are pleased to announce these new development programs, which reflect the continued productivity of our platform and the potential of our mRNA technology to impact the lives of hundreds of millions of people," said Stéphane Bancel, Chief Executive Officer of Moderna.

December 22, 2021 - Translational Research published a Review article: An mRNA vaccine to prevent genital herpes.

July 27, 2020 - PLOS published a study concluding that the HSV-2 trivalent mRNA vaccine is a promising candidate for clinical trials to prevent genital herpes caused by HSV-1 and HSV-2.

mRNA-1608 Herpes Vaccine Candidate Clinical Trials

As of 2025, Moderna publishes clinical trial updates at this web link. According to GlobalData, Phase II drugs for Genital Herpes have a 30% success rate in transitioning to Phase III, serving as a benchmark for progression.

A Phase 1/2, Randomized, Observer-Blind, Controlled, Dose-Ranging Study of mRNA-1608, an HSV-2 Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 —Last updated September 24, 2024, has a completion date of 2025-04-11. This study aims to generate safety and immunogenicity data and establish a proof-of-concept of the clinical benefit of the mRNA-1608 vaccine candidate.

0 min read

Manufacturer:

Moderna

Reviewer:

Robert Carlson, MD

Vaccine:

mRNA-1608 Herpes Vaccine

VIS:

PDF

Availability:

N/A

Generic:

mRNA-1608

Clinical Trial:

https://trials.modernatx.com/search-results/?PageIndex=0

Drug Class:

mRNA Vaccine

Clinical Trial Phase I:

mRNA-1608-P101

Condition:

Herpes

Last Reviewed:

Friday, December 12, 2025 - 09:55

Status:

Candidate

Manufacturer Country ID:

FDA First In Class:

Yes

Location tags:

United States of America

HIV Vaccines

HIV Vaccines Clinical Trials, Dosage, Indication, Side Effects

Human Immunodeficiency Virus (HIV) vaccine development accelerated in 2024, with candidates utilizing innovative technologies such as mRNA. Novotech's HIV Global, Clinical Trial Landscape report, revealed the biopharma industry has initiated over 1,000 HIV clinical trials worldwide since 2018. Developing HIV vaccines requires various clinical trials: phase 1, phase 2, phase 3, and phase 4; each development step is essential. The U.S. National Institutes of Health (NIH) published an article: Progress toward an HIV vaccine. The development of a preventive vaccine against HIV represents the best solution for controlling and eradicating the HIV pandemic, says the Vaccine Research Institute.

As of August 2024, the U.S. Food and Drug Administration (FDA), Brazil, Japan's National Institute of Infectious Diseases, the European Medicines Agency (EMA), and the United Kingdom had not approved an HIV prevention vaccine. On February 24, 2023, HIV.gov spoke with Dr. Dieffenbach, who noted that while there won't be an HIV vaccine in the near term, he encouraged anyone interested in learning about current HIV vaccine clinical trials to visit the HVTN website.

HIV Vaccine Candidates 2024

Following the discovery of HIV as a causative agent of AIDS, multiple HIV vaccine clinical trials have been conducted globally over the past 35 years. The use of nanotechnology in the design and improvement of HIV vaccines has recently advanced.

Moderna Inc. is advancing three Phase I clinical trials of HIV vaccines with partners (mRNA-1644/IAVI G002; mRNA-1644/IAVI G003; mRNA-1574/NIAID). mRNA-1574 is participating in the U.S. NIH's HVTN 302 study, there are three vaccine candidates: 1) BG505 MD39.3 mRNA, 2) BG505 MD39.3 gp151 mRNA, and 3) BG505 MD39.3 gp151 CD4KO mRNA.

ViiV Healthcare and GSK are advancing in the development of various HIV treatments (VH3810109, GSK3640254) that empower the suppression of the virus to undetectable levels.

eOD-GT8 60mer (mRNA-1644) - Developed by scientific teams at IAVI and Scripps Research and delivered via Moderna's mRNA platform. Recent findings from the Phase I clinical trial IAVI G001 showed that vaccination with the HIV immunogen eOD-GT8 60mer as a recombinant protein vaccine safely induced the targeted immune responses in 97% of recipients.

Vir Biotechnology, Inc. is developing VIR-1388, an investigational novel T-cell vaccine for the prevention of HIV based on the human cytomegalovirus vector (CMV) platform. A weakened version of CMV delivers the HIV vaccine material to the immune system without causing disease in the study participants.

HOOKIPA Pharma - Arenaviral therapeutic vaccines showed in a nonhuman, preclinical setting that 2-vector therapy induces a greater immune response than single-vector therapy and significantly reduces viral load.

AELIX Therapeutics S.L. - The therapeutic HIV vaccine, HIVACAT T-cell immunogen, is a novel HIV vaccine immunogen that leads to a prolonged period without Antiretroviral Treatment and supports the use of HTI vaccine for combination cure strategies for HIV—positive results from the phase 1 clinical study AELIX-002 published in the journal Nature Medicine.

CD40.HIVRI.Env is a vaccine candidate conducting a phase 1 clinical study and was developed by the Vaccine Research Institute (ANRS and Université Paris-Est Créteil, France) with a technology whose exclusive worldwide license is held by LinKinVax. On February 22, 2023, LinkinVax announced the observed counts of CD4+ T cells targeting specifically the HIV envelope protein produced after the vaccination remained stable until Week 48.

Uvax Bio, LLC announced in December 2023 that the U.S. NIH agreed to sponsor its HIV-1 vaccine candidate in a Phase 1 clinical trial to launch in the first quarter of 2024. The two vaccines being tested are based on Uvax Bio's proprietary 1c-SApNP® technology, displaying 20 uncleaved, prefusion-optimized (UFO) HIV envelope (Env) trimers in wild-type and glycan-trimmed forms (UVAX-1197 and UVAX-1107, respectively). The first participant was dosed in a Phase 1 clinical trial in Australia evaluating UVAX-1107 and UVAX-1197 on January 30, 2024. Uvax Bio's HIV-1 vaccines are combined with CpG 1018® adjuvant and aluminum hydroxide. In addition, research (April 2023) reported a single-component, self-assembling protein nanoparticle (1c-SApNP) could display 8 or 20 native-like Env trimers as vaccine candidates.

