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Herpes Vaccine Candidates

Herpes Vaccines December 2025

Developing protective vaccines against the herpes simplex virus (HSV) has been a longstanding challenge in clinical trials. Current herpes vaccine candidates are based on DNA, modified mRNA, subunit, killed-virus, and attenuated-live-virus technologies. As of December 11, 2025, the U.S. Food and Drug Administration (FDA), Brazil, Canada, China, the European Union, India, Japan, and the United Kingdom had not authorized preventive or therapeutic vaccines for herpes simplex virus types 1 (HSV-1) or 2 (HSV-2).

The World Health Organization (WHO) published its preferred product characteristics for Alpha (α)-herpesviruses vaccines and updated its pipeline review in late 2024. In coordination with its Global Health Sector Strategy on HIV, viral hepatitis, and sexually transmitted infections for 2022-2030, the WHO works to increase awareness about genital herpes infections and related symptoms. The WHO, the U.S. National Instuties of Health (NIH), and global partners launched STI Watch, a portal containing updated information on vaccine development status. Both preventive and therapeutic HSV vaccines are being explored.

A study published in July 2024 showed that the economic costs of genital herpes infections amount to an estimated $35 billion a year worldwide through healthcare expenditures and productivity loss. To confirm HSV infections, commercial labs offer confidential testing services in 2025.

As of 2025, herpes vaccine candidates conducting clinical trials include:

Assembly Biosciences ABI-5366 is an advanced helicase primase inhibitor targeting Healthy Participants and Participants Seropositive for HSV-2 With Recurrent Genital Herpes. The Phase 1a/1b clinical trial (NCT06385327, ABI-5366-101) found that ABI-5366 was well-tolerated and presented a pharmacological profile supporting potential once-weekly or even once-monthly dosing.

mRNA-1608 is an mRNA vaccine candidate against HSV-2 disease. The mRNA-1608-P101 Phase 1 study was launched on September 6, 2023, and is expected to be completed on June 4, 2025. With mRNA-1608, Moderna Inc. aims to induce a strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity—Independent Study: An mRNA vaccine to prevent genital herpes.

BNT163 is an mRNA-based HSV vaccine candidate that encodes three HSV-2 glycoproteins. These glycoproteins help prevent HSV from entering and spreading within cells and counteract HSV's immunosuppressive properties.

RatioVaccines' VC2 vaccine candidate is a live-attenuated vaccine targeting facial, ocular, and genital herpes caused by HSV-1 and may also protect against genital herpes caused by HSV-2. On October 13, 2023, Rational Vaccines was awarded $2.8 million by the U.S. National Institutes of Health. In 2018, a study conducted at Louisiana State University, Brent Stanfield and colleagues examined the immune response generated by the intramuscular injection of the VC2 vaccine in guinea pigs.

Delta gD-2 (∆gD-2) is a vaccine candidate based on an HSV-2 virus genetically deleting glycoprotein D (gD-2).

HSV529 (HSV15) is a vaccine candidate classified as replication-defective. This means the virus possesses all components of the wild-type HSV, except for two proteins, UL5 and UL29, which are involved in viral DNA replication. Sanofi Pasteur and the National Institute of Allergy and Infectious Diseases last updated this phase 1/2 study on January 13, 2021.

EXD-12 is a vaccine candidate currently tested for safety and efficacy as a prophylactic and therapeutic vaccine against herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2).

NanoVax is an adjuvant platform to develop a vaccine candidate to protect against the two viruses that can cause genital herpes.

RVx201 is a live-attenuated HSV-2 vaccine candidate conducting an observational clinical study, RVx-001-PSS, in England. It is designed to achieve a specific degree of attenuation through mutations engineered into the ICP0 protein.

Shanghai BD Gene is conducting a phase 1/2 clinical study in humans. It is the only gene-editing technology for Cas9 mRNA delivery by lentivirus.

Assembly Biosciences, Inc. announced data from development candidate ABI-5366, a long-acting HSV helicase inhibitor targeting high-recurrence genital herpes.

A research study published on May 28, 2024, highlights the potential of an effective combination therapy using the two monoclonal anti-gB IgGs (HDIT101 and HDIT102) for the treatment of HSV-1 and HSV infections.

GSK plc announced on September 11, 2024, that it had completed the primary objective data analysis from the phase II part of the TH HSV REC-003 trial for GSK3943104, a therapeutic HSV vaccine candidate. The results show that GSK3943104 did not meet the study's primary efficacy objective. Therefore, this vaccine candidate will not progress to phase III studies.

Herpes Vaccine Candidate Clinical Trials

When developing herpes vaccines, participants are selected for clinical trials in phases 1, 2, 3, and 4. Each development phase is essential. Herpes Cure Advocacy launched Herpes Cure Pipeline 2.0 in March 2022, which tracks the timelines and strategies of preclinical and clinical studies. The Vaccine Value Profile (VVP) for HSV aims to provide a comprehensive, high-level assessment of the information and data currently available to inform the potential public health, economic, and societal value of pipeline vaccines and vaccine-like products.

Herpes Vaccine Preclinical Development

Redbiotec is developing an HSV-2 therapeutic vaccine, also known as immunotherapy. Their vaccine program uses T-cell-mediated protection and aims to outperform antivirals. With two injections, patients can remain symptom-free for over 12 months.

Eurocine vaccine candidates against HSV-2—In a non-human study, mRNA vaccination stimulated potent T cell responses that significantly outcompeted those generated by the protein vaccine in performance in several specific areas. Dr. Karl Ljungberg, Director of Preclinical Development at Eurocine Vaccines, stated in December 2022, "The T cell responses that we report here align with those that can be detected after recovery from an infection and are focused on the part of the HSV-2 virus that we believe is important to target to obtain immunologic control of the virus."

Researchers designed and constructed an HSV-1 synthetic platform based on the H129 Strain of G4. This platform could facilitate further manipulation of the HSV-1 genome, the development of neuronal circuit tracers, oncolytic viruses, and vaccines.

A January 2025 study reviewed the development and characterization of the vaccine potential of replication-competent controlled herpesviruses, representing the first examples of regulated microbes used as vaccines.

The journal MDPI published an article on July 18, 2023, that concluded B7 costimulation molecules expressed from a replication-defective vaccine can enhance vaccine efficacy, even in an immunocompetent host.

Herpes Vaccine News

April 2, 2025 - A new study from the University of Pennsylvania School of Dental Medicine found that chewing gum made from beans has been shown to reduce the viral load of some strains of herpes.

December 10, 2024 - Around 846 million people aged between 15 and 49 are living with genital herpes infections.

September 11, 2024: GSK plc provided an update on the terminated phase I/II therapeutic HSV vaccine trial.

July 24, 2024 - An article published in Nature: TMEFF1 is a neuron-specific restriction factor for HSV.

May 13, 2024 - Fred Hutch virologists Martine Aubert, PhD, and Keith Jerome, MD, PhD, are conducting laboratory experiments to develop a gene therapy for curing herpes.

February 12, 2024 - Researchers at Dartmouth's Geisel School of Medicine and Thayer School of Engineering published a new study in Cell Reports Medicine, offering insights into how antibodies function in combating HSV infections.

