VAX-24 Pneumococcal Vaccine for Infants

No longer recruiting at 29 trial locations

Overseen By Stephen Stripling

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Vaxcyte, Inc.

Must not be taking: Immunosuppressive therapy

Disqualifiers: Pneumococcal disease, Immunodeficiency, Neurologic disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12-15 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new vaccine, VAX-24, to determine its safety and tolerance in infants compared to the existing vaccine, PCV15. Researchers will administer 4 doses of VAX-24 at varying levels or a standard dose of PCV20. The goal is to identify the optimal dose for protection against pneumococcal disease, which can lead to serious infections like pneumonia. Healthy, full-term infants without recent fevers may be suitable candidates for the trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, contributing to important vaccine development.

Do I have to stop taking my current medications for the trial?

The trial does not specify if participants must stop taking their current medications, but it does exclude those using immunosuppressive therapy, except for topical and inhaled/nebulized steroids.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that VAX-24 is generally well-tolerated. Studies have indicated that its safety profile is similar to that of another vaccine, PCV20, with comparable types and amounts of side effects. Most side effects were mild, such as soreness at the injection site, while serious side effects were rare. This suggests that VAX-24 is likely safe for infants at the doses tested. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VAX-24 because unlike current vaccines, it offers a potentially improved immune response against pneumococcal infections in infants. VAX-24 is designed to protect against a broader range of pneumococcal strains compared to existing vaccines like PCV13 and PCV20. Additionally, VAX-24 is being tested at different dose levels to optimize its effectiveness and safety, which could lead to better overall protection for infants. This could be a significant advancement in preventing serious illnesses like pneumonia, meningitis, and bloodstream infections in young children.

What evidence suggests that this trial's treatments could be effective for infants?

Research shows that VAX-24 is a promising vaccine for infants to prevent pneumococcal infections. Earlier studies found it to be as safe as the well-known PCV20 vaccine. In this trial, participants will receive VAX-24 at one of three dose levels or the standard dose of PCV20. VAX-24 aims to provide better protection by targeting more types of bacteria that cause these infections. Initial results indicated that VAX-24 was well-tolerated at all tested doses, suggesting it could help reduce serious infections in infants, similar to existing vaccines. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy infants aged 42 to 89 days, born full-term and without fever. They must be able to attend all visits and their guardians should consent, understand the study, and can record side effects electronically.

Inclusion Criteria

Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.

Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.

I can attend all required visits and follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 4 doses of VAX-24 or PCV20 at 2, 4, 6, and 12-15 months of age

12-15 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the last vaccination

6 months

What Are the Treatments Tested in This Trial?

Interventions

• VAX-24

Trial Overview The trial tests the safety of a new pneumococcal vaccine called VAX-24 at three different dose levels compared to an existing vaccine (PCV15), given at ages 2, 4, 6, and 12-15 months alongside routine vaccines.

How Is the Trial Designed?

Group I: VAX-24 Mixed Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.

Group II: VAX-24 Mid Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.

Group III: VAX-24 Low Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.

Group IV: PCV20 Active Control 1 Intervention

Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age.

Who Is Running the Clinical Trial?

Vaxcyte, Inc.

Lead Sponsor

Trials

5

Recruited

3,700+

Published Research Related to This Trial

In a study involving 523 cases of invasive pneumococcal disease (IPD) in children, both the 13-valent pneumococcal conjugate vaccine (PCV13) and a combination of 7-valent (PCV7) and 10-valent (PCV10) vaccines showed similar effectiveness against all-serotype IPD, with effectiveness rates of 76% and 78%, respectively.

PCV13 demonstrated a high effectiveness of 82% against serotype 19A IPD, while the combined PCV7/PCV10 plus PCV13 showed even higher effectiveness at 87%, indicating that the choice of vaccine can significantly impact protection against specific serotypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Pneumococcal Conjugate Vaccines of Different Valences Against Invasive Pneumococcal Disease Among Children in Taiwan: A Nationwide Study. Su, WJ., Lo, HY., Chang, CH., et al.[2019]

The 13-valent pneumococcal conjugate vaccine is shown to be as safe and effective as the 7-valent vaccine in infants, with both vaccines well tolerated and most reactions being mild or moderate.

The 13-valent vaccine not only protects against the seven common serotypes but also offers expanded protection against six additional serotypes, achieving high immunogenicity with at least 89% of infants reaching protective antibody levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: a meta-analysis. Ruiz-Aragón, J., Márquez Peláez, S., Molina-Linde, JM., et al.[2015]

Citations

1. investors.vaxcyte.com investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-announces-positive-topline-results-vax-24-infant-phase-2

Vaxcyte Announces Positive Topline Results from VAX-24 ... In this study, VAX-24 was well-tolerated and demonstrated a safety profile similar to PCV20 across all doses studied.

2. investors.vaxcyte.com investors.vaxcyte.com/static-files/e069df04-9d63-480d-8376-0eac83477e16

VAX-24 Infant Phase 2 Dose- Finding Study Topline Results 3 % of IPD caused in individuals <5 yrs of age in the U.S. in 2023 based on ABC surveillance data References: https://data.cdc.gov/Public-Health ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05844423

Safety, Tolerability, and Immunogenicity of a 24-Valent ... The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473309923005728

Evaluating the safety, tolerability, and immunogenicity of a ... VAX-24 had a safety profile similar to PCV20 at all doses, with the 2·2 μg dose showing increased serotype coverage with decreased carrier suppression.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10747311/

Pneumococcal Vaccine Breakthrough and Failure in ... The effectiveness of PCVs has been demonstrated through the reductions in pediatric IPD, related hospitalizations, and deaths, as well as AOM, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X24001452

Safety, tolerability and immunogenicity of a novel 24-valent ... In 12–15-month-old toddlers, a single dose of Pn-MAPS24v showed an acceptable safety profile, regardless of dose level; AEs were reported at similar ...