Helocyte, Inc.'s Triplex is a universal (non-HLA-restricted) recombinant Modified Vaccinia Ankara viral vector vaccine engineered to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins linked to CMV complications in the post-transplant setting. On October 16, 2023, the Company announced that it executed an exclusive option agreement with the City of Hope for patent rights to use Triplex, a cytomegalovirus vaccine, in combination with cytomegalovirus-specific, Anti-Human Immunodeficiency Virus Chimeric Antigen Receptor (CMV/HIV-CAR) T Cells for the treatment of adults living with HIV.

ReiThera Srl, the Ragon Institute of Mass General, MIT, Harvard, and IAVI are developing a novel HIV vaccine candidate that will be composed of ReiThera's Gorilla adenoviral vector (GRAd) vector, belonging to species C adenoviruses that are considered among the most potent vaccine carriers for the induction of CD8 T-cell responses to the encoded antigens and having a low seroprevalence in humans, and HIV T-cell epitope. IAVI is the sponsor and will execute a phase I clinical trial.

CytoDyn Inc. submitted a revised HIV clinical trial protocol to the FDA on February 1, 2024. The Company believes this submission removes the current clinical hold. On February 29, 2024, the FDA withdrew the clinical hold.

PrEPVacc HIV Prevention Study

On December 6, 2023, the PrEPVacc study team announced that they were discontinuing vaccinations following an independent data safety committee review that determined there was a minimal chance these HIV vaccines could stop HIV acquisition. However, the study's oral preexposure prophylaxis (PrEP) arms continue. The PrEPVacc clinical study combines the evaluation of experimental HIV vaccines and PrEP. As of March 2023, the study tested two different formulations of daily oral PrEP to see if a new F/TAF formulation (Descovy®) is effective. This clinical trial will provide data for F/TAF among cisgender women (87% of PrEPVacc trial participants). F/TAF is approved for use in the US and UK for selected people.

HVTN HIV Vaccine Candidate Clinical Trials

The HVTN datasets for phase 1a-2 trials can be found at this link.

HVTN 502 is a phase 2b trial evaluating the MRK Ad5 HIV-1 gag/pol/nef vaccine in 3,000 men and women at high risk of HIV in North America, the Caribbean, South America, and Australia.

HVTN 505 is a phase 2b trial evaluating the DNA/rAd5 HIV-1 vaccine in 2,504 men or transgender women who have sex with men in the U.S.

HVTN 702 (Uhambo) is a phase 2b/3 trial evaluating the ALVAC-HIV + subtype C gp120/MF59 vaccine in 5,404 men and women at high risk of HIV in South Africa.

HVTN 703/HPTN 081 and HVTN 704/HPTN 085 are two parallel phase 2b trials evaluating passive infusion of the broadly neutralizing antibody VRC01 in 2,699 at-risk cisgender men and transgender persons in the Americas and Europe and 1,924 at-risk women in sub-Saharan Africa.

HIV Monoclonal Antibody

Trogarzo® (ibalizumab) is a monoclonal antibody antiretroviral therapy associated with favorable virologic outcomes used in routine care in heavily treatment-experienced people with HIV in a study posted in May 2023. Trogarzo is a long-acting, CD4-directed, post-attachment HIV-1 inhibitor.

The peer-reviewed journal Nature published a study on June 1, 20,22 that concluded two HIV-specific broadly neutralizing monoclonal antibodies, 3BNC117 and 10-1074, completely suppressed HIV for about 40 weeks in patients who participated in a U.S. government-funded phase 1 clinical trial. The findings suggest that future antibody therapies may offer effective HIV treatment for extended periods without antiretroviral therapy.

Leronlimab, a CCR5 antagonist IgG4 monoclonal antibody, is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of specific immune system cells believed to play a role in numerous disease processes, including HIV.

A small phase I clinical trial led by Massachusetts General Hospital has tested an anti-HIV strategy involving an adeno-associated viral vector-based gene delivery system that instructs cells to pump out antibodies that block HIV. The treatment was safe and well-tolerated in the trial of eight adults with HIV. In addition, all participants produced measurable amounts of anti-HIV antibodies in their blood as of April 11, 2022.

ViiV Healthcare N6LS is a broadly neutralizing antibody that works by binding to a specific site (gp120) on the surface of HIV, preventing its entry into immune system cells (CD4+ T-cells). By blocking HHIV'sentry into human CD4+ cells, the virus cannot replicate, and the HIV transmission process may be prevented.

HIV Prevention

In August 2023, the U.S. Preventive Services Task Force recommended that clinicians prescribe preexposure prophylaxis using effective antiretroviral therapy to persons at increased risk of HIV acquisition to decrease the risk of acquiring HIV.

The U.S. FDA-approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms for preexposure prevention to reduce the risk of sexually acquired HIV on December 20, 2021.

According to an editorial published in JAMA Internal Medicine, cabotegravir can be taken once every two months.

EDURANT® is a human immunodeficiency virus type 1 (HIV-1) specific, nonnucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 12 years of age and older and weighing at least 35 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.

Gilead Sciences, Inc. announced on December 22, 2022, that Sunlenca® (lenacapavir), in combination with other antiretroviral, was Approved by the U.S. FDA for the treatment of HIV-1 infection in heavily treatment-experienced adults with multi-drug resistant HIV-1 infection. Sunlenca offers a twice-yearly treatment option for adults with HIV that their current treatment regimen does not adequately control. In May 2022, the NEJM published an ORIGINAL ARTICLE: Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection.

Gilead Sciences, Inc. announced on February 22, 2023, data evaluating lenacapavir in combination with broadly neutralizing antibodies (bNAbs) teropavimab and zinlirvimab as a potential long-acting treatment regimen with twice-yearly dosing. Results from the Phase 1b clinical trial demonstrated the investigational combination was generally well tolerated with high efficacy in select virologically suppressed participants living with HIV. The combination of lenacapavir with teropavimab and zinlirvimab will advance to a Phase 2 study in 2023 in virologically suppressed people with HIV.