December 14, 2023 - The findings of a new study (October 26, 2023) could inform the design of treatments for various viruses that replicate in the cell nucleus.

November 1, 2023 - The University of Pittsburgh School of Medicine received a grant of $ 504,000 to conduct innovative herpes research.

October 13, 2023 - Rational Vaccines was awarded $2.8 million in U.S. National Institute of Health funding in three separate grants to further its research to diagnose, treat, and prevent the spread of HSV.

September 30, 2023 - A Systematic Review was published: The Association Between Herpes Simplex Virus and Alzheimer's Disease.

May 25, 2023—Akiko Iwasaki, Ph.D., Sterling Professor of Immunobiology and professor of dermatology, molecular, cellular, and developmental biology, and epidemiology (microbial diseases) at Yale School of Medicine, developed a therapeutic vaccine candidate that may reduce the reactivation of genital herpes in guinea pigs. However, a lack of investment has hindered human clinical trials.

April 21, 2023 - The NIAID announced a Request for Information on the U.S. National Institutes of Health's vital strategic approaches to developing an HSV Strategic Plan.

April 5, 2023 - The WHO published updated Herpes Facts, including that an HSV-2 infection increases the risk of acquiring HIV.

March 20, 2023 - Research Article: Construction and characterization of a synthesized herpes simplex virus H129-Syn-G2.

December 21, 2022 - BioNTech announced that the first subject was dosed in a first-in-human Phase 1 clinical study of BNT163, an HSV prevention vaccine candidate.

December 20, 2022—Eurocine Vaccines announced that the mRNA vaccine generates superior T-cell responses. Dr. Karl Ljungberg, Director of Preclinical Development at Eurocine Vaccines, stated, "The T cell responses that we report here are in line with those that can be detected after recovery from an infection and are focused on the part of the HSV-2 virus that we believe is important to target to obtain immunologic control of the virus."

December 15, 2022 - A study published in the peer-reviewed journal PLOS Medicine found that if HSV-2 has indeed contributed to the transmission of HIV, then nearly one-third of antiretroviral costs and HIV-related wage losses add to herpes-related costs. Given the magnitude of the combined losses, a vaccine against HSV-2 must be a global priority.

December 12, 2022 - The Lancet Europe published a systematic review, meta-analyses, and meta-regressions on the epidemiology of HSV-2 in Europe.

December 9, 2022—The journal Nature published an article titled "Urgency and necessity of Epstein-Barr virus (EBV) prophylactic vaccine development." EBV is a γ-herpesvirus with a double-stranded DNA genome and is the first human oncogenic virus identified. EBV is also known as human herpesvirus 4, a member of the herpes virus family.

September 26, 2022—The Fred Hutchinson Cancer Center in Washington announced that researchers.Drs. Keith Jerome and Martine Aubert) found substantial reductions in oral and genital viral shedding in the treated mice, with many of those treated showing no detectable virus shed. A related non-peer-reviewed study was also published: AAV-delivered gene editing for latent genital or orofacial herpes simplex virus infection reduces ganglionic viral load and minimizes subsequent viral shedding.

September 23, 2022 - Nature - Scientific Reports published: HSV-1 0∆NLS vaccine elicits a robust B lymphocyte response and preserves vision without recognizing HSV-1 glycoprotein M or thymidine kinase. Collectively, the results suggest (1) the live-attenuated HSV-1 mutant 0∆NLS elicits a robust B cell response that drives select B cell responses more significantly than the parental HSV-1 and (2) HSV-1 TK and gM are likely expendable components in the efficacy of a humoral response to ocular HSV-1 infection.

Content sources include the World Health Organization (WHO), the US Centers for Disease Control and Prevention (CDC), the National Institutes of Health (NIH), research papers, ClinicalTrials.gov, and the Precision Vaccinations news network. Healthcare providers, such as Dr. Robert Carlson, fact-check content.

0 min read

Reviewer:

Robert Carlson, MD

Vaccine:

Herpes Vaccine Candidates

VIS:

PDF

Availability:

Pending

Clinical Trial:

https://clinicaltrials.gov/ct2/results?cond=&term=NCT05500053&cntry=&state=&city=&dist=

Drug Class:

Vaccine

Clinical Trial Phase I:

A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease

Lab Test:

CDC Screening

Condition:

Herpes

Last Reviewed:

Thursday, December 11, 2025 - 16:40

Status:

Candidate

Location tags:

United States of America

NasoVAX Influenza Vaccine

NasoVAX Influenza Vaccine Description

NasoVAX is a recombinant, monovalent intranasal vaccine RD-Ad5-based and is being developed for both seasonal and pandemic use. NasoVAX can activate the humoral, mucosal, and cellular immune arms in unison for a more comprehensive immune response. The data from the Phase 2a trial indicated that NasoVAX was well-tolerated and achieved 100% seroprotection with serum antibody responses comparable to a licensed injected influenza vaccine. Statistically significant increases in mucosal antibodies were noted, as well as a robust T-cell response directed against influenza.

The safety and immunogenicity of NasoVAX, a monovalent intranasal influenza vaccine based on a replication-deficient adenovirus type 5 platform, were evaluated in a placebo-controlled single ascending-dose phase 2a clinical study (ALT-103-201). Sixty healthy adults (18-49 years) received a single intranasal dose of 1×109 viral particles (vp), 1 × 1010 vp, or 1 × 1011 vp of NasoVAX or placebo. Approximately half of the subjects from the highest dose were evaluated between 12 and 14 months after initial dosing for additional immunogenicity assessment. The durability data show that the immune response elicited by NasoVAX was stable, with no overall change in the antibody titer or level of seroprotection over an average of 13 months. The combination of serum antibody, mucosal antibody, and T-cell response with the durability data provides the potential for improved protection against influenza and suggests that NasoVAX could have a more significant impact on flu symptoms and shedding of the influenza virus than currently approved influenza vaccines.

NasoVAX Influenza Vaccine Indication

NasoVAX is indicated to prevent influenza, seasonal.

NasoVAX Influenza Vaccine Dosage

NasoVAX is administered by intranasal spray. The dosage is being evaluated in clinical trials.

NasoVAX Influenza Vaccine News

March 5, 2021 - Vaccines published preliminary findings on the phase 2 clinical trial of NasoVAX. NasoVAX appeared safe and elicited a broad immune response, including humoral, cellular, and mucosal immunity, with no impact of baseline anti-adenovirus antibody at the most immunogenic dose.

June 1, 2020 - Altimmune Launches Clinical Trial Of T-COVIDTM, An Investigational Intranasal Immune Modulator For The Treatment Of Patients With Early COVID-19. The FDA has agreed that the Company may use its existing lot of RD-Ad5-based NasoVAX influenza vaccine for the planned T-COVID clinical trial,allowing the Company to initiate the study immediately

NasoVAX Influenza Vaccine Clinical Trials

NasoVAX Influenza vaccine continues to be studied in Clinical Trials.

