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children vaccinations

Africa Commits Catch-Up Vaccinations for Children

Yellow fever, measles, polio under vaccinated African children
February 27, 2023
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Moderna, Inc. and Merck recently announced that mRNA-4157/V940, an investigational personalized mRNA cancer vaccine, in combination with KEYTRUDA, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with high-risk melanoma following complete resection.

Personalized cancer vaccines are designed to prime the immune system so that a patient can generate a tailored antitumor response specific to their tumor mutation signature. 

The FDA granted Breakthrough Therapy Designation based on positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial.

"The FDA's Breakthrough Designation for mRNA-4157/V940 in combination with KEYTRUDA reflects the excitement that we have for the potential promise of individualized cancer treatments," said Stephen Hoge, M.D., Moderna's President, in a press release on February 22, 2023.

"mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers."

"We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities."

mRNA-4157/V940 is a novel investigational mRNA-based personalized cancer vaccine consisting of a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced based on the unique mutational signature of the patient's tumor. Upon administration into the body, the algorithmically derived and mRNA-encoded neoantigen sequences are endogenously translated and undergo natural cellular antigen processing and presentation, a key step in adaptive immunity.

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

The FDA's Breakthrough Therapy Designation is granted to expedite the development and review of drugs that are intended to treat a serious condition, and when preliminary clinical evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint.

This news is essential since the rates of melanoma have been rising over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.

In the U.S., skin cancer is one of the most common types of cancer diagnosed, and melanoma accounts for a large majority of skin cancer deaths.

Vaccine Treats: 
Skin Cancer
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Image Caption: 
U.S. CDC Skin Cancer 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
New Jersey
Paraguay map

Paraguay's Chikungunya Outbreak Intensifies

Chikungunya vaccine seeks U.S. approval
February 26, 2023
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In a review article recently published in Vaccines Journal referenced over 25 studies and discussed multiple injection delivery methods, including PharmaJet's needle-free precision delivery systems.

This study found that needle-free delivery enhanced the clinical performance of DNA-based vaccines.

Currently, 250 vaccine programs are invested in DNA vaccines and therapeutics because of their potential benefits.

"We are enthused to see that pre-clinical results have translated into more effective clinical responses in human trials," said Chris Cappello, President and CEO of PharmaJet, in a press release on February 23, 2023. 

"We currently have eighty-three studies ongoing with novel pharmaceuticals focusing on nucleic acid technology and other new vaccine technology platforms."

"We believe that our precision delivery devices have the potential to increase the performance and therefore the probability of regulatory success of many of these candidate vaccines."

Several DNA candidate vaccines in combination with PharmaJet devices are in development, including for a COVID-19 bivalent booster, HIV, Zika, influenza, poxvirus, hantavirus, and dengue infections.

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Image Caption: 
PharmaJet Systems Feb. 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Denver
Bacterial vaccine funding

£1 Million Supports Bacterial Vaccine Development

Bacterial vaccines fight against antimicrobial resistance
February 22, 2023
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LinKinVax today announced the interim results of a double-blind, Phase I clinical trial evaluating CD40.HIVRI.Env, a preventive HIV vaccine candidate.

The ANRS VRI06 study's initial results, published on February 22, 2023, show that the vaccine candidate was safe and induced an early, significant, and sustained immune response.

The vaccine yielded high levels of antibodies directed against the HIV envelope: 

  • 80-100% at Week 6,
  • 100% at Week 26 in all groups (0.3, 1, and 3 mg).
  • These levels remained stable or dropped slightly until Week 48.
  • Antibodies targeting a specific area of the HIV envelope (V1/V2 region) were also produced.

Furthermore, at Week 26, neutralizing antibodies were detected in 50% of subjects in the 0.3 mg group and 100% of subjects in the other two groups.

The observed counts of CD4+ T cells targeting specifically the HIV envelope protein produced after the vaccination remained stable until Week 48.