Gilead Sciences, Inc.'s open-label phase 1 clinical study evaluated the efficacy and safety profile of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in 33 virologically suppressed pregnant women with HIV. On December 12, 2023, the study's conclusion stated pharmacokinetic and safety data, combined with maintenance of robust virologic suppression, suggest that once-daily B/F/TAF without dose adjustment is appropriate during pregnancy.

The UB-421 SC formulation Semzuvolimab is in Phase 2 clinical trial development for HIV treatment, Last Update was Posted on February 23, 2023, with an Estimated Study Completion Date of December 31, 2025. The study protocol is entitled: Single arm Open-Label Phase 2 Trial of anti-CD4 Antibody UB-421 in Combination with Optimized Background Antiretroviral Therapy in Patients with Multi-Drug Resistant HIV-1 InfectThe NIAID/NIH sponsors this trialD/NIH. It was developed to provide a convenient delivery method compared to the IV route so patients can self-administer the medication.

Sexually Transmitted Disease Vaccines

The sexually transmitted disease vaccine summary was updated in 2024.

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Reviewer:

Robert Carlson, MD

Vaccine:

HIV Vaccines

Availability:

N/A

Clinical Trial:

https://info.trialsearch.com/search-clinical-studies/?ad_id=12&cid=c8184e623bc4457eb23d81aadab4d2fe&o=12&ps=ws10&realtime=1&s=ss3&split_id=1482&utm_campaign=22&utm_medium&utm_source=everflow&utm_term=c8184e623bc4457eb23d81aadab4d2fe

Drug Class:

vaccine

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Clinical Trial Phase I:

NIH

Clinical Trial Phase III:

Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus, Adjuvanted Clade C g

Condition:

HIV

Last Reviewed:

Saturday, August 3, 2024 - 05:45

Status:

Candidate

Countries:

U.S.

Avian Influenza Vaccines

Avian Influenza Vaccines 2025

The World Health Organization (WHO) reported in 2025 that over 1,000 human cases of influenza A have been reported globally since 2003. These cases include H5, H5N1, H5N6, and H5N8 strains of influenza A virus. In 2025, over 20 influenza A (bird flu) vaccines are available worldwide. The WHO updated recommendations for the development of new candidate vaccines for zoonotic influenza, with a view to pandemic preparedness.

As of November 2025, U.S. FDA-approved avian influenza vaccines are not commercially available. On December 11, 2024, the U.S. administration informed the media that there are no active plans to authorize the distribution of avian influenza (bird flu) vaccines. On June 27, 2024, the U.S. Centers for Disease Control and Prevention (CDC) confirmed that its avian vaccination program was inactive in the United States. According to the CDC, about 20 million doses of H5N1 and 12 million doses of H7N9 vaccines were available in the National Strategic Stockpile as of June 2023. The CDC also confirmed in October 2023 that an H5 candidate vaccine virus (CVV) similar to the hemagglutinin (HA) protein of H5N1 clade 2.3.4.4b A(H5) Candidate Vaccine Virus Development (pg. 37). The CDC says this H5 CVV could be used to produce a highly pathogenic avian influenza (HPAI) A(H5N1) virus vaccine for people.

The U.S. National Influenza Vaccine Modernization Strategy and the American Pandemic Preparedness Plan outlined the United States' priorities for the development and deployment of avian and pandemic influenza vaccines. As of 2025, the U.S. Influenza & Emerging Infectious Diseases (EID) Pandemic Vaccines and Adjuvants Program has advanced vaccination strategies to mitigate future pandemics. It also manages the U.S. National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) and implements its strategic use in the event of a public health emergency. The NPIVS uses the HHS Influenza Risk Assessment Tool (IRAT), updated in July 2023 and administered by the CDC, to identify and evaluate potential pandemic influenza threats.

On April 21, 2024, the APHIS National Veterinary Services Laboratories made available 239 genetic sequences from the H5N1 clade 2.3.4.4b influenza virus recently identified in samples associated with the ongoing highly pathogenic avian influenza (HPAI) outbreak in the U.S. H5N1 is divided into several clades, each with its own geographic and clinical significance.

Avian Influenza Vaccine Effectiveness

A Brief Communication published by the journal Nature Medicine on July 16, 2024, included the stockpiled US-licensed adjuvanted H5N1 vaccines. These vaccines generate cross-neutralizing antibodies against circulating HPAI H5N1 clade 2.3.4.4b in humans and may be helpful as bridging vaccines until updated H5N1 vaccines become available. Furthermore, the U.S. Food and Drug Administration (FDA), the United Kingdom, and European agencies say annual flu shots are unlikely to protect people during avian/pandemic influenza (bird flu) pandemics.

U.S. FDA-Approved Avian Influenza Vaccines

On September 15, 2009, four influenza vaccine manufacturers received approval from the FDA to use the 2009 monovalent influenza A (H1N1) vaccine to prevent outbreaks caused by the 2009 pandemic influenza A (H1N1) virus. BARDA is partnering with GSK and CSL Seqirus to manufacture investigational lots of H5N8 vaccines and clinically assess the adjuvancy, immunogenicity, and dose-sparing ability of the adjuvants combined with the manufactured vaccines.

The U.S. FDA authorized CSL Seqirus Inc. Audenz™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), a cell-based vaccine, on January 31, 2020. CSL Seqirus has developed prophylactic vaccines to address the H5N1 threat posed by the virus, using egg-based technology at its Liverpool, UK facility (where the virus grows in eggs) and cell-based technology at its Holly Springs, NC facility (where the virus grows in cells).

On November 14, 2013, the FDA licensed the I.D. Biomedical Corporation Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (STN#: 125419), to prevent H5N1 influenza disease. The vaccine was not commercially available in 2024, but the U.S. federal government purchased it for the National Stockpile for as-needed distribution.

Sanofi Pasteur's Influenza Virus Vaccine, H5N1, was approved by the FDA in 2007.

Through six awards, CSL Seqirus has been working with the U.S. BARDA to support U.S. pandemic preparedness objectives. On October 4, 2024, CSL Seqirus received a new BARDA award to complete the fill-and-finish process for an additional pandemic vaccine. This $34 million investment further supports the U.S. government's response to the outbreak and preparedness efforts. It is the Six Avian Influenza Pandemic Preparedness Award presented to CSL Seqirus by BARDA. On September 25, 2024, CSL Seqirus announced an award of $121.4 million. As part of the NPIVS, it would expand its reserves of MF59® adjuvant to the equivalent of 40 million doses and expand its Vendor-Managed Inventory program for its proprietary MF59® adjuvant.