0 min read

Manufacturer:

Altimmune

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Vaccine:

NasoVAX Influenza Vaccine

Generic:

nasal flu vaccine

Drug Class:

Nasal Flu Vaccine

Clinical Trial Phase II:

Study of the Safety and Immunogenicity of NasoVAX Extension

Condition:

Influenza

Last Reviewed:

Wednesday, September 20, 2023 - 05:50

Brand:

NasoVAX

Status:

Candidate

MVA MERS-S Vaccine

MVA-MERS-S Vaccine 2023

MVA-MERS-S (Modified Vaccinia virus Ankara) is a vaccine candidate that contains the full-length spike gene of MERS-CoV, a betacoronavirus. The vaccine is based on an attenuated virus, MVA, previously used in a smallpox eradication vaccination campaign and has now been altered to contain protein components from the MERS coronavirus. This recombinant, so-called vector-based vaccine, scientifically termed MVA-MERS-S for short, is to boost immunity against MERS coronaviruses. The MVA-MERS vaccines were produced with tPA, but either the mH5 or F11 promoter driving expression of the spike gene.

Scientists at the University Medical Center Hamburg-Eppendorf and the German Center for Infection Research (DZIF) have conducted a first-in-human phase 1 clinical trial with a vaccine against MERS. The MVA-MERS-S vaccine had a favorable safety profile without serious or severe adverse events. Homologous prime-boost immunization induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development.

In June 2023, the U.S. Centers for Disease Control and Prevention published a study that concluded: an ELISPOT assay for evaluating MERS-CoV-specific T-cell responses in dromedary camels. After a single modified vaccinia virus Ankara-MERS-S vaccination, seropositive camels showed increased levels of MERS-CoV‒specific T cells and antibodies, indicating the suitability of camel vaccinations in disease-endemic areas as a promising approach to control infection.

The German Center for Infection Research (DZIF) jointly develops new approaches to prevent, diagnose, and treat infectious diseases.

MVA-MERS-S Vaccine Indication

MVA-MERS-S is a vaccine candidate to prevent MERS, which causes respiratory disease. MERS is one of the WHO's priority diseases, warranting urgent research and development of countermeasures. Dromedary camels have been identified as natural animal reservoirs, with >90% MERS-CoV seroprevalence reported in Middle East countries, such as the Kingdom of Saudi Arabia.

MVA MERS-S Vaccine Dosage

Participants received doses of 1 × 107 plaque-forming unit (PFU; low-dose group) or 1 × 108 PFU (high-dose group) MVA-MERS-S intramuscularly for the prime immunization. A second identical dose was administered intramuscularly as a booster immunization 28 days after the first injection.

MVA MERS-S Vaccine News

June 2023 - The U.S. CDC published Volume 29, Number 6 - MERS-CoV‒Specific T-Cell Responses in Camels after Single MVA-MERS-S Vaccination.

April 21, 2020 - Promising MERS coronavirus vaccine trial on humans – useful insights for vaccine development against SARS-CoV-2. "The results of this vaccine trial are also important and promising about the development of a vaccine against SARS-CoV-2, the new coronavirus," explains Prof. Marylyn Addo, Head of the Division of Infectious Diseases at the UKE and scientist at the DZIF. "The development of the MERS vaccine provides a basis upon which we at the DZIF can rapidly develop a vaccine against the new coronavirus."

April 20, 2020 - The Lancet published a study that found vaccination with MVA-MERS-S had a favorable safety profile without serious or severe adverse events. Vaccination with MVA-MERS-S had a favorable safety profile without serious or severe adverse events. Homologous prime-boost immunization induced humoral and cell-mediated responses against MERS-CoV. A dose–effect relationship was demonstrated for reactogenicity but not vaccine-induced immune responses.

October 3, 2013 - MERS Coronavirus Spike Protein Delivered by Modified Vaccinia Virus Ankara Efficiently Induces Virus-Neutralizing Antibodies.

MVA MERS-S Vaccine Clinical Trials

Clinical Trial NCT04119440: Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety and Immunogenicity of MVA-MERS-S_DF-1.

0 min read

Manufacturer:

German Center for Infection Research (DZIF)

Reviewer:

Robert Carlson, MD

Vaccine:

MVA MERS-S Vaccine

Drug Class:

Attenuated Vaccine

Clinical Trial Phase I:

Safety, Tolerability and Immunogenicity of Vaccine Candidate MVA-MERS-S

Condition:

MERS

Last Reviewed:

Wednesday, June 21, 2023 - 06:45

Status:

Candidate

MERS Vaccines

Middle East Respiratory Syndrome (MERS) Vaccine Candidates 2025

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO), and the Kingdom of Saudi Arabia have not approved a Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine candidate as of 2025. The WHO says several vaccine candidates are being tested in human clinical trials in 2025. Efforts to develop an effective and safe human MERS-CoV vaccine have advanced, with a few vaccine candidates entering human studies; these vaccines are based on DNA plasmid vectors and modified vaccinia Ankara.

On April 10, 2023, the U.S. government announced Project-NextGen, which aims to empower companies to accelerate the development of vaccines and therapies for human coronaviruses, such as MERS.

MERS-COV Vaccine Candidates

Oxford University's Pandemic Sciences Institute and Barinthus Biotherapeutics Inc. developed the ChAdOx1 MERS vaccine and announced on September 15, 2023, that 84 people aged 50 to 70 would participate in a phase 1 study in Liverpool. This study builds upon two previous Phase I clinical trials conducted in the UK in 2018 and Saudi Arabia in 2019. VTP-500 (ChAdOx1) MERS-CoV is a vaccine candidate from the University of Oxford. It consists of the replication-deficient simian adenovirus vector ChAdOx1 ME, expressing the RS Spike protein antigen. The VTP-500 vaccine is administered as a single dose in a homologous prime-boost regimen. C regimenEPI is funding up to $34.8 million to develop and stockpile VTP-500 vaccines. Due to VTP-500's potential to significantly address the unmet need for MERS, the EMA has confirmed support for the program through the PRIME designation.

The Universitätsklinikum Hamburg-Eppendorf MVA MERS-S (Modified Vaccinia virus Ankara) vaccine candidate contains the full-length spike (S) gene of SARS-CoV-2. Vaccination with MVA-MERS-CoV had a favorable safety profile, with no severe adverse events reported. A Phase 1b study, concluded in October 2024, found that MVA-MERS-S was safe and immunogenic in individuals with previous and concurrent SARS-CoV-2 exposure.

BVRS-GamVac-Combi is conducting Phase 1/2 clinical studies, sponsored by the Gamaleya Research Institute of Epidemiology and Microbiology, which is part of the Russian Federation's Ministry of Health.

The inactivated rabies-vectored RS-CoV-2 S1 vaccine, CORAVAX, is adjuvanted with MPLA-AddaVax, a TLR4 agonist, and induces high levels of neutralizing antibodies, thereby generating a strong Th1-biased immune response. The Avaccc 101 vaccine candidate is designed to provide broad protection against SARS-CoV-1, SARS-CoV-2, and MERS-CoV.

Novavax's MERS investigational vaccine was paused at the preclinical stage.

Ralph Baric's lab at the University of North Carolina at Chapel Hill, in collaboration with the U.S. NIAID, negotiated an agreement to develop an MERS mRNA vaccine candidate.

