VAX-31 Vaccine for Pneumococcal Prevention

Recruiting at 49 trial locations

Overseen By Clinical Development

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Vaxcyte, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Pneumococcal disease, Immunodeficiency, Bleeding 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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 13 months

900 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 prevent pneumococcal infections in infants. Researchers aim to assess the vaccine's safety, infant tolerance, and immune response compared to the existing vaccine, PCV20. The study administers four doses of either VAX-31 or PCV20 to infants over several months. Healthy, full-term infants who have been fever-free for at least three days are suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the vaccine's effectiveness in an initial, smaller group of infants.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using immunosuppressive therapy, you may need to stop, as its use is not allowed during the trial.

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

Research has shown that VAX-31 was well tolerated in earlier studies. Its safety profile is similar to that of Prevnar, a well-known vaccine. A six-month evaluation found VAX-31 to be safe at all tested doses, suggesting it might also be safe for infants, as it has been for other groups. The studies found no significant increase in side effects compared to other vaccines like PCV20. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about VAX-31 because it offers a potentially more effective approach to preventing pneumococcal infections, which are commonly addressed by vaccines like PCV13 and PCV20. VAX-31 is unique in that it explores different dosing levels (Low, Mid, High, and High-PFS), which could tailor immune responses more precisely for young children. This flexibility in dosing might enhance protection against a wider range of pneumococcal strains, potentially offering broader and more robust immunity compared to current vaccines.

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

Research has shown that VAX-31, a vaccine designed to protect against various types of pneumococcus bacteria, is promising. Early results suggest that VAX-31 is safe and comparable to other vaccines like Prevnar and PCV20. In this trial, participants will receive VAX-31 at different dose levels—low, mid, high, and high-PFS—to evaluate its safety and immune response. Studies indicate that VAX-31 helps the body build an immune response, which is a positive sign for its effectiveness in preventing infections. So far, VAX-31 has been tested in various doses and appears safe at all levels, suggesting it could potentially help prevent these infections in babies. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for healthy infants who are scheduled to receive routine vaccinations. It's designed to test a new pneumococcal vaccine called VAX-31 at different doses compared with an existing vaccine, PCV20.

Inclusion Criteria

My baby was born full-term, at 37 weeks or later.

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

My infant is between 42 and 89 days old.

Exclusion Criteria

I have had a serious pneumococcal infection confirmed by testing.

Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or plans to receive another investigational product while on study

I have received a blood transfusion or blood products.

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-31 or PCV20 at 2, 4, 6, and 12-15 months of age

13 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• VAX-31

Trial Overview

The study tests the safety and immune response of three different doses of VAX-31 against PCV20 in infants during their regular vaccination schedule at 2, 4, 6, and 12-15 months old. The trial has two stages: initial dose-level testing followed by full enrollment.

How Is the Trial Designed?

Group I: VAX-31 Mid Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Group II: VAX-31 Low Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Group III: VAX-31 High-PFS Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Group IV: VAX-31 High Experimental Treatment 1 Intervention

Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.

Group V: 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.

VAX-31 is already approved in United States for the following indications:

Approved in United States as VAX-31 for:

• Prevention of invasive pneumococcal disease (IPD) in infants and adults

Who Is Running the Clinical Trial?

Vaxcyte, Inc.

Lead Sponsor

Trials

5

Recruited

3,700+

Published Research Related to This Trial

A study analyzing data from Finnish population registers found no significant increase in adverse events after the introduction of the ten-valent Pneumococcal Conjugate Vaccine (PCV10) in children, except for a higher incidence of urticarial rash, which was attributed to changes in healthcare coding rather than the vaccine itself.

The findings suggest that public health concerns regarding adverse events linked to PCV10 are unfounded, highlighting the effectiveness of using real-world data for validating safety signals in vaccination programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Register-Based Ecologic Evaluation of Safety Signals Related to Pneumococcal Conjugate Vaccine in Children. Artama, M., Rinta-Kokko, H., Nohynek, H., et al.[2018]

The heptavalent conjugated pneumococcal vaccine (PCV7) is highly immunogenic and significantly reduces the incidence of invasive pneumococcal disease in children, with reductions of 87% in those under 1 year old after routine vaccination.

While PCV7 is effective in preventing certain types of invasive pneumococcal diseases, its overall impact on acute otitis media is limited, and its cost-effectiveness is questionable after four doses, particularly for children over 4 years old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjugated heptavalent pneumococcal vaccine. Pai, VB., Heyneman, CA., Erramouspe, J.[2017]

The pneumococcal seven valent conjugate vaccine (PCV-7) significantly reduces invasive pneumococcal disease and nasopharyngeal colonization, but its impact on acute otitis media (AOM) rates is minimal, especially in children under 24 months.

Despite the ongoing shortage of PCV-7 leading to fewer doses being administered, the incidence of invasive pneumococcal disease continues to decline, indicating that other factors, such as herd immunity, may also play a role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in treatment strategies for acute otitis media after full implementation of the pneumococcal seven valent conjugate vaccine. Harrison, CJ.[2019]

The 11-valent pneumococcal conjugate vaccine (11-PncTD) was found to be safe and well-tolerated in a study of 50 infants, with local reactions similar to those from the standard DTwP//PRP-T vaccine.

