VAX-31 for Pneumococcal Infections

Not currently recruiting at 29 trial locations
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

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 safety and effectiveness in preventing pneumococcal infections in adults aged 50 and older. Researchers aim to determine if this vaccine triggers an immune response as strong as or stronger than the existing vaccine, PCV20 (Prevnar 20). Participants must have received a previous pneumococcal vaccine at least a year ago and should be in good health or have stable chronic conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in vaccine development.

Do I need to stop my current medications for the trial?

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 potential vaccine for pneumococcal infections, has a strong safety record from earlier studies. In one study involving over 1,000 adults aged 50 and older, VAX-31 was well tolerated. Its safety profile matched that of PCV20, a vaccine already approved for use. Side effects are usually mild and manageable, similar to those from other vaccines. No serious side effects were reported in these studies, suggesting that VAX-31 is likely safe for most people.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about VAX-31 for pneumococcal infections because it potentially offers broader protection compared to existing vaccines like PPSV23 and PCV20, which are the current standards of care. Unlike these options, VAX-31 aims to target a wider range of pneumococcal strains, which could enhance its effectiveness in preventing infections. Additionally, VAX-31 uses an innovative formulation that might improve the immune response, offering promising advantages over existing vaccines. This potential for broader coverage and enhanced immunity is what makes VAX-31 a standout candidate in the ongoing fight against pneumococcal diseases.

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

Research has shown that VAX-31, a new vaccine for pneumonia, has promising results from earlier studies. It was well tolerated, causing no serious side effects, and its safety profile matched that of another vaccine, PCV20. In this trial, participants will receive either VAX-31 or PCV20. VAX-31 also triggered a strong immune response, meeting or exceeding the effectiveness standards for all 20 types of bacteria it shares with PCV20. This suggests that VAX-31 could offer broad protection against pneumonia infections in adults aged 50 and older.34567

Are You a Good Fit for This Trial?

This trial is for adults aged 50 or older who are in good health or have stable chronic conditions and have received a pneumococcal vaccine at least one year ago (or PCV21 at least six months ago). Participants must be able to use an electronic diary, provide blood samples, and agree to contraception if of childbearing potential.

Inclusion Criteria

I am 50 years old or older.
* 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.
See 6 more

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 VAX-31 or PCV20 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 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VAX-31

Trial Overview

The study compares the safety and immune response of a new 31-valent pneumococcal conjugate vaccine (VAX-31) with an existing vaccine called PCV20. Participants are randomly assigned to receive one of these vaccines.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 3 (VAX-31): Other prior licensed pneumococcal vaccine or combinationExperimental Treatment1 Intervention
Group II: Cohort 2 (VAX-31): Prior PCV20Experimental Treatment1 Intervention
Group III: Cohort 1 (VAX-31): Prior PPSV23Experimental Treatment1 Intervention
Group IV: Cohort 1 (PCV20): Prior PPSV23Active Control1 Intervention
Group V: Cohort 2 (PCV20): Prior PCV20Active Control1 Intervention
Group VI: Cohort 3 (PCV20): Other prior licensed pneumococcal vaccine or combinationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vaxcyte, Inc.

Lead Sponsor

Trials
5
Recruited
3,700+

Citations

Positive VAX-31 Phase 1/2 Adult Data Published in The ...

The study results showed that VAX-31 was observed to be well tolerated and demonstrated a safety profile similar to PCV20 through the full six- ...

Study Details | NCT07284654 | Safety, Tolerability, and ...

The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority ...

Vax 31 Study

This study aims to see how well babies handle VAX-31 and how their immune systems respond to different doses of the vaccine.

Positive VAX-31 Phase 1/2 Adult Data Published in The ...

The study results showed that VAX-31 was observed to be well tolerated and demonstrated a safety profile similar to PCV20 through the full six- ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41864214/

Safety, tolerability, and immunogenicity of a 31-valent ...

The VAX-31 mid-dose and high-dose groups met or exceeded the precedent OPA non-inferiority criterion for all 20 serotypes shared with PCV20, ...

Pneumococcal Vaccine Safety

Learn safety information about the Pneumococcal vaccine.

Safety, tolerability, and immunogenicity of a 31-valent ...

The results of this study suggest that pneumococcal vaccines with high serotype valency can maintain acceptable safety and robust immunogenicity ...