CEPI provided $2.6 million in March 2025 to advance Uvax BioBio's RS vaccine candidate into preclinical trials.

MERS Outbreaks

The U.S. Centers for Disease Control and Prevention (CDC) describes MERS-CoV as a viral respiratory infection. The zoonotic source of this virus remains unknown. Since April 2012, when a patient with pneumonia died in a Jeddah hospital in Saudi Arabia, health authorities from 27 countries in six World Health Organization regions have reported 2,627 cases of MERS, including 946 deaths.

The U.S. CDC recommends MERS-CoV testing for persons within the United States who meet the MERS-CoV person-under-investigation criteria. In the United States, MERS-CoV testing declined from 2017 to 2023, and the clinical and epidemiologic criteria to guide U.S. testing were updated in 2024.

A study published in The Lancet in July 2024 highlighted the potential threat posed by RS-CoV, a member of the genus Merbecovirus, to global health. MERS-CoV circulates in dromedary camels in the Arabian Peninsula and occasionally causes human spillover infections. The emergence of MERS-CoV in camels and humans was preceded by a critical recombination event in which the ancestral receptor-binding module was replaced with a different merbecovirus lineage, thereby altering receptor usage. A key concern is the virus's ability to utilize diverse cell entry receptors, including ACE2.

The U.S. CDC's Emerging Infectious Diseases published a study (Volume 30, Number 3) in March 2024 that identified more than three clusters among animals from different areas of Nairobi, Kenya, and a 15% infection rate among slaughterhouse workers.

4 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Tuesday, July 8, 2025 - 13:20

Description:

MERS vaccine candidates protect people from severe infections related to interactions with camels and llamas.

Condition:

MERS

INO-4700 MERS-CoV Vaccine

INO-4700 Vaccine Description 2022

The INO-4700 MERS-CoV product is a DNA vaccine candidate, allowing rapid design and production in response to emerging infectious diseases. Underscoring the potential for rapid deployment of DNA vaccines, On November 17, 2022, the company discontinued the development following analyses of data from studies conducted by INOVIO and funded by CEPI.

INO-4700 (GLS-5300) is a DNA plasmid vaccine that expresses the MERS-CoV spike (S) glycoprotein and was co-developed by GeneOne Life Science Inc. and Inovio Pharmaceuticals.

The completed Phase 1 study, the INO-4700 vaccine candidate, was found well-tolerated and induced high antibody responses in 95% of subjects while generating broad-based T cell responses in nearly 90% of study participants. In addition, durable antibody responses to INO-4700 used in that trial were maintained through 60 weeks following dosing.

INOVIO confirmed on March 1, 2022, it had dosed and completed enrollment for the first part (dose-finding stage) of the Phase 2 trial (192 participants) of INO-4700. The trial is sponsored by INOVIO and fully funded by the CEPI and was being conducted at sites in Jordan, Lebanon, and Kenya, where MERS cases have been reported.

Pennslyvania-based INOVIO is a biotechnology company focused on rapidly bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and diseases associated with HPV. INOVIO is the first and only company to have clinically demonstrated that a DNA medicine can be delivered directly into cells in the body via a proprietary smart device to produce a robust and tolerable immune response.

INO-4700 Vaccine Indication

Human beta coronaviruses such as MERS were first identified in the mid-1960s. The best-known coronaviruses are MERS-CoV and Severe Acute Respiratory Syndrome (SARS-CoV) and the 2019 Novel Coronavirus (SARS-CoV-2). From 2012 until July 2, 2021, the ECDC reported 2,591 MERS-CoV cases and 940 associated fatalities.

The INO-4700 vaccine is indicated to prevent MERS, a deadly viral respiratory disease caused by MERS-CoV infection. To date, there is no specific treatment proven effective against this viral disease. Also, no vaccine has been licensed to prevent MERS-CoV infection thus far. Overall, vaccine candidates against MERS-CoV are mainly based upon the viral spike (S) protein due to its vital role in the viral infectivity, although several studies focused on other viral proteins such as the nucleocapsid (N) protein, envelope (E) protein, and non-structural protein 16 (NSP16) have also been reported.

The majority of the identified MERS-CoV cases are nosocomially acquired via direct close contact with infected patients (Chowell et al., 2015; Cauchemez et al., 2016), whereas cases of zoonotic transmission from dromedary camels to humans were reported primarily in Saudi Arabia, where human-camel interaction is more frequent.

INO-4700 Vaccine Dosage

INOVIO's DNA medicines deliver optimized plasmids directly into cells intramuscularly or intradermally using INOVIO's proprietary hand-held smart device called CELLECTRA®.

A July 24, 2019, Phase 1 first-in-human clinical trial. Initial findings from the trial were published in The Lancet Infectious Diseases. The study, conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center, evaluated a candidate DNA vaccine INO-4700.

Overall, for those receiving 0.6 mg of INO-4700, 88% demonstrated seroconversion after a 2 dose regimen at 0 and 8 weeks, while for those receiving a 3 dose regimen given at 0, 4, and 12 weeks, 84% seroconverted after 2 doses and 100% after 3 doses, as measured by a binding antibody assay against the full-length S protein (ELISA). Additionally, 92% of the vaccine recipients in both groups displayed the ability to neutralize the virus using a neutralization assay (EMC2012-Vero neutralization). Furthermore, robust T cell responses were observed in 60% of vaccine recipients after the 2 dose regimen and 84% in the 3 dose group (ELISpot assay). Interestingly, a single dose of 0.6 mg of INO-4700 intradermal vaccination resulted in a 74% binding antibody response rate and a 48% neutralization antibody response rate.

INO-4700 Vaccine News

August 4, 2021 - INOVIO announced that the company had dosed the initial Phase 2 trial subject in its quest to develop the first vaccine against the Middle East Respiratory Syndrome (MERS). INOVIO's Phase 2 trial is designed to evaluate INO-4700, its DNA vaccine candidate for the prevention of MERS, a disease in the coronavirus family for which there are no approved vaccines.

March 22, 2021 - This Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA™ 2000 device in healthy adult volunteers for the Middle East Respiratory Syndrome Coronavirus infection. This study is divided into 2 parts: Part 1- dose-finding stage and Part 2- dose expansion stage.

April 28, 2020 - INOVIO and GeneOne Life Science announced interim data through week 16 from a Phase 1/2a trial of DNA vaccine INO-4700 (also called GLS-5300) for MERS-CoV. Vaccine recipients demonstrated strong antibody and T cell immune responses after 2 or 3 doses with 0.6 mg of INO-4700. The vaccination regimen was well-tolerated with no vaccine-associated severe adverse events.

July 25, 2019 - Inovio Pharmaceuticals, Inc. announced positive results from the first-in-human trial of its vaccine against the MERS were published in The Lancet Infectious Diseases. This peer-reviewed article entitled, "Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: A phase 1, open-label, single-arm, dose-escalation trial," highlights clinical results of Inovio's collaborative vaccine study of INO-4700 (also called GLS-5300) against MERS delivered with the CELLECTRA® efficacy-enhancing device.

