VAX-31 for Pneumococcal Infections

Recruiting at 29 trial locations

Overseen By Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Vaxcyte, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pneumococcal disease, HIV, Hepatitis, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, VAX-31, to evaluate its effectiveness in protecting against pneumococcal infections, which can lead to serious illnesses like pneumonia. The study compares VAX-31 to two existing vaccines to determine if it triggers an immune response as effectively or better. It seeks participants who are generally healthy, have stable chronic conditions, and have not previously received any pneumococcal vaccines. Participants must also be comfortable using electronic devices for study diaries. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking healthcare advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or systemic corticosteroids, you may not be eligible to participate.

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

Research has shown that VAX-31, a new vaccine for pneumococcal infections, is generally safe. Studies have found its safety profile similar to Prevnar 20, a vaccine already in use. Specifically, earlier research indicated that participants who received VAX-31 experienced side effects similar to those of Prevnar 20. This is reassuring, as Prevnar 20 is approved and widely used safely.

For those considering joining a clinical trial, previous studies found that VAX-31's side effects were mild and comparable to other vaccines. No major safety issues were reported over six months, suggesting that VAX-31 is likely to be safe in the ongoing study as well. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike current pneumococcal vaccines like Prevnar 20 and Capvaxive, VAX-31 is generating excitement because it targets a broader range of pneumococcal strains, potentially offering enhanced protection against infections. Most existing vaccines focus on a limited number of strains, but VAX-31 could fill in the gaps by covering additional ones. Researchers are enthusiastic about this treatment because it might reduce the incidence of pneumococcal infections more effectively, especially in younger adults aged 18-49, who are typically less targeted by existing vaccines.

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

Research shows that VAX-31 holds promise in treating pneumococcal infections. In this trial, participants will receive VAX-31, which studies have found boosts the immune system to help the body fight infections. Previous data indicate that VAX-31 is safe for adults aged 50 and older, with a safety level similar to existing treatments like Prevnar. The vaccine targets 31 different strains of the pneumococcus bacteria, offering broader protection than some current options. These findings suggest that VAX-31 could effectively prevent pneumococcal infections. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 50 and older who are healthy enough to participate. It's designed to test a new pneumococcal vaccine (VAX-31) against two existing vaccines (PCV20, PCV21). The goal is to see if the new vaccine works as well or better than the current ones.

Inclusion Criteria

In good general health or with stable underlying chronic condition(s), as determined by medical history, oral temperature, physical examination, and clinical judgment of the Investigator (ongoing chronic conditions must be documented as stable per Investigator)

Willing to have blood samples collected and used for research purposes

Able and willing to complete the informed consent process

Exclusion Criteria

Any medical, psychiatric, or social condition that in the judgment of the Investigator is a contraindication to protocol participation or impairs a subject's ability to give informed consent

I haven't had a live vaccine in the last 30 days or any vaccine in the last 14 days.

History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis to any previous vaccination

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of either VAX-31, PCV20, or PCV21 administered via intramuscular injection at Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity after receiving the vaccine

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VAX-31

Trial Overview

The study tests VAX-31's safety and ability to provoke an immune response compared with PCV20 and PCV21 in those over 50. It also aims to show that immune responses in adults aged 50-64 are similar to those in adults aged 18-49.

How Is the Trial Designed?

Group I: Cohort 2 (VAX-31), participant 18-49 years of age Experimental Treatment 1 Intervention

Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1

Group II: Cohort 1 (VAX-31), participant ≥ 50 years of age Experimental Treatment 1 Intervention

Participants will receive a single dose of VAX-31 administered via intramuscular injection at Day 1

Group III: Cohort 1 (PCV20), participant ≥ 50 years of age Active Control 1 Intervention

Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1

Group IV: Cohort 1 (PCV21), participant ≥ 50 years of age Active Control 1 Intervention

Participants will receive a single dose of PCV21 (Capvaxive) administered via intramuscular injection at Day 1

Group V: Cohort 2 (PCV20), participant 18-49 years of age Active Control 1 Intervention

Participants will receive a single dose of PCV20 (Prevnar 20) administered via intramuscular injection at Day 1

Who Is Running the Clinical Trial?

Vaxcyte, Inc.

Lead Sponsor

Trials

5

Recruited

3,700+

Citations

1.

investors.vaxcyte.com

investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-reports-positive-topline-data-phase-12-study-vax-31-its

Vaxcyte Reports Positive Data for VAX-31 Vaccine in Adults 50+

VAX-31 was observed to be well tolerated and demonstrated a safety profile at all doses studied through the full six-month evaluation period similar to Prevnar ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06151288?term=NCT06151288&rank=1

Safety, Tolerability, and Immunogenicity Study of a 31- ...

The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar ...

3.

contagionlive.com

contagionlive.com/view/vaxcyte-announces-positive-results-for-pneumococcal-vaccine

Vaxcyte Announces Positive Results For Pneumococcal ...

Vaxcyte's VAX-31 vaccine showed strong immune responses and was well tolerated in a Phase 1/2 study of 1,015 adults aged 50 and older. VAX-31 ...

4.

investors.vaxcyte.com

investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-initiates-phase-2-study-evaluating-vax-31-prevention

Vaxcyte Initiates Phase 2 Study: VAX-31 for Infant IPD

This study is evaluating the safety, tolerability and immunogenicity of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent ...

5.

pmc.ncbi.nlm.nih.gov

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

Pneumococcal Vaccine Breakthrough and Failure in ...

Following the introduction of PCV13, one trial demonstrated that serotype 19A accounted for 81.8% of vaccine failures or breakthroughs [31]. In ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12115962/

The New Era of Pneumococcal Vaccination in Adults

Vax-31 is a 31-valent conjugate vaccine that recently finished phase 1/2 trials in adults and demonstrated that the vaccine was well tolerated ...

7.

investors.vaxcyte.com

investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-doses-first-participants-opus-phase-3-noninferiority

Vaxcyte Doses First Participants in the OPUS Phase 3 ...

VAX-31 is Designed to Cover ~95% of Invasive Pneumococcal Disease ... Announce topline safety, tolerability and immunogenicity data for the VAX-31 ...

8.

sec.gov

sec.gov/Archives/edgar/data/1649094/000119312524211572/d813919dex991.htm

EX-99.1

Based on the full six-month safety data, VAX-31 was observed to be well tolerated and demonstrated a safety profile similar to PCV20 at all ...