On May 30, 2024, CSL Seqirus announced that BARDA selected it to complete the fill-and-finish process of the pre-pandemic avian influenza vaccine for the U.S. government as part of the NPIVS program. The company stated that it intends to deliver approximately 4.8 million doses of pre-pandemic vaccine that are H5-matched to the H5 component of the currently circulating H5N1 strain.

CSL Seqirus announced on August 28, 2023, that BARDA selected the company to deliver one bulk lot of H5N8 A/Astrakhan antigen to support the U.S. government's pandemic response readiness under contract number 75A50122D00004 ($46.3 million). Seqirus received an award from BARDA to produce an A/Astrakhan virus vaccine, the seed, and subsequently announced the selection of CSL Seqirus to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study. Under the $30.1 million agreement, CSL Seqirus has established and maintains the required pandemic-readiness, delivering 150 million doses of cell-based pandemic influenza vaccine within 6 U.S. months of an influenza pandemic declaration in the U.S. In 2022, Sequirus's Holly Springs facility successfully achieved BARDA's criteria to establish domestic manufacturing capability for innovative cell-based seasonal and pandemic influenza vaccines.

On October 5, 2022, CSL announced results from the preclinical studies of the company's self-amplifying messenger RNA (sa-mRNA) influenza vaccine candidates. The data, published in Molecular Therapy – Methods and Clinical Development, indicate that the sa-mRNA influenza vaccine candidates elicited a potent, cross-reactive immune response against pandemic and seasonal influenza strains A(H5N1) and A(H1N1) (Also Known as Swine flu). Roberta Duncan, CSL's mRNA Program Lead, commented in an article in March 2024, "The innovation of sa-mRNA brings the opportunity to provide greater public health protection against respiratory viruses and in other disease states."

Avian Influenza Vaccine Candidate

On November 6, 2025, researchers at the University of Maryland School of Medicine's Center for Vaccine Development and Global Health announced encouraging results from an early-phase clinical trial that found an experimental intranasal vaccine triggered a broad immune response against multiple strains of H5N1. They reported a randomized, controlled phase I trial of a recombinant influenza A/H5 (A/Indonesia/05/2005, clade 2.1) hemagglutinin vaccine formulated with a nanoemulsion adjuvant (W805EC).

On July 24, 2025, Novavax, Inc. announced preclinical data demonstrating that its avian pandemic influenza vaccine candidate induced robust immune responses following either a two-dose intranasal or a two-dose intramuscular regimen in nonhuman primates. The results were published in Nature Communications.

Canada Avian Influenza Vaccine

GSK—I.D. Biomedical Corporation of Quebec's Arepanrix H5N1 A/American wigeon clade 2.3.4.4b vaccine is approved by the U.S. FDA. It uses established technology for seasonal and pandemic flu vaccines approved in Canada. On February 19, 2025, the Public Health Agency of Canada released the National Advisory Committee on Immunization's Preliminary guidance on human vaccination against avian influenza in a non-pandemic context as of December 2024.

China Pandemic Influenza Vaccine

SINOVAC's whole-virus inactivated H5N1 pandemic influenza vaccine, Panflu®, is supplied to the Chinese government's stockpiling program.

European Avian Influenza Vaccines

According to the European Medicines Agency (EMA), one vaccine (Aflunov) is authorized for use in the European Union (EU) during avian influenza outbreaks within notarized pandemic mic. Aflunov contains a flu strain called A/turkey/Turkey/1/2005 (H5N1)-like strain (NIBRG-23) (clade 2.2.1). Additionally, the EMA says that four pandemic-preparedness influenza vaccines authorized in the EU can be rapidly modified to protect people during a pandemic. EMA's human medicines committee recommended Celldemic at its February 2024 meeting (zoonotic influenza vaccine [H5N1] [surface antigen, inactivated, adjuvanted, prepared in cell cultures]). This vaccine is intended for immunization during outbreaks of influenza coming from animals, including when public health authorities anticipate a possible pandemic. Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)) is a pandemic preparedness vaccine intended for use only if a flu pandemic has been officially declared.

On June 11, 2024, CSL Seqirus announced it would provide 665,000 pre-pandemic (zoonotic) vaccines to the EC's fifteen EU and EEA Member States. Seqirus UK Ltd has an EU-wide modified marketing authorization for this avian influenza vaccine for use in adults. On June 5, 2024, Andrew Joseph wrote that Finland may become the first country to offer 'bird flu' vaccinations to people this year. The zoonotic influenza vaccine Seqirus is used in Finland.

The European Commission (EC) signed a framework contract on July 22 for the joint procurement of GSK's Adjuvanted Pandemic Influenza Vaccine (Adjupanrix). As a result, EC Member States can purchase up to 85 million vaccine doses during an influenza pandemic.

Japan Avian Influenza Vaccines

Japan's Health Ministry announced in May 2023 that it is updating its avian influenza vaccine stockpile from H7N9 to H5N1. On May 25, 2023, local media reported that Japan plans to stockpile 10 million vaccine doses for its population. In 2018, Japan initiated another cull program for infected chickens. In 2008, Japan started testing bird flu vaccine versions. In 2003, after 79 years, the H5N1 Highly Pathogenic Avian Influenza (HPAI virus was detected in dead chickens.

United Kingdom Influenza Pandemic Vaccines

The UK Health Security Agency announced on September 2 an advanced purchase agreement with CSL Seqirus to produce over 100 million influenza pandemic vaccines if needed. On December 3, 2024, the UK Government purchased over five million doses of the human H5 influenza vaccine manufactured by CSL Seqirus UK Limited, a UK-based healthcare company.

Avian Influenza Vaccine Adjuvant

According to Vanderbilt University Medical Center research published in The Journal of Infectious Diseases (January 2024), avian (bird) influenza vaccines created a more robust immune response in a phase 1 study paired with the GSK-manufactured AS03 adjuvant.

mRNA Pandemic Influenza Vaccine Candidates

On April 10, 2025, Arcturus Therapeutics Holdings Inc. announced that the U.S. FDA had granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate ARCT-2304. This vaccine candidate is designed for active immunization to protect against disease caused by the influenza A H5N1 subtype contained in the vaccine. ARCT-2304 (LUNAR-H5N1) is a STARR® sa-mRNA vaccine candidate formulated with Arcturus' proprietary LUNAR® delivery technology.