Prof. Yves Lévy, Executive Director of the Vaccine Research Institute and CMSO of LinKinVax, commented in a press release, "The immune response profile generated by this vaccine (antibody response and activation of polyfunctional CD4+ T cells) was the one associated with a reduced risk of HIV infection in the RV144 trial."

"However.... the efficacy of this vaccine will only be evaluated in the Phase II/III studies."

LinKinVax's vaccine platform is built around a humanized monoclonal antibody, which is merged with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells, DC, which play a key role in stimulating the immune system. 

André-Jacques Auberton-Hervé, Co-founder and CEO of LinKinVax, added, "We are pleased with these very promising immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and confirm its safety."

"This important milestone paves the way for the upcoming Phase II/III clinical studies that we will conduct once the final Phase I results has been obtained."

"These studies will aim to demonstrate the efficacy of the vaccine, the "Everest of vaccine strategies," which has been the elusive goal of HIV research for the past 40 years."

Other HIV vaccine development news is posted at Precision Vaccinations.

Vaccine Treats: 
HIV
Image: 
Image Caption: 
by Gerd Altmann
Live Blog Update Author: 
Don Hackett
Location Tags: 
Paris
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Icosavax, Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IVX-A12, a bivalent respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) virus-like particle (VLP) vaccine candidate, in older adults 60 years of age and above.

Niranjan Kanesa-thasan, Chief Medical Officer of Icosavax, commented in a press release on February 21, 2023, "IVX-A12 is differentiated as the most advanced vaccine candidate against these two leading causes of pneumonia in older adults."

In October 2022, Icosavax initiated a Phase 1, randomized, observer-blinded, placebo-controlled, multicenter study of IVX-A12, with and without CSL Seqirus' proprietary adjuvant MF59®, in up to 120 healthy older adults aged 60 to 75 years.

Icosavax anticipates announcing topline interim results from this Phase 1 trial in mid-2023, with subjects after that followed through 12 months after vaccination.

The company plans to initiate a Phase 2 trial for IVX-A12 in the second half of 2023.

According to the FDA, Fast Track is a process designed to facilitate the development and expedite the review of investigational drugs to treat serious conditions and fulfill an unmet medical need. An investigational drug that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.

As of February 21, 2023, the FDA has not approved any RSV vaccine candidates conducting late-stage studies. Furthermore, the FDA has approved and is reviewing RSV monoclonal antibody therapies.

Vaccine Treats: 
Respiratory Syncytial Virus (RSV)
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Image Caption: 
by Vlad Vasnetsov
Live Blog Update Author: 
Don Hackett
Location Tags: 
Seattle
0 min read

Vaxcyte, Inc. announced today that the U.S. Food and Drug Administration (FDA) had cleared the Company's infant Investigational New Drug (IND) application for VAX-24, its lead, 24-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).

Vaxcyte stated it plans to initiate the infant Phase 2 study in the second quarter of 2023, with data expected by 2025.

The infant study design will include a primary immunization series consisting of three doses followed by a subsequent booster dose.

"The clearance of the VAX-24 infant IND application marks an important step in expanding the development of our lead, broad-spectrum PCV candidate in this important and vulnerable population," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release on February 21, 2023.

"Based on the positive data from our Phase 1/2 proof-of-concept study in adults, we believe VAX-24 has the potential to deliver a best-in-class profile with broader coverage and better immune responses relative to the standard-of-care for both the adult and pediatric populations."

"We remain focused on advancing our VAX-24 clinical programs and look forward to the anticipated initiation of the infant study and announcement of the topline results from our Phase 2 study in adults aged 65 and older in the second quarter of this year."

Despite the effectiveness of current vaccines, IPD, which includes meningitis and bacteremia, remains persistent in the first years of life and is a leading cause of invasive disease in children two years of age and under.

The burden of disease in the pediatric population underscores the need for a broader-spectrum vaccine.

Precision Vaccinations post additional pneumococcal disease vaccine and candidates news.

