Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults
Status and phase
Conditions
Treatments
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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.
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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity 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 PCV20 in adults aged 50 to 64 years of age.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Male or female age 18 to 49 years (inclusive) for the Phase 1 group, or 50 to 64 years (inclusive) for the Phase 2 group at the time of enrollment 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.
- Screening laboratory values must be within the central laboratory normal limits prior to study enrollment. Minor abnormalities are considered acceptable if not clinically significant.
- 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.
- Negative pregnancy test (urine and serum) for women of childbearing potential.
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).
- Seropositive to HIV, HCV, or HBsAg.
- History of severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis.
- Female who is breast-feeding or planning to become pregnant during study participation.
- Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or 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 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
Allocation
Interventional model
Masking
835 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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