INO-4700 Vaccine Clinical Trials

Clinical Trial NCT04588428: Phase 2a Safety, Tolerability, and Immunogenicity of INO-4700 for MERS-CoV in 542 Healthy Volunteers. The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose-finding stage and Part 2- dose expansion stage. The multi-center Phase 2 trial is a randomized, double-blinded, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of INO-4700 administered with INOVIO's smart device, the CELLECTRA® 2000, in approximately 500 healthy adult volunteers. The study, which is sponsored by INOVIO and fully funded by the Coalition for Epidemic Preparedness Innovations, is being conducted at sites in Jordan and Lebanon where MERS cases have been reported.

Clinical Trial NCT03721718: Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers. This Phase I/IIa study will evaluate the safety, tolerability, and immunogenicity of GLS-5300 administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing 2 and 3-dose regimens.

Clinical Trial NCT02670187: Phase I, Open-Label Dose-Ranging Safety Study of GLS-5300 in 60 Healthy Volunteers. The Middle East Respiratory Syndrome Coronavirus (MERS CoV), a virus related to Severe Acute respiratory syndrome coronavirus (SARS CoV), was first recognized as a cause of severe pulmonary infection in 2012.

0 min read

Manufacturer:

Inovio Pharmaceuticals

Reviewer:

Robert Carlson, MD

Vaccine:

INO-4700 MERS-CoV Vaccine

Generic:

INO-4700

Clinical Trial:

https://clinicaltrials.gov/ct2/history/NCT04588428?V_4=View

Drug Class:

DNA Vaccine

Clinical Trial Phase I:

Phase I, Open-Label Dose-Ranging Safety Study of GLS-5300 in Healthy Volunteers

Clinical Trial Phase II:

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

Lab Test:

CDC

Condition:

MERS

Last Reviewed:

Friday, November 18, 2022 - 06:10

Status:

Candidate

Manufacturer Country ID:

Side Effects:

Phase 1 study

Jenvac Japanese Encephalitis Vaccine

JENVAC® Vaccine

JENVAC® is a single-dose inactivated Japanese Encephalitis (JE) Vaccine. This Vero cell-derived vaccine is prepared from an Indian strain (Kolar- 821564XY) of the JE virus. JENVAC has been developed in collaboration with India's National Institute of Virology. It is a safe and highly effective vaccine that protects against all known strains of Japanese Encephalitis.

JENVAC® is a safe and highly effective vaccine that protects against all the known strains of JE. World Health Organization showed that 6,383 cases of JE were reported in India between 2018 and 2022.

Bharat Biotech is a pioneering biotechnology company based in India known for its world-class R&D and manufacturing capabilities.

JENVAC Indication

Japanese Encephalitis is the most common cause of viral Encephalitis in Asia. JE is a mosquito-borne flavivirus and belongs to the same genus as dengue, yellow fever, and West Nile viruses. JE is transmitted to humans through bites from infected mosquitoes of the Culex species. Most JE infections are mild (fever and headache) or without apparent symptoms, but approximately 1 in 250 infections result in severe clinical illness. Severe disease is characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, paralysis, and ultimately death.

JE's case-fatality rate can be as high as 30% among those with disease symptoms. Of those who survive, 20%–30% suffer permanent intellectual, behavioral, or neurological sequelae such as paralysis, recurrent seizures, or the inability to speak. There is no antiviral treatment for patients with JE. Treatment is supportive to relieve symptoms and stabilize the patient.

JENVAC Dosage

Data from a 2-dose study shows that a single dose of JENVAC is sufficient to elicit the immune response as the subjects who received a single dose were 98.67% sero-protected, and the 4-fold sero-conversion was at 93.14% for the ≥1 year to ≤50 years age group. JENVAC vaccine is administered intramuscularly into the deltoid region of the upper arm for adults and the anterolateral regarea of the thigh for children. As per the Recommended immunization schedule (2018-19), the JE vaccine should be administered at 12 months and 13 months. Infants younger than two months should not be administered JE the vaccine; People who have had a life-threatening allergic reaction to the JE vaccine or any ingredient in the vaccine.

JENVAC Adverse Events

The most common adverse events noted were pain, swelling, or redness where the shot was given, headache and muscle aches (mostly in adults), and low fever (mainly in children). Serious side effects from the JE vaccine are very infrequent.

JENVAC Vaccine News

February 2024 - India's government will vaccinate over 25 lakh children in four districts, including Indore, Bhopal, Narmadapuram, and Sagar, beginning February 27, 2024.

August 1, 2022 - Japanese Encephalitis has claimed four more lives in Assam, India, taking the death toll to 52.

0 min read

Manufacturer:

Bharat Biotech

Reviewer:

Robert Carlson, MD

Vaccine:

Jenvac Japanese Encephalitis Vaccine

VIS:

PDF

Availability:

Not licensed for use in the US

Generic:

JE Vaccine

Drug Class:

Vaccine

Find Price:

Discounts

Clinical Trial Phase II:

A Phase II/III, Randomized, Single Blinded, Active Controlled Study to Evaluate the Immunogenicity and Safety of inactivated Jap

Condition:

Japanese Encephalitis

Last Reviewed:

Saturday, February 24, 2024 - 05:50

Brand:

JENVAC

Status:

Approved

Manufacturer Country ID:

Kosher:

Yes

Halal:

Yes

Countries:

India

Rate Vaccine:

EH65UOFx

Japanese Encephalitis Vaccines

Japanese Encephalitis Vaccines 2025

Japanese encephalitis virus (JEV) protective vaccines have been found safe and effective. They are approved for use in the United States as of March 14, 2025, according to the U.S. Centers for Disease Control and Prevention (CDC). The CDC's Advisory Committee on Immunization Practices (ACIP) recommends the JE vaccine for people traveling to a JE-endemic country. The CDC says to consider the JE vaccine (IXIARO) for shorter-term (<1 month) travelers based on planned travel duration, season, location, activities, and accommodation. In addition, vaccination should be considered for travelers going to JE-endemic areas who are uncertain of specific destinations, activities, or travel duration.

As of 2025, the World Health Organization (WHO) data represent Japanese Encephalitis vaccination coverage reported by countries through the WHO/UNICEF.

Japanese Encephalitis Vaccines Authorized

A JE vaccine was first licensed in the United States at the end of 1999. There are three types of JEV vaccines: inactivated Vero cell-derived, live attenuated, and live recombinant (chimeric) vaccines. In June 2009, the CDC's ACIP approved recommendations for the use of JE-VC in adults and for an adult booster dose. In May 2013, the U.S. FDA approved JE-VC for children aged two months through 16 years. In April 2018, FDA approval for a booster dose was expanded to include the pediatric age group.

Valneva SE IXIARO is an inactivated, adsorbed vaccine derived from Vero cell culture. It is available at travel clinics and pharmacies in the U.S. and is recommended by the CDC.

JENVAC is an inactivated vero cell-derived vaccine prepared from an Indian Kolar strain of the Japanese encephalitis virus. Other JE vaccines are manufactured and used in different countries, but are not licensed in the U.S.

IMOJEV® (JE-CV, ChimeriVax™-JE) is a recombinant chimeric virus vaccine developed using the Yellow fever virus (YFV) vaccine vector YFV17. It replaces the cDNA encoding the envelope proteins of YFV with that of an attenuated JEV strain SA14-14-. Waning immunity in a small proportion of individuals suggests that booster doses may benefit high-risk travelers vaccinated more than 5 years ago.