Vaccine Treats: 
Pneumococcal
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Image Caption: 
by Smith P.
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
San Carlos
Vaccine: 
Pneumococcal Vaccines
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Tonix Pharmaceuticals Holding Corp. recently announced that it is obtaining an exclusive license from Columbia University in New York for the development of a portfolio of fully human (TNX-3600) and murine (TNX-4100) monoclonal antibodies (mAbs) for the treatment or prevention of SARS-CoV-2 infection.

The Company believes that murine mAbs, such as TNX-4100, have the potential to generate high-affinity antibodies that recognize different epitopes on the SARS-CoV-2 spike protein.

This is because mice have a different repertoire of antibodies than humans.

The technology for generating antibodies optimizes the selection of appropriate B cells by the timing of immunization, harvesting approach, and screening platform.

Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, commented in a press release on February 13, 2023, "Immunocompromised individuals, including organ transplant recipients, are at increased risk of severe COVID-19 and poor clinical outcomes."

"We believe there is a need for second-generation mAb treatments and prophylactics to protect this population."

Although five mAb products containing seven distinct mAbs received emergency use authorization from the U.S. Food and Drug Administration for either treatment or prevention of COVID-19, none have remained useful or available in the U.S. since January 26, 2023.

Other mAbs news is posted at Coronavirus Today.

Vaccine Treats: 
COVID-19
Image: 
Image Caption: 
by Brian Merrill
Live Blog Update Author: 
Don Hackett
Location Tags: 
New Jersey
Vaccine: 
Anti-SARS-CoV-2 Monoclonal Antibodies

Chlamydia Vaccines

Chlamydia Vaccines 2025

Researchers are progressing with Chlamydia vaccine candidates in clinical trials in March 2025. However, the U.S. Food and Drug Administration (FDA), the United Kingdom, and the European Medicines Agency (EMA) have not approved a vaccine to prevent chlamydia infections, a common bacterial sexually transmitted pathogen. The Annals of Family Medicine journal published a study (23 (2) 136-144) on March 24, 2025, concluding that many women do not receive guideline-adherent treatment in primary care settings. For example, the time to treat chlamydia was longer for patients aged 50-59 years (time ratio relative to those aged 20-29 years = 1.61; 95% CI, 1.12-2.30).

Chlamydia Vaccine Candidates

The U.S. FDA has granted fast-track designation to Sanofi's mRNA vaccine candidate for preventing chlamydia infection. The decision announced on March 26, 2025, was based on the potential of the vaccine candidate to address a serious condition and an unmet public health need. Sanofi's multi-antigen chlamydia vaccine candidate proceeded to Phase 1/2 in 2024.

Statens Serum Institut's adjuvanted vaccine candidate (CTH522) has completed clinical Phase Ia and Ib testing in The Lancet Infectious Diseases and Research Square. The vaccine antigen CTH522 is a recombinant, engineered version of the C. trachomatis major outer membrane protein, comprising heterologous immunorepeats from four genital C. trachomatis serovars (D, E, F, and G). In April 2024, CTH522, with CAF01 or CAF09b, was found safe and immunogenic in the EU Horizon Program TRACVAC-funded phase 1 clinical trial. 85 μg CTH522-CAF01 induced robust serum IgG binding titers. Intradermal vaccination conferred systemic IgG neutralization breadth, and topical ocular administration increased ocular IgA formation. 

LinKinVax, linked to the Vaccine Research Institute, is conducting pre-clinical research on the Anti.CD40.chlamydia vaccine candidate.

The UNC Chlamydia Vaccine Initiative is funded by the National Institute of Allergy and Infectious Diseases to accelerate the development of a novel vaccine that prevents CT ascension in the female genital tract, eliminating CT-associated PID and infertility.

A safe and effective multi-epitope vaccine was designed using an immunoinformatics approach to prevent C. pneumoniae infection. As of September 12, 2023, the study's results provided novel strategies for developing C. pneumoniae vaccines; however, future experimental validation of this vaccine candidate is needed to determine its efficacy, effectiveness, and safety.