Moderna initiated a Phase 1/2 study in July 2023 to generate safety and immunogenicity data for the investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years and older. The study includes vaccine candidates against H5 and H7 avian influenza viruses. Results from the study are expected in 2025 and will inform Phase 3 development plans. On January 17, 2025, the U.S. government awarded Moderna $590 million to continue vaccine development.

Argentinian manufacturer Sinergium Biotech is leveraging the WHO and the Medicines Patent Pool's mRNA Technology Transfer Programme. Sinergium has developed candidate H5N1 vaccines and aims to demonstrate the concept in preclinical models. Once the preclinical data package is concluded, the technology, materials, and expertise will be shared with other manufacturing partners.

In April 2024, the U.S. FDA granted CurVac N.V. Fast Track designation for a monovalent influenza A (H5N1) pre-pandemic mRNA vaccine candidate encoding an H5 antigen. The candidate is being developed in collaboration with GSK. The start of Phase 1, part of a combined Phase 1/2 study, was announced on April 24, 2024.

Arcturus Therapeutics Holding Inc.'s ARCT-2304 is a sa-mRNA vaccine candidate formulated within a lipid nanoparticle (LNP). The sa-mRNA vaccine candidate is designed to produce numerous copies of mRNA within the host cell after intramuscular injection, thereby achieving enhanced expression of haemagglutinin (HA) and neuraminidase (NA) antigens, and allowing lower doses than conventional mRNA vaccines. The FDA issued a "Study Can Proceed" notification on November 11, 2024.

Vir Biotechnology Pandemic Monoclonal Antibody

On October 4, 2022, the BARDA awarded California-based Vir Biotechnology, Inc. a multi-year contract with a potential value of up to $1 billion to advance the development of a complete portfolio of innovative solutions (vaccines) to address influenza and other infectious disease threats. BARDA will initially invest approximately $55 million to support ongoing and future development of VIR-2482, an investigational prophylactic monoclonal antibody (mAb) designed to protect against seasonal and pandemic influenza. On July 20, 2023, Vir announced that the Phase 2 PENINSULA trial, evaluating VIR-2482 for the prevention of symptomatic influenza A illness, did not meet its primary or secondary efficacy endpoints.

South Korea Avian Influenza Vaccine Candidate

SK Bioscience announced on May 6, 2025, that it has been selected for the Korea Disease Control and Prevention Agency Priority Infectious Disease Pandemic Preparedness Rapid R&D Support Program. This government-led initiative aims to develop vaccines against avian influenza, which has been identified as a high-risk candidate for the next pandemic.

Avian Influenza Vaccines for Birds

Boehringer Ingelheim VAXXITEK® HVT+IBD+H5 is a new trivalent vaccine for poultry that offers protection against Marek's disease, Infectious Bursal Disease, and H5 avian influenza.

The United States Department of Agriculture's Agricultural Research Service (APHIS) researchers confirmed on April 14, 2023, that they are currently testing several vaccine candidates for use with birds. On May 16, 2023, APHIS approved the emergency use of an HPAI vaccine to prevent additional deaths from avian influenza. The authorized vaccine is a killed, inactivated product conditionally licensed by APHIS' Center for Veterinary Biologics in 2016.

The DIVA strategy uses an activated oil-emulsion vaccine containing the same haemagglutinin (H) subtype as the challenge virus, but a different neuraminidase (N) subtype. The possibility of using the heterologous N subtype to differentiate vaccinated from naturally infected birds was investigated by developing an "ad hoc" serological test to detect specific anti-N1 antibodies.

The World Organisation for Animal Health (WOAH) announced on June 7 that it issued a comprehensive report on Avian Influenza – Policy to Action: The Case of Avian Influenza – Reflections for Change. It was recognized that a successful vaccination strategy must rely on authorized (bird flu) vaccines. "Vaccinating is not the end; it is just the beginning. Vaccination application needs to be managed along the supply chain, including a surveillance program to detect active infection in vaccinated animals," said Dr. David Swayne, Disease Expert and Forum rapporteur.

14 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Tuesday, November 25, 2025 - 07:50

Description:

Avian influenza and Pandemic vaccines are U.S. FDA approved.

Condition:

Avian Flu

UB-621 Long-Acting Herpes Treatment

UB-621 Long-Acting Herpes Treatment 2023

United BioPharma UB-621 is a long-acting monoclonal antibody (mAbs) treatment for genital herpes caused by simplex viruses 1 and 2 (HSV-1 and HSV-2). UB-621 is an anti-gD mAB that demonstrated strong viral suppression of transmission and recurrence of HSV1 and HSV2.

UB-621 is a novel, fully human mAb that interferes with HSV infection by binding specifically to HSV envelope glycoprotein D (gD). It can neutralize both wild-type HSV lab strains and multi-drug-resistant clinical isolates. UB-621 exhibited a high-affinity binding (Kd, 3.6 × 10-11 M) to gD protein and high potency against HSV-1 and HIV-2 infections. UB-621 also can inhibit the cell-to-cell spread of HSV-1 and HSV-2.

UB-621 has been developed over ten years of research collaboration between the University of Washington, the U.S. National Institute for Allergy and Infectious Diseases, the University of Duisburg Essen, Germany, and Dartmouth College, USA. The phase 2 clinical study with 44 people was last updated on May 18, 2022, with an Estimated Study Completion Date of January 31, 2025.

UBP's cell line, process development, protein analysis, and formulation methods empower the develop a high titer, robust, scalable cell culture and establish an optimized yield and robust mAbs drug purification process. UBP has developed more than 30 analytical development methods and validation for physiochemical and protein characterization, drug formulation development, comparability studies, and quality control.

Shanghai Public Health Clinical Centre and Cheng Kung University's Department of Microbiology and Immunology have joined United BioPharma's fight against the global herpes endemic. Together with United BioPharma, the two institutions will test the effectiveness of UB-621 in the U.S. and China.