Japanese Encephalitis Vaccine Candidates

A study suggests that CD.JEVAX® can be a viable option for booster vaccination in JE prevention programs. (TCTR ID: TCTR20221102003).

SK bioscience announced in February 2025 the commencement of global Phase 1/2 clinical trials for its mRNA-based Japanese encephalitis vaccine candidate, GBP56. This project is based on a CEPI agreement, under which CEPI committed $40 million in initial funding. An additional $100 million in funding could be available later to support late-stage trials/licensure.

Japanese Encephalitis Outbreaks

Japanese Encephalitis outbreaks continue in March 2025.

3 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Thursday, December 18, 2025 - 10:05

Description:

Japanese Encephalitis vaccine is U.S. FDA authorized

Condition:

Japanese Encephalitis

Chikungunya Vaccines

Chikungunya Vaccines December 2025

Chikungunya vaccines have been commercially available since 2023 and are approved in various countries, including the United States, as of December 2025. Like many vaccines, Chikungunya virus (CHIKV) vaccine technologies, such as live-attenuated virus vaccines, inactivated viral vaccines, recombinant viral vaccines, chimeric alphavirus candidates, DNA vaccines, and virus-like particles, focus on optimizing the balance between efficacy, immunogenicity, and safety, according to the World Health Organization (WHO).

Chikungunya Vaccine Approved and Available

The U.S. CDC's Advisory Committee on Immunization Practices (ACIP) issued recommendations for the CHIKV vaccine in April 2025, which were adopted by the HHS Secretary on May 13, 2025. As of May 21, 2025, these recommendations are the official guidelines of the CDC.

In the United Kingdom, IXCHIQ® and Vimkunya® vaccines have been reviewed by the Joint Committee on Vaccination and Immunization as of August 7, 2025, and guidance will be drafted for the UK Health Security Agency's green book,' Immunization against infectious disease. Health professionals offering these vaccines must ensure they are adequately informed on their use.

The IXCHIQ chikungunya vaccine from Valneva SE was approved in the U.S. in 2023 and in Canada, Europe, the United Kingdom, and Brazil. On August 22, 2025, it was removed from the U.S. market.

VIMKUNYA® is a virus-like particle vaccine produced by Bavarian Nordic A/S. It was approved in the U.S. and Europe in 2025. It became commercially available at travel clinics and pharmacies in March 2025.

Chikungunya Vaccine Candidates 2025

The WHO states that several advanced chikungunya vaccine candidates are either undergoing or have already completed regulatory review.

Bharat Biotech International Ltd.'s Chikungunya vaccine candidate, BBV87, is an inactivated whole-virion vaccine based on a strain derived from an East, Central, and South African genotype.

Moderna's mRNA-1944 vaccine candidate encodes a fully human IgG antibody, initially isolated from the B cells of a patient with a prior history of dengue. A study published in March 2025 concluded that the results from both mouse and rhesus macaque models indicate that the vaccine could be a candidate for clinical use against CHIKV.

CD8+ T cell CHIKV Adaptive Vaccine candidate. Including the ligandome into the vaccine construct will require the selection of eight to twelve peptides from the CHIKV peptide set (ligandome), all of which meet several specific criteria. In efficacy studies, the following will then need to be completed.

The Access to Advanced Health Institute received an $18 million award from the National Institutes of Health to develop a temperature-stable, single-dose vaccine candidate for the chikungunya virus. The vaccine uses an innovative RNA platform technology.

A CHIKV vaccine candidate based on baculovirus displaying the chikungunya E1-E2 envelope confers protection against clinical challenges in mice. C57BL/6 mice were immunized with non-adjuvanted recombinant baculovirus-induced IgG antibodies against E2, with a predominant IgG2c subtype, neutralizing antibodies, and a specific IFN-γ CD8+ T-cell response. A second dose significantly boosted the antibody response.

CHIKV mRNA vaccines study - the results from both mouse and rhesus macaque models indicate that the vaccine could be a candidate for clinical use against CHIKV. Based on the favorable protective effects described in March 2025, 'we consider both mCV-1 and mCV-2 to be potential candidate vaccines for further evaluation in subsequent phase I studies.'

Chikungunya Infections in Infants

This study describes the epidemiological characteristics, clinical presentation, and evolution of unvaccinated patients with CHIKV admitted to the Pediatric Emergency Department in Asunción, Paraguay, during the 2023 epidemic. Results showed a predominance of febrile infants with altered PAT who presented septic shock within the first 24 hours of hospital admission, 15% of patients with seizures, and 2.5% who died.

Chikungunya Virus Mutations

A study published in May 2025 stated the ongoing large outbreak in Sri Lanka is due to the Indian Ocean lineage and the E1:K211E/E2:V264A sublineage of the Chikungunya virus, which has acquired specific, previously uncharacterized mutations. The impact of these mutations on vaccine effectiveness has not been disclosed.

Chikungunya Outbreaks

As of 2025, millions of people live in areas where Chikungunya is endemic. Chikungunya outbreak news is posted at this link.

4 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Saturday, December 13, 2025 - 11:25

Description:

Chikungunya preventive vaccines have been approved in the United States for 2025

Condition:

Chikungunya

Dengue Vaccines

Dengue Vaccines September 2025

According to the World Health Organization (WHO), in 2025, Dengue is a vaccine-preventable disease, with approved vaccines available. As of September 2025, the U.S. Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), the Pan American Health Organization (PAHO), the European Medicines Agency (EMA), Australia's Technical Advisory Group on Immunisation, and Brazil's National Health Surveillance Agency (ANVISA) recommend dengue vaccination for specific individuals living in or visiting dengue-risk areas, such as Puerto Rico and Brazil. The UK Health Security Agency published updated dengue vaccination guidance in the 'Green Book' (Chapter 15a) in October 2024.

Dengvaxia® is a live attenuated tetravalent chimeric vaccine approved by the U.S. FDA and various countries. Dengvaxia is no longer offered in the U.S., except for children in Puerto Rico, where Dengue fever has become endemic.

QDENGA® dengue vaccine is approved or authorized in various countries and does not require pre-admission testing. As of July 2025, the U.S. FDA has not approved this vaccine.

Dengue Vaccine Candidates

As of September 2025, clinical trials for the dengue vaccine candidate are recruiting new participants. A review, published in 2025, highlights the challenges in developing a third-generation dengue vaccine. A study published in April 2025 found that the antibody avidity index is essential for characterizing protective DENV immune responses.

Merck's MOBILIZE-1 Phase 3 clinical trial is being initiated for V181, a live attenuated quadrivalent dengue vaccine candidate. As of June 12, 2025, the study will evaluate a single dose of V181 for the prevention of dengue disease caused by any of the four serotypes of the dengue virus, regardless of previous exposure.

