Pneumococcal Vaccines
Conditions
Keywords
24 valent PCV, Pneumonia, Pneumococcal Infection
Brief summary
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
Interventions
BIOLOGICAL0.5 ml dose of 1.1 mcg VAX-24
24 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 ml dose of PCV20
20 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 ml dose of 2.2 mcg VAX-24
24 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 ml dose of 2.2/4.4 mcg VAX-24
24 valent pneumococcal conjugate vaccine
Sponsors
Vaxcyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Triple (Participant, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female infant ≥42 days to ≤89 days (inclusive). 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for ≥72 hours with a rectal temperature \<38.0°C (\<100.4°F) or axillary temperature \<37.8°C (\<100.0°F) before receipt of study vaccine.\* 4. Able to attend all scheduled visits and comply with the study procedures. 5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent. 6. Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination. 7. Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.
Exclusion criteria
1. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. 2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine). 3. Known hypersensitivity to any vaccine. 4. Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency). 5. Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). 6. History of failure to thrive. 7. Subject has a coagulation disorder contraindicating IM vaccination. 8. Subject or his/her mother have documented hepatitis B surface antigen-positive. 9. Has a known neurologic or cognitive behavioral disorder. 10. Has a known clinically significant congenital malformation or serious chronic disorder. 11. Receipt of a blood transfusion or blood products, including immunoglobulins. 12. Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study. 13. Any infant who cannot be adequately followed for safety according to the protocol plan. 14. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination | 7 days after each vaccination | Solicited local reactions include erythema, edema, and tenderness at the injection site |
| Percentage of participants with any solicited systemic AE within 7 days after each vaccination | 7 days after each vaccination | Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep |
| Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination | 6 months after last vaccination | Percentage of participants with related SAE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with any NOCI |
| Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with any MAAE |
| Percentage of subjects with any SAE within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with any SAE |
| Percentage of subjects achieving an anti-pneumococcal Immunoglobulin G (IgG) antibody concentration ≥0.35 mcg/mL 1 month after Dose 3 | 1 month after Dose 3 | Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL |
| Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4 | 1 month after Dose 4 | Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL |
| IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3 | 1 month after Dose 3 | Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24 |
| Percentage of subjects with any unsolicited AE within 1 month after each vaccination | 1 month after each vaccination | Percentage of subjects with any unsolicited AE |
| Opsonophagocytic activity (OPA) Geometric Mean Titer (GMT) 1 month after Dose 3 | 1 month after Dose 3 | Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24 |
| OPA GMT 1 month after Dose 4 | 1 month after Dose 4 | Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24 |
| IgG Geometric Mean Fold Ratio (GMFR) before Dose 4 to 1 month after Dose 4 | Pre-Dose 4 to 1 month after Dose 4 | Antibody geometric mean fold ratio as measured by IgG for the 24 pneumococcal serotypes in VAX-24 |
| OPA GMFR before Dose 4 to 1 month after Dose 4 | Pre-Dose 4 to 1 month after Dose 4 | Antibody geometric mean fold rise as measured by OPA for the 24 pneumococcal serotypes in VAX-24 |
| Percentage of subjects achieving at least a 4-fold increase in IgG from pre-Dose 4 to 1 month post Dose 4 | Pre-Dose 4 to 1 month after Dose 4 | Geometric mean concentration with a at least a 4-fold increase in IgG antibodies for the 24 pneumococcal serotypes in VAX-24 |
| Percentage of subjects achieving at least a 4-fold increase in OPA titers from pre-Dose 4 to 1 month post Dose 4 | Pre-Dose 4 to 1 month after Dose 4 | Geometric mean titer with a at least a 4-fold increase in OPA titers for the 24 pneumococcal serotypes in VAX-24 |
| IgG antibody GMC 1 month after Dose 4 | 1 month after Dose 4 | Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24 |
| Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3 | First vaccination (Dose 1) through 1 month after third vaccination (Dose 3) | Percentage of subjects with any unsolicited AE between first and 3rd vaccination in the primary series |
| Percentage of subjects with any AE resulting in discontinuation of study within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with any AE resulting in discontinuation of study |
Countries
United States
Outcome results
None listed