The vaccine elicited strong antibody responses against most pneumococcal serotypes, indicating good immunogenicity, although it was less effective for serotype 14, which had a high pre-vaccination antibody level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of three doses of an eleven-valent diphtheria toxoid and tetanus protein--conjugated pneumococcal vaccine in Filipino infants. Capeding, MZ., Puumalainen, T., Gepanayao, CP., et al.[2018]

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]

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 (13vPnC) was found to be immunogenic in healthy Japanese adults, showing adequate antibody responses for most serotypes, which supports its potential use in children and older adults.

While there was a trend towards more local reactions with the 13vPnC compared to the 23-valent polysaccharide vaccine (23vPn), these reactions were mostly mild or moderate, indicating that the vaccine is generally well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1 trial of 13-valent pneumococcal conjugate vaccine in Japanese adults. Scott, D., Ruckle, J., Dar, M., et al.[2016]

The seven-valent conjugate pneumococcal vaccine is highly effective against invasive pneumococcal disease and is recommended for routine use in infants and high-risk children in the U.S., highlighting its importance in preventing serious infections.

While the vaccine shows effectiveness, there is a concern about serotype replacement, which could diminish its overall effectiveness, and it may also help reduce antimicrobial resistance in pneumococci.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjugate pneumococcal vaccines: an overview. Mulholland, EK.[2020]

The 7-valent conjugate pneumococcal vaccine effectively prevents 75-90% of invasive pneumococcal disease cases in children, depending on the distribution of vaccine serotypes in different countries.

Recent studies in North America indicate that mass vaccination campaigns not only protect vaccinated children but also reduce the spread of antibiotic-resistant vaccine serotypes in the community, suggesting broader public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[7-valent conjugate Pneumococcal vaccine and nasopharyngeal cavity]. Piffer, S.[2015]

The 13-valent pneumococcal conjugate vaccine (PCV13) was found to be as effective as the 7-valent vaccine (PCV7) in generating immune responses to the 7 common pneumococcal serotypes in healthy Japanese infants, while also providing significantly higher responses to 6 additional serotypes.

The combination of PCV13 with the diphtheria, tetanus, and acellular pertussis vaccine (DTaP) was shown to be safe and well tolerated, with comparable immune responses to DTaP antigens across all groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine Given With DTaP Vaccine in Healthy Infants in Japan. Togashi, T., Okada, K., Yamaji, M., et al.[2018]

Pneumococcal conjugate vaccines (PCV7 and PCV9) are highly immunogenic and effective, with PCV7 showing 82-97% efficacy against invasive pneumococcal disease and 90% against pneumococcal pneumonia, based on various randomized controlled trials.

PCVs are generally safe and well-tolerated, even when given alongside other childhood vaccines, and studies suggest that fewer doses (2+1 schedule) can achieve similar protective immunity as the standard 3+1 schedule.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity, efficacy, safety and effectiveness of pneumococcal conjugate vaccines (1998-2006). Oosterhuis-Kafeja, F., Beutels, P., Van Damme, P.[2022]

Children who received 3 or more doses of the 7-valent pneumococcal conjugate vaccine (PCV7) by 12 months of age had a significantly lower risk of acute otitis media (AOM) and lower respiratory tract infections (LRTIs) compared to nonimmunized children, with relative risks of 0.86 and 0.78, respectively.

The study found that PCV7 immunization continued to show reduced risks of AOM and LRTIs between 18 and 36 months of age, but there was no link between PCV7 immunization and asthma at 36 months, indicating its specific protective effects against certain infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decline in early childhood respiratory tract infections in the Norwegian mother and child cohort study after introduction of pneumococcal conjugate vaccination. Magnus, MC., Vestrheim, DF., Nystad, W., et al.[2021]

The 13-Valent pneumococcal conjugate vaccine (PCV13) is as effective as the 7-Valent vaccine (PCV7) in generating immune responses against the common serotypes of pneumococcal disease, while also providing additional protection against 6 extra serotypes.

Both vaccines have similar safety profiles, with PCV13 showing mild reactogenicity, indicating it is a safe option for infants receiving routine vaccinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Yeh, SH., Gurtman, A., Hurley, DC., et al.[2015]

The pneumococcal 7-valent conjugate vaccine has been shown to be highly effective, safe, and immunogenic in infants, who are particularly vulnerable to serious pneumococcal diseases.

Given the rise of drug-resistant strains of S. pneumoniae, this vaccine is crucial for preventing infections like pneumonia and meningitis, with ongoing trials assessing its efficacy against these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumococcal disease in United States children: prevalence and treatment. Clanton, M.[2005]

Citations

1.

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 Evaluating VAX-31 for the ...

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

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06151288

Study Details | NCT06151288 | Safety, Tolerability, and ...

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.

investors.vaxcyte.com

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

Press Release Details

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 ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39260055/

and 31-valent pneumococcal conjugate vaccines

Introduction: Next-generation pneumococcal vaccines currently in clinical trials include 24- and 31-valent pneumococcal conjugate vaccines ( ...

5.

vaccinenation.org

vaccinenation.org/technology/vaxcyte-reports-positive-topline-results-in-study-of-vax-31/

Vaxcyte reports positive topline results in study of VAX-31

Full six-month safety data show that VAX-31 was well tolerated and demonstrated a similar safety profile to PCV20 at all doses studied.

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 ...