Panacea Biotech, in collaboration with the Indian Council of Medical Research (ICMR), is developing the DengiAll dengue vaccine. The tetravalent dengue vaccine strain (TV003/TV005), initially created by the U.S. National Institutes of Health, has shown promising results in preclinical and clinical trials worldwide. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results. With 3 years of follow-up, the single-dose tetravalent dengue vaccine, TV005, was well tolerated and immunogenic for all four serotypes in young children to adults, including individuals with no previous dengue exposure. Panacea Biotec has worked extensively on these strains to create a full-fledged vaccine formulation and holds a process patent. In August 2024, ICMR and Panacea announced the launch of a Phase 3 clinical trial in India.

Butantan Institute's Butantan-DV tetravalent dengue vaccine candidate demonstrated 67-79% efficacy in preventing the disease in Brazil, according to a Phase 3 clinical study, which is ongoing through 2024. On December 16, 2024, the Company submitted the proposal to Anvisa for approval. The institute can produce 100 million doses if approved over the next three years. On February 1, 2024, an Original Article concluded that a clinical study found a single dose of Butantan-DV prevented symptomatic DENV-1 and DENV-2, regardless of dengue serostatus at baseline, through 2 years of follow-up. Butantan-DV is derived from a technology licensed from the U.S. National Institutes of Health (NIH) in 2009. Under the collaboration agreement announced in December 2018, Merck and Instituto Butantan are sharing clinical study data.

Serum Institute of India's tetravalent dengue vaccine live candidate, Dengusiil, is conducting phase 2 clinical research in 2024. A previous Phase 1 study concluded that a single dose of Dengusiil was safe and well-tolerated in adults, and highly immunogenic, with trivalent or tetravalent seroconversion and seropositivity in most participants (69%).

National Institute of Allergy and Infectious Diseases - TetraVax-DV T005 (rDEN3Δ30/31-7164) is a live attenuated tetravalent vaccine. A Phase 2 clinical trial revealed that, with three years of follow-up, a single dose of TV005 was well-tolerated and immunogenic for all four serotypes in young children and adults, including individuals with no prior dengue exposure. Results of a phase 2 study of TV005 in Bangladesh, published in 2024, reported the waning of antibody titers in children aged 1–4 years who were seronegative at the time of vaccination. Only 22–28% of children in this age group remained seropositive for DENV-1, DENV-3, and DENV-4 after three years of follow-up, compared with 69% seropositivity for DENV-2.

TetraVax-DV-TV003 (V180) is a live-attenuated, recombinant, tetravalent investigational dengue vaccine, currently undergoing a Phase 3 clinical trial in Brazil. Dr. Stephen Whitehead's laboratory developed the vaccine. Merck recently completed a phase 1 study (V180-001).

The DV1-DV4 vaccine candidate is transitioning into a human clinical study. This new vaccine construct, which comprises Nature's gene-chip peptides bound to a quantum cluster gold nanoparticle delivery system, demonstrated an excellent safety profile in a repeat-dose Good Laboratory Practice (GLP)- grade toxicology study using a standard industry model.

Àvida Biotech's novel oral vaccine candidate for Dengue does not require cold transport or storage and has completed proof of concept in a mouse model. Additionally, the University of Buffalo's Center for Integrated Global Biomedical Sciences will provide expertise in preclinical drug development.

K.M. Biologics' KD-382 vaccine is a live-attenuated tetravalent dengue candidate in Phase 1 clinical trials. A single dose is expected to be effective against all four serotypes. Additionally, this live attenuated virus vaccine is expected to induce neutralizing antibodies and cellular immunity, similar to that caused by natural infection.

Emergex PepGNP-Dengue DengueTcP™, Its Novel T Cell-Priming Immune Set-Point Candidate, uses 100% synthetic vaccines to 'prime' naive CD8+ T-Cells to generate virus-specific CTL (CD8+ Cytotoxic T Lymphocyte cells) to kill infected cells before productive viral infection, thus preventing viral replication and disease in the vaccinated person. naNO-DENGUE: A Phase-I study of a nanoparticle-based peptide vaccine against Dengue virus.

CodaVax-DENV is a next-generation, tetravalent, live-attenuated dengue vaccine candidate under development by Codagenix Inc. The Company's vaccine design platform has enabled the precise and rational attenuation of contemporary serotypes of all four dengue virus strains through selective codon deoptimization. With this approach, Codagenix can rationally balance all four virus serotypes to produce a safe and highly immunogenic vaccine. On October 24, 2023, Codagenic announced that the U.S. Department of Defense awarded the Company $5.88 million to advance the development of its CodaVax-DENV program. The funding supports good manufacturing practices of drug substances and tetravalent drug products for a Phase 1 study and a first-in-human Phase 1 safety and immunogenicity trial. This award complements a $4.4 million Department of Defense (DoD) award granted in 2022.

Indian Immunologicals Limited (IIL) anticipates launching its dengue fever vaccine commercially by 2026. IIL's Managing Director, K. Anand Kumar, stated on August 20, 2024, that the vaccine's early-stage trials involving approximately 90 individuals aged 18-50 did not demonstrate any adverse effects. The U.S. National Institute of Health provided IIL with the dengue virus required to develop the vaccine. ILI is a subsidiary of the National Dairy Development Board.

Dengue Monoclonal Antibody Therapy

Dengushield (VIS513) is a humanized monoclonal antibody (mAb), not a vaccine, that delivers passive immunization and is evaluated in phase 2 clinical trials to treat Dengue. VIS513 is a highly potent inhibitor of all four types of dengue viruses, both in vitro and in preclinical animal models. VIS513 was licensed to the Serum Institute of India Pvt. Ltd (SIIPL) for development and commercialization may cost 5,000 to 10,000 rupees per dose. SIIPL funded a Phase 1 study announced in February 2024, and the VIS513 mAb was found to be safe and well-tolerated, with a dose-proportionate increase in pharmacokinetic exposure. A phase 3 study is ongoing.

AbViro LLC (Janssen, LP) AV-1 dengue mAb candidate (JNJ-64281802) is conducting a Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Safety and Efficacy of Three Dose Levels in Healthy Adults Challenged With a Controlled Human Infection Strain of DENV-3. Before or after AV-1 dosing, each volunteer will receive an attenuated (weakened) dengue virus injection. If AV-1 shows promising results in this clinical trial, researchers may pursue further clinical evaluations of its safety and efficacy against the dengue virus. In earlier studies using this challenge virus, most volunteers developed a rash, and some had other mild dengue symptoms, such as joint and muscle pain or headache. None of the volunteers developed dengue fever or severe Dengue.

Dengue Outbreaks 2025

Visit Vax-Before-Travel for the latest travel alerts regarding dengue outbreaks in June 2025.

8 min read

Reviewer:

Robert Carlson, MD

Last Reviewed:

Friday, September 5, 2025 - 13:40

Description:

Dengue vaccines are approved by various countries in September 2025.

Condition:

Dengue

VTP-500 MERS Vaccine

VTP-500 MERS Vaccine Clinical Trials, Dosage, Indication, Side Effects

Barinthus Biotherapeutics plc VTP-500 (ChAdOx1) vaccine candidate prevents the Middle East Respiratory Syndrome Coronavirus (MERS) Coronaviruses (CoV). The ChAdOx1 MERS vaccine candidate contains the replication-deficient simian adenovirus vector ChAdOx1, containing the MERS Spike protein antigen. VTP-500 MERS vaccine utilizes the ChAdOx1 virus platform to encode MERS coronavirus spike protein to induce T cells and antibodies that block virus-host cell receptor binding and fusion or neutralize virus infection.

