VAX-24 Pneumococcal Vaccine for Infants

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

802 Participants Needed

Trial Summary

What is the purpose of this trial?

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, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.

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.

What data supports the effectiveness of the treatment VAX-24 Pneumococcal Vaccine for Infants?

Research on a similar vaccine, PCV24, showed it was effective in producing a strong immune response in adult monkeys and provided protection against pneumococcal infection in mice. This suggests that VAX-24, which is also a 24-valent pneumococcal conjugate vaccine, may be effective in infants as well. ^{1 2 3 4 5}

Is the VAX-24 pneumococcal vaccine safe for humans?

In a study with healthy adults, the VAX-24 vaccine was tested for safety and was found to be well-tolerated, similar to other pneumococcal vaccines. In animal studies, it also showed no significant safety concerns. ^{1 2 4 6 7}

How is the VAX-24 vaccine different from other pneumococcal vaccines?

VAX-24 is unique because it covers 24 different strains of the bacteria that cause pneumococcal disease, more than the current vaccines. It uses a special method to produce a protein that helps the body recognize and fight these strains without reducing the vaccine's effectiveness. ^{1 2 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity of PCV24, an expanded pneumococcal conjugate vaccine, in adult monkeys and protection in mice. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Pneumococcal Conjugate Vaccines of Different Valences Against Invasive Pneumococcal Disease Among Children in Taiwan: A Nationwide Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Projected cost-effectiveness of pneumococcal conjugate vaccination of healthy infants and young children. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing health outcomes and costs of general vaccination with pneumococcal conjugate vaccines in Sweden: a Markov model. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of 13-valent pneumococcal conjugate vaccine in infants: a meta-analysis. [2015]

7. Spain pubmed.ncbi.nlm.nih.gov

[Bronchospasm and flushing after vaccination with 23 serotype pneumococcal polysaccharide in chronic patients]. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Four years of universal pneumococcal conjugate infant vaccination in Germany: impact on incidence of invasive pneumococcal disease and serotype distribution in children. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Invasive pneumococcal disease, comorbidities, and polysaccharide vaccine use in children aged 5-15 years in England and Wales. [2015]