UBP's Headquarters Centers of Excellence in R&D and Manufacturing is located at 45-1 Guangfu N. Rd., Hukou Industrial Park, Hukou Township, Hsinchu County, TAIWAN 30351.

HSV Tests 2023

The U.S. Preventive Services Task Force recommends against routine serologic screening for genital HSV infections in 2023. However, herpes tests can be ordered online in the U.S. at Ultalabtests.

UB-621 Indication

United BioPharma's UB-621 – with a half-life of 23-28 days, which may allow a monthly or quarterly dosing scheme to treat HSV infection.

UB-621 Administration

UB-621 is administered via subcutaneous injection and targets surface glycoprotein gD found to inhibit viral entry into cells. A subcutaneous liquid formulation may allow a monthly or quarterly dosing scheme to treat HSV infection.

UB-621 Dosage

In an open-label, dose-escalation Phase 1 study, UB-621 was demonstrated to be safe and well-tolerated in 15 healthy volunteers receiving a single subcutaneous injection at doses ranging from 0.1 mg/kg to 5 mg/kg. The phase 2 study evaluates 2.5 mg/kg UB-621 group mAb and by SC administration 5 mg/kg UB-621 group. The Estimated Study Completion Date is January 31, 2025.

UB-621 News 2023

October 18, 2021 - UB-621 will be heading into Phase 2 clinical trials in the United States and China. "Data from our initial trials suggest that UB-621 is not only a best-in-class treatment but a potential game-changer for billions of patients suffering from herpes worldwide. In addition, testing on clinical isolates will help confirm whether UB-621 can work well against herpes strains, especially those that have already been shown to be resistant to currently marketed drugs", said Dr. Shugene, Lin, President of United BioPharma.

July 13, 2021 - United BioPharma announced that its subsidiary company in Shanghhadhas received Investigational New Drug approval from China's National Medical Products Administration for a Phase 2 clinical trial with UB-621.

November 10, 2020 - United BioPharma announced they had received Investigational New Drug approval from China National Medical Products Administration to conduct a Phase 2 clinical trial with UB-621.

August 5, 2020 - United BioPharma (UBP) announced that it received approval for an Investigational New Drug from the Taiwan Food and Drug Administration to conduct a Phase 1 clinical trial with UB-421 SC, an anti-CD4 monoclonal antibody formulated for subcutaneous injection in treatment-naïve, HIV-1 infected patients.

UB-621 Clinical Trials

UB-621 has completed a Phase 1 clinical trial and has launched a Phase 2 clinical trial that was Last Updated on May 18, 2022.

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Manufacturer:

United BioPharma

Reviewer:

Robert Carlson, MD

Vaccine:

UB-621 Long-Acting Herpes Treatment

Generic:

UB-621

Drug Class:

anti-gD monoclonal antibody

Clinical Trial Phase I:

Study to Evaluate Safety, Tolerability, and Pharmacokinetics of UB-621 in Healthy Volunteers

Clinical Trial Phase II:

UB-621 HSV Monoclonal Antibody

Condition:

Herpes

Last Reviewed:

Wednesday, May 10, 2023 - 06:05

Status:

Candidate

Manufacturer Country ID:

Countries:

China - pending

Audenz Avian Influenza Vaccine

Audenz™ Avian Influenza H5N1 (Bird Flu) Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects

CSL Seqirus Inc. Audenz™ (aH5N1c) (STN: 125692) is a monovalent, adjuvanted, cell-based inactivated subunit vaccine designed to protect people from disease caused by the influenza A virus H5N1 subtype in the event of avian influenza pandemics. During H5N1 bird flu pandemics, a lack of preexisting immunity to novel influenza strains increases morbidity and mortality. Audenz is a milky-white sterile injectable emulsion prepared from a virus propagated in Madin Darby Canine Kidney cells for intramuscular use.

Audenz's initial U.S. Food and Drug Administration (FDA) Approval was in January 2020 for use in persons six months and older, and it received Supplemental FDA approval in 2021. Clinical safety data for AUDENZ in adults have been collected from three studies: Study 1 in adults 18 through 64 years of age (NCT01776541); Study 2 in adults 65 years of age and older (NCT01766921), and Study 3, a placebo-controlled trial in adults 18 years of age and older (NCT02839330). Subjects in all studies received two doses of AUDENZ, administered intramuscularly 21 days apart. Limited adverse events were detected.

CSL Seqirus has produced zoonotic vaccines to address the H5N1 threat using egg-based technology at its Liverpool, UK facility (virus grown in eggs) and cell-based technology at its Holly Springs, NC facility (virus grown in cells). The Holly Springs, NC, facility was built through a public-private partnership established in 2009 with BARDA. It is the world's largest cell-based influenza vaccine producer and the first such domestic facility.

Both technologies utilize CSL Seqirus' MF59®-adjuvanted technology and have been proven capable of producing vaccines against various strains of pandemic potential. The current egg-based adjuvanted zoonotic vaccine is based on the approved Aflunov platform, while the cell-based adjuvanted zoonotic vaccine is produced based on the approved Audenz platform.

The journal Vaccines confirmed on December 11, 2021, four studies (total N = 6,230) assessed the immunogenicity and safety of mammalian cell-based, MF59®-adjuvanted, A/H5N1 vaccine (aH5N1c; AUDENZ) as two doses administered on Days 1 and 22 in children (NCT01776554), adults (NCT01776541; NCT02839330), and older adults (NCT01766921; NCT02839330). Overall, an age-related response was evident, with the highest responses observed in children <3 years old. In children, antibody titers met seroconversion criteria 12 months after vaccination.

On March 23, 2022, a peer-reviewed study published by the journal Vaccines reported that 'A cell-based process' may be better suited for vaccine production during an HPAI pandemic; the aH5N1c influenza vaccine (Audenz) elicited high levels of antibodies following two vaccinations administered 21 days apart and met immunogenicity criteria at Day 43 among both younger and older adults with a clinically acceptable safety profile. The consistency of the three consecutive aH5N1c vaccine lots was demonstrated in a phase 3 study.