The patented Vaccitech adenovirus vectors are known as chimpanzee adenovirus Oxford 1 and 2 (ChAdOx1 and ChAdOx2) and are in the group E simian adenovirus family, similar to the widely-studied chimpanzee adenovirus 63. These viruses have been engineered to be replication-deficient and manufactured in well-established HEK293 cell lines containing the adenoviral E1 gene. Vaccitech licensed the needed patents from Oxford University to advance its programs. The ChAdOx1 vector patent was granted in the US and the EU, and the MVA-NP+M1 patent was granted in the EU and is pending in the US.

The University of Oxford’s Jenner Institute, in collaboration with The King Abdullah International Medical Research Centre (KAIMRC), announced on December 20, 2019, that it has started a Phase I clinical trial in the Kingdom of Saudi Arabia (KSA) for a vaccine against the MERS-CoV. VTP-500 has completed Phase I clinical trials in Britain and Saudi Arabia, and the University of Oxford is now extending the Phase Ib trial in the UK to assess vaccination of older adults.

On December 21, 2023, Barinthus Bio announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of a vaccine candidate known as VTP-500 to prevent MERS. The project will see CEPI, Barinthus Bio, and the University of Oxford take the MERS vaccine candidate from early development through Phase II clinical trials and, if the Phase II clinical trials are successful, develop an investigational ready reserve of 100,000 vaccines. Barinthus Bio will receive $34.8m in addition to previous funds that were committed to the University of Oxford and the CEPI will invest up to $47m to develop and stockpile the ready reserve of the MERS vaccine candidate. The development partners are committed to enabling equitable access to VTP-500 in line with CEPI’s Equitable Access Policy. Due to VTP-500’s potential to significantly address MERS outbreaks, the European Medicines Agency (EMA) confirmed support for the program through the PRIME designation.

Oxford, England-based Barinthus Biotherapeutics plc (Vaccitech) (NASDAQ: BRNS) is an immunotherapy and vaccine company. The Company’s proprietary platform comprises proprietary modified simian adenoviral vectors, known as ChAdOx1 and ChAdOx2, and the well-validated Modified Vaccinia Ankara, or MVA, boost vector, both with demonstrable tolerability profiles and without the ability to replicate in humans.

VTP-500 MERS Vaccine Indication

VTP-500 (ChAdOx1) vaccine candidate is designed to protect people against MERS-CoV.

VTP-500 MERS Vaccine News

December 21, 2023 - “Coronaviruses are one of the most urgent infectious disease threats the world faces, so it’s vital that we get on with developing medical defenses against this particularly deadly one – MERS,” said Dr. Richard Hatchett, CEPI’s Chief Executive Officer. “With this project, we will both advance scientific understanding of the coronavirus family as a whole and, at the same time, bolster humanity’s ability to respond to an ever-present epidemic threat.”

September 18, 2023 - A vaccine to protect people against MERS was launched in September 2023. This is the third Phase I clinical trial of the ChAdOx1 MERS vaccine.

August 12, 2021 - Vaccitech plc provided an overview of the Company’s recent corporate developments.

April 29, 2021 - Vaccitech plc announced the pricing of its initial public offering in the United States for total gross proceeds of $110.5 million.

March 22, 2021 - Vaccitech Ltd. announces Joseph Scheeren, PharmD, as an independent director to its Board of Directors.

August 21, 2020 - CEPI, Oxford University, and Janssen have entered into a collaboration worth up to $19M to progress the vaccine through Phase 2 studies and establish a human vaccine stockpile with the University.

June 10, 2020 - RESEARCH ARTICLE: A single dose of ChAdOx1 MERS provides protective immunity in rhesus macaques.

April 17, 2020 - NIH press release: Investigational chimp adenovirus MERS-CoV vaccine protects monkeys. Vaccine neutralizes multiple MERS-CoV strains.

December 20, 2019 - Vaccitech’s partner, the University of Oxford’s Jenner Institute, in collaboration with The King Abdullah International Medical Research Centre (KAIMRC), announced that it had started a Phase I clinical trial in the Kingdom of Saudi Arabia (KSA) for a vaccine against the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). Vaccitech retains commercial rights to this vaccine. The trial will be the first Phase I clinical trial ever conducted in the KSA and will provide valuable clinical data. The trial is a collaboration between the Jenner Institute and the King Abdullah International Medical Research Center (KAIMRC), funded by the Department of Health and Social Care.

November 8, 2019 - Study: Humoral Immunogenicity and Efficacy of a Single Dose of ChAdOx1 MERS Vaccine Candidate in Dromedary Camels.The vaccination reduced virus shedding and nasal discharge (p = 0.0059 and p = 0.0274). The vaccine enhanced antibody responses in seropositive camels; these camels had a higher average age than seronegative. Older seronegative camels responded more strongly to vaccination than younger animals, and neutralizing antibodies were detected in nasal swabs.

VTP-500 Clinical Trials

Clinical Trial NCT04170829: A Clinical Trial to Determine the Safety and Immunogenicity of Healthy Candidate MERS-CoV Vaccine. This research was funded by the Department of Health and Social Care (project number 16/107/01) as part of the UK Vaccine Network (UKVN), a UK Aid program to develop vaccines for diseases with epidemic potential in low and middle-income countries.

Findings: Between Dec 17, 2019, and June 1, 2020, 24 participants were enrolled (six to the low-dose, nine to the intermediate-dose, and nine to the high-dose group) and received a dose; 23 were available for follow-up at six months. The one dose of ChAdOx1 MERS vaccine was well tolerated with no serious adverse event reported during the six months of follow-up. Most adverse events were mild (67, 74%) and moderate (17, 19%). Six (7%) severe adverse events were reported by two participants in the intermediate-dose group (two feverish, two headache, one joint pain, and one muscle pain). Pain at the injection site was the most common local and overall adverse event, reported by 15 (63%) of the 24 participants. The most common systemic adverse event was headache, reported by 14 (58%), followed by muscle pain reported by 13 (54%). The vaccine-induced antibody and T cell immune responses in all volunteers; antibodies peaked at day 28, and T cell responses peaked at day 14 and continued until the end of follow-up at six months.

Clinical Trial NCT03399578: Suspended (The SARS-CoV-2 pandemic delayed recruitment but also provided an opportunity to apply findings from the rapid development of a ChAdOx1-vectored vaccine against SARS-CoV-2 to the further development of the MERS vaccine).

Findings: Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at six months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 1010 viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed unrelated to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered possibly, probably, or related to ChAdOx1 MERS were predominantly mild and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001). Laboratory adverse events considered at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralizing antibodies against live MERS-CoV was observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralization in a pseudotyped virus neutralization assay.

0 min read

Manufacturer:

Barinthus Biotherapeutics plc

Reviewer:

Robert Carlson, MD

Vaccine:

VTP-500 MERS Vaccine

Availability:

TBD

Generic:

VTP-500

Drug Class: