Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults

Completed · Phase 1/Phase 2

Conditions studied: Pneumococcal Vaccines

In brief

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 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older.

Key facts

Study ID

NCT06151288

Run by

Vaxcyte, Inc.

People needed

1015

Starts

2023-11-08

Expected to finish

2024-07-17

Last updated by the study team

2025-07-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female aged 50 to 64 years (inclusive) for Stage 1, or 50 years and older (inclusive) for Stage 2 at the time of randomization into the study.
• Able and willing to complete the informed consent process.
• Available for clinical follow-up through the last study visit at 6 months after the study vaccination.
• In good general health as determined by medical history, vital signs, physical examination, and clinical judgment of the Investigator.
• Willing to have blood samples collected, stored indefinitely, and used for research purposes.
• Able to provide proof of identity to the satisfaction of the study staff completing the enrollment process.
• Women of childbearing potential, defined as premenopausal females capable of becoming pregnant, must have a negative urine pregnancy test immediately prior to randomization and agree to use acceptable contraception
• Able to access and use a smartphone, tablet, computer, or other device connected to Wi-Fi or cellular network for completion of an electronic diary.

You may not qualify if…

• Previous pneumococcal disease (either confirmed or self-reported).
• Previous receipt of a licensed or investigational pneumococcal vaccine.
• Receipt of any investigational study product within 30 days prior to enrollment into the study, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
• Planned or actual administration of any licensed vaccine during the period starting 30 days before enrollment into the study through Month 1.
• Physical examination indicating any clinically significant medical condition.
• Body Temperature >38.0°C (>100.4°F) or acute illness within 3 days prior to study vaccination (subject may be rescheduled).
• Previous or existing diagnosis of HIV, Hepatitis B, or Hepatitis C.
• History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
• Female who is pregnant, breastfeeding, or planning to become pregnant during study participation.
• Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) resulting in clinically significant bruising or bleeding difficulties with IM injections or blood draws.
• Any other chronic or clinically significant medical condition that, in the opinion of the Investigator, would jeopardize the safety or rights of the subject or confound evaluation of the study vaccine.
• 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.
• Received blood or blood product (including Immune Globulin IV) within 90 days prior to enrollment into the study.
• Received systemic corticosteroids (except for inhaled, topical, intra-articular) for
• ≥14 consecutive days and has not completed treatment ≤30 days prior to enrollment into the study.
• Receiving immunosuppressive therapy.
• History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

Where it is running

• AMR Mobile — Mobile, Alabama, United States
• AMR Phoenix — Phoenix, Arizona, United States
• Research Centers of America — Hollywood, Florida, United States
• Health Awareness — Jupiter, Florida, United States
• Optimal Research — Melbourne, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• Velocity Clinical Research, Savannah — Savannah, Georgia, United States
• Healthcare Research Network II, LLC — Flossmoor, Illinois, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States
• DM Clinical Research - Detroit — Detroit, Michigan, United States
• Velocity Clinical Research Omaha — Omaha, Nebraska, United States
• WR-CRCN — Las Vegas, Nevada, United States
• Cenexel AMRI — Toms River, New Jersey, United States
• Rochester Clinical Research — Rochester, New York, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Velocity Clinical Research, Cleveland — Cleveland, Ohio, United States
• DM Clinical Research - Philadelphia — Philadelphia, Pennsylvania, United States
• Velocity Clinical Research — Warwick, Rhode Island, United States
• Coastal Carolina Research — North Charleston, South Carolina, United States
• AMR Knoxville — Knoxville, Tennessee, United States
• Benchmark Research — Fort Worth, Texas, United States
• Benchmark Research — San Angelo, Texas, United States
• CenExel JBR Clinical Research — Salt Lake City, Utah, United States
• Charlottesville Medical Research — Charlottesville, Virginia, United States
• Health Research of Hampton Roads — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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