A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
- Conditions
- Pneumococcal Vaccines
- Interventions
- Biological: 0.5 mL of the low dose VAX-31Biological: 0.5 mL of the mid dose VAX-31Biological: 0.5 mL of the high dose VAX-31Biological: 0.5 mL dose of PCV20
- Registration Number
- NCT06720038
- Lead Sponsor
- Vaxcyte, Inc.
- Brief Summary
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 3 dose levels) compared to PCV20 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
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- Healthy male or female infant ≥42 days to ≤89 days.
- Full-term infant at least 37 weeks gestational age at birth.
- Afebrile for ≥72 hours with an tympanic or rectal temperature <38.0°C (<100.4°F) before receipt of study vaccine.*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours.
- 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 tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
- Subject's parent/legal guardian has an email 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 of hepatitis B vaccine).
- Known hypersensitivity to any vaccine.
- Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
- Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a <14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted.
- History of failure to thrive or prior hospitalization for any chronic condition.
- Subject has a bleeding disorder contraindicating IM vaccination.
- Subject or his/her mother has documented hepatitis B surface antigen-positive test.
- Subject has a known neurologic or cognitive behavioral disorder.
- Subject 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 plans to receive another investigational product 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-31 Low 0.5 mL of the low dose VAX-31 Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. VAX-31 Mid 0.5 mL of the mid dose VAX-31 Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of three dose levels. VAX-31 High 0.5 mL of the high dose VAX-31 Participants will receive 4 doses of VAX-31 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.
- Primary Outcome Measures
Name Time Method Percentage of subjects 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 subjects 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 subjects with any unsolicited AE within 1 month after each vaccination 1 months after each vaccination Percentage of subjects with unsolicited AE
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 MAAE
Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination 6 months after last vaccination Percentage of subjects with SAE
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 NOCI
- Secondary Outcome Measures
Name Time Method Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3 1 month after Dose 3 Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL
Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4 1 month after Dose 4 Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL
Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥1 mcg/mL 1 month after Dose 4 1 month after Dose 4 Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥1 mcg/mL
Serotype-specific 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 31 pneumococcal serotypes in VAX-31
Serotype-specific IgG antibody GMC 1 month after Dose 4 1 month after Dose 4 Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31
Serotype-specific OPA geometric mean titer (GMT) 1 month after Dose 3 1 month after Dose 3 Antibody geometric mean titers as measured by OPA for the 31 pneumococcal serotypes in VAX-31
Serotype-specific OPA GMT 1 month after Dose 4 1 month after Dose 4 Antibody geometric mean titers as measured by OPA for the 31 pneumococcal serotypes in VAX-31
Serotype-specific IgG geometric mean fold rise (GMFR) pre-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 IgG for the 31 pneumococcal serotypes in VAX-31
Serotype-specific OPA GMFR pre-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 31 pneumococcal serotypes in VAX-31
Percentage of subjects achieving at least a 4-fold increase in serotype-specific IgG from pre-Dose 4 to 1 month after Dose 4 Pre-Dose 4 to 1 month after Dose 4 Geometric mean concentration with at least a 4-fold increase in IgG antibodies for the 31 pneumococcal serotypes in VAX-31
Percentage of subjects achieving at least a 4-fold increase in serotype-specific OPA titers from pre-Dose 4 to 1 month after Dose 4 Pre-Dose 4 to 1 month after Dose 4 Geometric mean titer with at least a 4-fold increase in OPA titers for the 31 pneumococcal serotypes in VAX-31
Reverse cumulative distribution curves (RCDC) for serotype-specific IgG concentrations 1 month after dose 3 and 1 month after dose 4 RCDC for serotype-specific IgG concentrations
RCDC for serotype-specific OPA titers 1 month after dose 3 and 1 month after dose 4 RCDC for serotype-specific OPA titers
Related Research Topics
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Trial Locations
- Locations (45)
Orange County Research Institute
🇺🇸Ontario, California, United States
Center for Clinical Trials of San Gabriel
🇺🇸West Covina, California, United States
Children's Hospital of Colorado - Dept. of Infectious Disease
🇺🇸Aurora, Colorado, United States
SEC Clinical Research
🇺🇸Pensacola, Florida, United States
Clinical Research Prime, LLP
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Prime - Rexburg
🇺🇸Rexburg, Idaho, United States
Velocity Clinical Research, Lafayette
🇺🇸Lafayette, Louisiana, United States
Be Well Clinical Studies Nebraska
🇺🇸Lincoln, Nebraska, United States
Prime Global Research Inc
🇺🇸Bronx, New York, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Javara Inc. /Texas Health Care, PLLC
🇺🇸Dallas, Texas, United States
Oak Cliff Research Company
🇺🇸Dallas, Texas, United States
Sunrise Pediatrics
🇺🇸Houston, Texas, United States
University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program
🇺🇸League City, Texas, United States
Radiance Clinical Research- Liberty Hill
🇺🇸Liberty Hill, Texas, United States
Ponce Medical School Foundation Inc. / CAIMED Center
🇵🇷Ponce, Puerto Rico
BRCR Global Puerto Rico
🇵🇷San Juan, Puerto Rico
Caribbean Medical Research Center
🇵🇷San Juan, Puerto Rico
The Children's Clinic of Jonesboro, P.A
🇺🇸Jonesboro, Arkansas, United States
PAS Research
🇺🇸Tampa, Florida, United States
Kentucky Pediatrics/Adult Research
🇺🇸Bardstown, Kentucky, United States
ACC Pediatric Research
🇺🇸Haughton, Louisiana, United States
Complete Children's Health
🇺🇸Lincoln, Nebraska, United States
Ohio Pediatric Research Association
🇺🇸Dayton, Ohio, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry
🇺🇸Cranberry Township, Pennsylvania, United States
Allegheny Health & Wellness Pavilion West
🇺🇸Erie, Pennsylvania, United States
UPMC Children's Community Pediatrics - Norwin
🇺🇸N. Huntingdon, Pennsylvania, United States
UPMC Children's Community Pediatrics South Hills-Jefferson Hills
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)
🇺🇸Pittsburgh, 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
Tribe Clinical Research/Parkside Pediatrics
🇺🇸Simpsonville, South Carolina, United States
Proactive RGV LLC
🇺🇸Brownsville, Texas, United States
Proactive Clinical Research LLC
🇺🇸Edinburg, Texas, United States
Proactive El Paso, LLC
🇺🇸El Paso, Texas, United States
Kool Kids Pediatrics (Dynamed)
🇺🇸Houston, Texas, United States
Mercury Clinical Research - Pediatric Associates
🇺🇸Houston, Texas, United States
Pediatric Center/Neutra Life Sciences
🇺🇸Richmond, Texas, United States
AMR - Layton
🇺🇸Layton, Utah, United States
AMR - Cottonwood
🇺🇸Murray, Utah, United States
AMR - Roy
🇺🇸Roy, Utah, United States
AMR South Jordan
🇺🇸South Jordan, Utah, United States
AMR - Syracuse
🇺🇸Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
🇺🇸Charlottesville, Virginia, United States