Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

Completed · Phase 2

Conditions studied: Pneumococcal Vaccines

In brief

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Key facts

Study ID

NCT05297578

Run by

Vaxcyte, Inc.

People needed

207

Starts

2022-06-15

Expected to finish

2023-02-15

Last updated by the study team

2024-10-09

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female age 65 or older.
• 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. Preexisting medical conditions must be stable as defined by no change in treatment at least 6 weeks prior to study participation.
• 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.

You may not qualify if…

• Previous pneumococcal disease (either confirmed or by self-reporting).
• 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 Day 29.
• 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.
• Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular 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 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

• Accel Research Sites-Birmingham Clinical Research Unit — Birmingham, Alabama, United States
• Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States
• CenExel RCA — Hollywood, Florida, United States
• Precision Clinical Research — Sunrise, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Pivotal Research Solutions — Stonecrest, Georgia, United States
• Healthcare Research Network II, LLC — Flossmoor, Illinois, United States
• AMR Newton, formerly Heartland Research Associates — Newton, Kansas, United States
• AMR Wichita West — Wichita, Kansas, United States
• AMR New Orleans — New Orleans, Louisiana, United States
• Healthcare Research Network — Hazelwood, Missouri, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Accellacare of Rocky Mount — Rocky Mount, North Carolina, United States
• Meridian Clinical Research — Cincinnati, Ohio, United States
• Accellacare of Charleston — Mt. Pleasant, South Carolina, United States
• Coastal Carolina Research — North Charleston, South Carolina, United States
• Clinical Trials of Texas, LLC — San Antonio, Texas, United States
• CenExel JBR Clinical Research — Salt Lake City, Utah, United States
• Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States
• Charlottesville Medical Research — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.