Seqirus has a five-year agreement with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Assistant Secretary for Preparedness and Response Office (ASPR) within the U.S. Department of Health and Human Services, to supply products. Avian influenza vaccines ensure that people can be vaccinated as directed by the U.S. National Influenza Vaccine Modernization Strategy and the American Pandemic Preparedness Plan. On June 2, 2022, the U.S. government confirmed that Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of a cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S. During a bird-flu pandemic in the U.S., BARDA would source vaccines from the CSL Seqirus Holly Springs, NC facility in a pandemic. BARDA certified this facility in June 2022. The product is not marketed directly to consumers or available through traditional retail channels.

An alternative to traditional egg-based manufacturing, cell-based manufacturing avoids egg-adapted changes, one source of strain mismatch between the vaccine and circulating pandemic influenza virus. The antigen is stockpiled and, in the event of an influenza A (H5N1) pandemic, would be rapidly formulated into doses for the U.S. government. Audenz combines Seqirus's proprietary MF59® adjuvant technology with its cell-based manufacturing platform. Access to pre-pandemic vaccines using either cell- or egg-based manufacturing technologies from SeqSeqirus'sobal production facilities, including Holly Springs, North Carolina; Liverpool, United Kingdom; and Parkville, Australia.

As of 2024, the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) consider the current risk to the general public from the ongoing H5N1 outbreak in wild birds, poultry, and mammals to be low. The WHO published the Pandemic Influenza Pandemic Framework's partnership Contribution High-Level Implementation Plan III, which outlines the strategy for strengthening global pandemic influenza preparedness from 2024 to 2030.

U.S. FDA STN: 125692; BLA Approval; Supplemental Approval Letter: BL125692/18; Package Insert. There is no postmarketing experience following the administration of AUDENZ, and no data are available to evaluate the concomitant administration of AUDENZ with other vaccines. There is insufficient data on AUDENZ in pregnant women to inform vaccine-associated risks in pregnancy.

New Jersey-based CSL Seqirus is a global leader in influenza prevention (ASX: CSL). Its trademark is 88789443.

Audenz Vaccine Indication

Audenz is indicated to protect individuals six months of age and older against influenza A(H5N1) in a pandemic. Do not administer AUDENZ to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component or after a previous dose of an influenza vaccine.

Audenz Vaccine Dosage

Audenz is administered as an intramuscular injection. It is given in two doses, .5 ml each, 21 days apart. The U.S. FDA approved a multi-dose vial presentation for Audenz on November 23, 2021.

Audenz Vaccine Immunocompromised

Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AUDENZ.

Audenz Vaccine Side Effects

In adults 18 through 64 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (64%), fatigue (25%), and headache (25%). Avoid use if there is any history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component or after a previous dose of an influenza vaccine. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1855358, VAERSAERS at 1800822,7,967, or www.vaers.hhs.gov.

Audenz Vaccine Serious Adverse Events

In Clinical Study 3, the FDA disclosed fatal and non-fatal SAEs reported in the 12 months following vaccinations among adults 18 through 64 years of age occurred in 2.9% of subjects who received AUDENZ and 3.3% of subjects who received placebo. SAE rates among adults 65 and older were 10.5% in subjects administered AUDENZ and 15.3% in subjects who received a placebo. Fatal SAEs included 11 (0.5%) AUDENZ recipients and 1 (0.1%) placebo recipients. No SAEs were assessed as being related to AUDENZ. Studies 1 and 2 did not have a placebo or active comparator control for safety comparison. Four deaths occurred in Study 1 (subjects 18 through 64 years) and two in Study 2 (subjects ≥ 65 years), none assessed as related to AUDENZ. In the 12 months following vaccinations, SAEs (fatal and non-fatal) occurred in n=28 (3%) of all subjects in Study 1. SAEs occurred in a total of n=96 (7%).

Pandemic Influenza Vaccines

Pandemic influenza occurs when a new flu virus emerges for which humans have little or no immunity, allowing the virus to spread rapidly from person to person worldwide. Under the terms of an agreement in May 2024, CSL Seqirus will deliver approximately 4.8 million pre-pandemic vaccines matched to the H5 of the currently circulating H5N1 strain. This is the fourth award CSL Seqirus has received from BARDA.

Audenz Vaccine News

October 4, 2024 - "Pandemic preparedness is a core part of who we are," said Jon Kegerise, Vice President of Manufacturing and Site Head at CSL Seqirus Holly Springs. "Our Holly Springs site was built to deliver innovative pandemic solutions at industrial scale and speed."

May 16, 2024 - Do We Have Enough Bird Flu Vaccines for a Potential Pandemic?

June 14, 2023 - The U.S. CDC published H5N1 Bird Flu: Current Situation Summary.

April 14, 2023—The United States Department of Agriculture's Agricultural Research Service researchers are testing several vaccine candidates. Initial data from the animal study with a single dose of the vaccine are expected to be available in May 2023. The researchers expect two-dose vaccine challenge studies with results in June 2023.

December 21, 2022 - The UKHSA published an original Research and Analysis investigation into the risk to human health of avian influenza (influenza A H5N1) in England: technical briefing #1.

July 29, 2022 - "It is best practice never to touch or handle deceased birds or exhibit signs of distress or illness," says Dr. Sundari Mase, Sonoma County health officer. "While severe cases of bird flu are possible in humans, we rarely see symptoms develop beyond those of the common cold."

J "ne 2, 2022 - CSL Seqirus announced its facility in Holly Springs, North Carolina. As the Biomedical Advanced Research and Development Authority outlined, it has achieved all the criteria to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines.

May 26, 2022: The journal Nature published "Why unprecedented bird flu outbreaks sweep the world," which concerns scientists.

May 17, 2022 - The U.S. CDC recently added the Eurasian H5N1 avian flu strain to the list of animal flu viruses with zoonotic potential.

April 2022—The United States Department of Agriculture's Animal and Plant Health Inspection Service confirmed the presence of HPAI in a commercial pheasant flock in Erath County, Texas, to confirm a HAPI outbreak in 2022.

February 25, 2022 - Seqirus announced the renewal of a five-year agreement with the BARDA, a division of the Office of the Assistant Secretary for Preparedness and Response. This agreement empowers BARDA to request that Seqirus provide influenza vaccines and adjuvants for pre-pandemic stockpiling or manufacture to support rapid response to an influenza pandemic or other public health emergency. Seqirus and BARDA have held similar agreements since 2006.

