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

Vaxcyte

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Vaccines

Treatments: Biological: 24-Valent Pneumococcal Conjugate Vaccine; Biological: Pneumococcal 20-valent Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05297578

VAX24-102

Details and patient eligibility

About

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.

Full description

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Enrollment: 207 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 4 patient groups

VAX-24 Low Dose

Experimental group

Description:

Participants will receive a single dose of VAX-24 1.1 mcg administered as an intramuscular injection on Day 1.

Treatment:

Biological: 24-Valent Pneumococcal Conjugate Vaccine

VAX-24 Mid Dose

Experimental group

Description:

Participants will receive a single dose of VAX-24 2.2 mcg administered as an intramuscular injection on Day 1.

Treatment:

Biological: 24-Valent Pneumococcal Conjugate Vaccine

VAX-24 Mixed Dose

Experimental group

Description:

Participants will receive a single dose of VAX-24 2.2 mcg/4.4 mcg administered as an intramuscular injection on Day 1.

Treatment:

Biological: 24-Valent Pneumococcal Conjugate Vaccine

PCV20

Active Comparator group

Description:

Participants will receive a single intramuscular injection of the standard dose of PCV20 on Day 1.

Treatment:

Biological: Pneumococcal 20-valent Conjugate Vaccine