Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
- Conditions
- Pneumococcal Vaccines
- Interventions
- Biological: 0.5 ml dose of 2.2 mcg VAX-24Biological: 0.5 ml dose of 1.1 mcg VAX-24Biological: 0.5 ml dose of PCV20Biological: 0.5 ml dose of 2.2/4.4 mcg VAX-24
- Registration Number
- NCT05844423
- Lead Sponsor
- Vaxcyte, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 802
- Healthy male or female infant ≥42 days to ≤89 days (inclusive).
- Full-term infant at least 37 weeks gestational age at birth.
- 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.*
- Able to attend all scheduled visits and comply with the study procedures.
- Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
- 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.
- Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.
- 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.
- Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
- Known hypersensitivity to any vaccine.
- Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
- Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
- History of failure to thrive.
- Subject has a coagulation disorder contraindicating IM vaccination.
- Subject or his/her mother have documented hepatitis B surface antigen-positive.
- Has a known neurologic or cognitive behavioral disorder.
- Has a known clinically significant congenital malformation or serious chronic disorder.
- Receipt of a blood transfusion or blood products, including immunoglobulins.
- 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.
- Any infant who cannot be adequately followed for safety according to the protocol plan.
- Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VAX-24 Mid 0.5 ml dose of 2.2 mcg VAX-24 Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. VAX-24 Low 0.5 ml dose of 1.1 mcg VAX-24 Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. PCV20 0.5 ml dose of PCV20 Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age. VAX-24 Mixed 0.5 ml dose of 2.2/4.4 mcg VAX-24 Participants will receive 4 doses of VAX-24 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels.
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method Percentage of subjects with any SAE within 6 months after last vaccination 6 months after last vaccination Percentage of subjects with any SAE
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 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
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
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 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
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
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
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 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
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
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 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 medically attended adverse events (MAAE) within 6 months after last vaccination 6 months after last vaccination Percentage of subjects with any MAAE
Related Research Topics
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Trial Locations
- Locations (25)
UPMC Primary Care Center Oakland
🇺🇸Pittsburgh, Pennsylvania, United States
The Children's Clinic of Jonesboro, P.A.
🇺🇸Jonesboro, Arkansas, United States
Madera Family Medical Group
🇺🇸Madera, California, United States
Jedidiah Clinical Research
🇺🇸Tampa, Florida, United States
Kentucky Pediatric/ Adult Research
🇺🇸Bardstown, Kentucky, United States
ACC Pediatric Research
🇺🇸Haughton, Louisiana, United States
Meridian Clinical Research
🇺🇸Hastings, Nebraska, United States
Midwest Children's Health Research Institute
🇺🇸Lincoln, Nebraska, United States
Ohio Pediatric Research Assn.
🇺🇸Dayton, Ohio, United States
UPMC Bass Wolfson Cranberry
🇺🇸Cranberry Township, Pennsylvania, United States
Scroll for more (15 remaining)UPMC Primary Care Center Oakland🇺🇸Pittsburgh, Pennsylvania, United States