Chlamydia Tests

The U.S. FDA granted marketing authorization to LetsGetChecked for the Simple 2 Test on November 15, 2023. This is the first diagnostic test for Chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. A new WHO report on the Diagnostics Landscape for Sexually Transmitted (July 2023) Infections highlights diagnostics available to support scale-up of screening for STIs, including Chlamydia.

Chlamydia Overview

On April 21, 2023, the U.S. Centers for Disease Control and Prevention (CDC) announced Chlamydia was the most common sexually transmitted disease (STD) in the U.S. in 2021, with 1,644,416 cases, a 3.9% increase compared with 2020, with 58% of all chlamydia cases occurring among people aged 15 to 24 years. If undetected or left untreated, the STD Chlamydia represents a significant cause of pelvic inflammatory disease and infertility in women. In the United Kingdom, chlamydia diagnoses (all ages) increased by 24.3% to 199,233 in 2022.

Chlamydia Vaccine News

April 11, 2024 - The Lancet published an Editorial - Immunological responses in a Chlamydia trachomatis vaccine trial.

May 8, 2023 - Australian scientists have begun vaccinating wild koalas against Chlamydia in an ambitious field trial in New South Wales. A Chlamydia vaccine for koalas has shown promise for replacing antibiotic treatment in mild ocular Chlamydia disease. 

April 12, 2023—Blue Water Vaccines Inc. announced the signing of a Sponsored Research Agreement with the University of Texas Health Science Center at San Antonio to fund a non-human primate study to evaluate the efficacy of BWV-401, a live attenuated, orally delivered Chlamydia vaccine. In this new effort, BWV will fund an NHP study to evaluate the effectiveness of BWV-401 further and provide additional support for development towards human clinical trials.

April 6, 2023—The NEJM journal published the findings from Original Research, which disclosed that the incidence of Chlamydia disease was two-thirds lower following treatment with doxycycline compared to standard care.

March 20, 2023 - Kathryn Frietze, Ph.D., an assistant professor in The University of New Mexico's Department of Molecular Genetics & Microbiology, received a five-year grant from the U.S. NIH for $250,000 per year to support efforts to develop a vaccine for Chlamydia.

February 20, 2023 - Researchers from the University of Washington, Kenya Medical Research Institute, and Hennepin Healthcare Research Institute announced results from a clinical trial demonstrating that doxycycline taken after sex does not prevent bacterial sexually transmitted infections (Chlamydia or gonorrhea) among women. 

May 30, 2022 - The journal Vaccines published: Epitope-Based Vaccines against the Chlamydia trachomatis Major Outer Membrane Protein Variable Domain 4 Elicit Protection in Mice. Immunization with these MS2 VLPs protected from vaginal Chlamydia infection in a murine challenge model. These data suggest that short peptide epitopes targeting the MOMP-VD4 could be appropriate for Ct vaccine design when displayed on an immunogenic bacteriophage VLP vaccine platform.

January 12, 2022 - The journal Vaccines published: Immunogenicity and Protective Capacity of a Virus-like Particle Vaccine against Chlamydia trachomatis Type 3 Secretion System Tip Protein, CT584. These data demonstrate the potential for antibodies against the T3SS to contribute to protection against C. trachomatis and the value of VLPs as a novel platform for C. trachomatis vaccines.

April 28, 2021 - Chlamydia trachomatis vaccines for genital infections: where are we, and how far is there to go? The first Phase, one clinical trial of a C. trachomatis vaccine to protect against genital infections, was completed.

5 min read
Reviewer: 
Robert Carlson, MD
Last Reviewed: 
Wednesday, March 26, 2025 - 13:05
Description: 
Chlamydia is a common STD among women. The U.S. FDA has not approved a vaccine to prevent chlamydia infection.
Condition: 
chlamydia