November 23, 2021: The FDA has approved AUDENZ's multi-dose vial presentation to help protect individuals six months of age and older against influenza A(H5N1) during a pandemic.

October 4, 2021 - Seqirus announced that the Biomedical Advanced Research and Development Authority selected Seqirus to develop two influenza A(H2Nx) vaccine candidates for assessment in Phase 1 clinical study to help safeguard communities in the event of an influenza pandemic. The first candidate will utilize cell-based and adjuvanted technologies, building on SeqSeqirus'sghly flexible combination platform technology used by AUDENZ.

February 3, 2020 - Seqirus Announces U.S. FDA Approval of Its First Adjuvanted, Cell-Based Pandemic Influenza A (H5N1) Vaccine.

January 31, 2020 - The FDA approved Seqirus' Biologics License Application for Influenza A (H5N1) Monovalent Vaccine, Adjuvanted effective in persons six months and older. For use in persons six months through 17 years of age, the FDA has approved the BLA according to the regulations for accelerated approval, 21 CFR 601.41.

Audenz Influenza A(H5N1) Vaccine Clinical Trials

Audenz has been studied in various clinical trials.

0 min read

Manufacturer:

CSL Seqirus

Reviewer:

Robert Carlson, MD

Vaccine:

Audenz Avian Influenza Vaccine

VIS:

PDF

Availability:

U.S.

Generic:

aH5N1c

Clinical Trial:

https://www.seqirus.com/r-and-d/research-practices

Drug Class:

Monovalent Adjuvanted Pandemic Influenza vaccine

Find Price:

Discounts

Clinical Trial Phase I:

Dose Ranging Study to Evaluate Immunogenicity and Safety of Adjuvanted or Non-adjuvanted Cell Culture-derived H5N1 Influenza Vac

Clinical Trial Phase II:

A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine

Clinical Trial Phase III:

Safety and Immunogenicity of Two Doses of aH5N1 Vaccine in Adult and Elderly Subjects With and Without Immunosuppressive Conditi

Lab Test:

CDC

Condition:

Pandemic Influenza

Availability Link:

US government

Last Reviewed:

Friday, January 3, 2025 - 15:55

Brand:

Audenz

CPT Code:

AMA

Status:

Approved

Manufacturer Country ID:

FDA First In Class:

Yes

Kosher:

Yes

Halal:

Yes

Side Effects:

Ingredients:

Countries:

Cell Line Production:

Madin Darby Canine Kidney

Rate Vaccine:

ubcKXs5r

Lyme PrEP Antibody Treatment

Lyme PrEP Antibody Treatment 2022

Lyme PrEP uses a single human antibody, or blood protein, to kill the bacteria in the tick’s gut while the tick drinks its victim’s blood before the bacteria can get into the human host. The testing pre-exposure prophylaxis delivers a monoclonal antibody to provide immediate immunity against Lyme disease.

A panel of anti-OspA human mAbs (HuMAbs) as potential prophylaxis for Lyme disease was developed. In particular, HuMAb 2217 was shown to be borreliacidal (EC50 < 1 nM) against B. burgdorferi, B. afzelii, and B. garinii, the three main genospecies endemic in the United States, Europe, and Asia. In addition, when passively administered to mice before challenge with B. burgdorferi–infected Ixodes ticks, HuMAb 2217 completely prevented transmission after a single dose of 10 mg/kg.

One challenge to developing 2217 for Lyme disease prevention is to ensure that the antibody sustains a protective plasma concentration for the entire tick season.

HuMab 2217 was modified (HuMab 2217LS) to successfully double its half-life, which could provide sufficient protection during the Lyme disease season.

Lyme PrEP Antibody Treatment Indication

Lyme PrEP would be indicated for those populations living in areas where black-legged or deer ticks are found. It prevents infection by delivering a single human anti-Lyme antibody, or blood protein, directly to a person rather than triggering their immune system to make many antibodies as vaccines do. If a person’s blood contains the correct antibody against the bacteria, the antibody can kill Borrelia in the tick’s gut before the bacteria has a chance to travel to the person.

Lyme disease in humans is characterized by erythema migrans (EM), fever; fatigue; musculoskeletal pain; and the potential for neurological, cardiac, or joint manifestations. The CDC has estimated that over 476,000 Americans are diagnosed with and treated for Lyme disease each year.

Lyme PrEP Antibody Treatment Dosage

Phase 1 trial indicates that a single shot will give protection for the necessary amount of time but will be confirmed during the later phases of the clinical trials.

Lyme PrEP Antibody Treatment Side Effects

Unlike a vaccine, which induces antibodies that may not contribute to protection but can cause side effects, the Lyme PrEP approach uses a single, defined antibody, thus reducing the risk of side effects.

Lyme PrEP Antibody Treatment News 2020 - 2022

May 5, 2022 - A Phase I clinical trial of a preventive Lyme disease shot developed by MassBiologics of UMass Chan Medical School is nearing completion, and the subsequent trial phase may begin as soon as next spring, according to Mark Klempner, MD, professor of medicine and former executive vice chancellor for MassBiologics.

March 11, 2021 - Video: Preventive shot for Lyme disease, now in a clinical trial, explained.

June 4, 2020 - A Lyme disease vaccine doesn’t exist, but a yearly antibody shot shows promise at preventing infection.

Lyme PrEP Antibody Treatment Clinical Trial

LymePrEP Phase 1 clinical trial. The trial title is First Clinical Study of the Safety and Blood Levels of a Human Monoclonal Antibody (2217LS) Against Lyme Disease Bacteria in Healthy People. “The goals for the Phase I clinical trial are to test for the safety of Lyme PrEP and to determine how long it lasts in the bloodstream in humans. During the Phase I trial, 48 volunteers who had never been exposed to Lyme disease participated in the trial in Nebraska, where the disease is not endemic. The Phase I trial will end in August.

The Phase II-III clinical trial is under development and is anticipated to begin in Spring 2023.

0 min read

Manufacturer:

MassBiologics

Reviewer:

Robert Carlson, MD

Vaccine:

Lyme PrEP Antibody Treatment

Generic:

Lyme PrEP

Drug Class:

Monoclonal Antibody