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 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 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 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 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
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
Allegheny Health and Wellness Pavilion
🇺🇸Erie, Pennsylvania, United States
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
🇺🇸Jefferson Hills, Pennsylvania, United States
UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Children's Community Pediatrics-Castle Shannon
🇺🇸Pittsburgh, Pennsylvania, United States
Palmetto Pediatrics, PA
🇺🇸North Charleston, South Carolina, United States
Tribe Clinical Research at Parkside Pediatrics
🇺🇸Simpsonville, South Carolina, United States
Coastal Pediatric Research
🇺🇸Summerville, South Carolina, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Ventavia Research Group
🇺🇸Burleson, Texas, United States
Ventavia
🇺🇸Houston, Texas, United States
Kool Kids Pediatrics
🇺🇸Houston, Texas, United States
Pediatric Associates
🇺🇸Houston, Texas, United States
Pediatric Center
🇺🇸Richmond, Texas, United States
Alliance for Multispecialty Research
🇺🇸Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States