Clinical trial NCT06720038: A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants
Official title: A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pneumococcal Vaccines
Keywords: 31 Valent PCV
Pneumonia
Pneumococcal Infection
Lead sponsor: Vaxcyte, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-06
Enrollment: 800
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female infant ≥42 days to ≤89 days.
2. Full-term infant at least 37 weeks gestational age at birth.
3. 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.
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 tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
7. Subject's parent/legal guardian has an email 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 of hepatitis B vaccine).
3. Known hypersensitivity to any vaccine.
4. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
5. 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.
6. History of failure to thrive or prior hospitalization for any chronic condition.
7. Subject has a bleeding disorder contraindicating IM vaccination.
8. Subject or his/her mother has documented hepatitis B surface antigen-positive test.
9. Subject has a known neurologic or cognitive behavioral disorder.
10. Subject 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 plans to receive another investigational product 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.

Primary outcomes:
measure: Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
timeFrame: 7 days after each vaccination
measure: Percentage of subjects with any solicited systemic AE within 7 days after each vaccination
timeFrame: 7 days after each vaccination
measure: Percentage of subjects with any unsolicited AE within 1 month after each vaccination
timeFrame: 1 months after each vaccination
measure: Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
timeFrame: 6 months after last vaccination
measure: Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination
timeFrame: 6 months after last vaccination
measure: Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
timeFrame: 6 months after last vaccination
Secondary outcomes:
measure: Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3
timeFrame: 1 month after Dose 3
measure: Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥1 mcg/mL 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3
timeFrame: 1 month after Dose 3
measure: Serotype-specific IgG antibody GMC 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: Serotype-specific OPA geometric mean titer (GMT) 1 month after Dose 3
timeFrame: 1 month after Dose 3
measure: Serotype-specific OPA GMT 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: Serotype-specific IgG geometric mean fold rise (GMFR) pre-Dose 4 to 1 month after Dose 4
timeFrame: Pre-Dose 4 to 1 month after Dose 4
measure: Serotype-specific OPA GMFR pre-Dose 4 to 1 month after Dose 4
timeFrame: Pre-Dose 4 to 1 month after Dose 4
measure: Percentage of subjects achieving at least a 4-fold increase in serotype-specific IgG from pre-Dose 4 to 1 month after Dose 4
timeFrame: Pre-Dose 4 to 1 month after Dose 4
measure: 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
timeFrame: Pre-Dose 4 to 1 month after Dose 4
measure: Reverse cumulative distribution curves (RCDC) for serotype-specific IgG concentrations
timeFrame: 1 month after dose 3 and 1 month after dose 4
measure: RCDC for serotype-specific OPA titers
timeFrame: 1 month after dose 3 and 1 month after dose 4
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, P.A
state: Arkansas
city: Ontario
country: United States
facility: Orange County Research Institute
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel
state: California
city: Aurora
country: United States
facility: Children's Hospital of Colorado - Dept. of Infectious Disease
state: Colorado
city: Pensacola
country: United States
facility: SEC Clinical Research
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Idaho Falls
country: United States
facility: Clinical Research Prime, LLP
state: Idaho
city: Rexburg
country: United States
facility: Clinical Research Prime - Rexburg
state: Idaho
city: Bardstown
country: United States
facility: Kentucky Pediatrics/Adult Research
state: Kentucky
city: Haughton
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Lafayette
country: United States
facility: Velocity Clinical Research, Lafayette
state: Louisiana
city: Lincoln
country: United States
facility: Complete Children's Health
state: Nebraska
city: Lincoln
country: United States
facility: Complete Children's Health
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies Nebraska
state: Nebraska
city: Lincoln
country: United States
facility: Complete Children's Health
state: Nebraska
city: Lincoln
country: United States
facility: Complete Children's Health
state: Nebraska
city: Bronx
country: United States
facility: Prime Global Research Inc
state: New York
city: Dayton
country: United States
facility: Ohio Pediatric Research Association
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Cranberry Township
country: United States
facility: UPMC Children's Community Pediatrics - Bass Wolfson, Cranberry
state: Pennsylvania
city: Erie
country: United States
facility: Allegheny Health & Wellness Pavilion West
state: Pennsylvania
city: N. Huntingdon
country: United States
facility: UPMC Children's Community Pediatrics - Norwin
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Community Pediatrics South Hills-Jefferson Hills
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh - General Academic Pediatrics (GAP)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Community Pediatrics Bass Wolfson-Squirrel Hill
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Children's Community Pediatrics-Castle Shannon
state: Pennsylvania
city: Simpsonville
country: United States
facility: Tribe Clinical Research/Parkside Pediatrics
state: South Carolina
city: Brownsville
country: United States
facility: Proactive RGV LLC
state: Texas
city: Dallas
country: United States
facility: Javara Inc. /Texas Health Care, PLLC
state: Texas
city: Dallas
country: United States
facility: Oak Cliff Research Company
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research LLC
state: Texas
city: El Paso
country: United States
facility: Proactive El Paso, LLC
state: Texas
city: Houston
country: United States
facility: Kool Kids Pediatrics (Dynamed)
state: Texas
city: Houston
country: United States
facility: Sunrise Pediatrics
state: Texas
city: Houston
country: United States
facility: Mercury Clinical Research - Pediatric Associates
state: Texas
city: League City
country: United States
facility: University of Texas Medical Branch - Sealy Institute for Vaccine Sciences, Clinical Trials Program
state: Texas
city: Liberty Hill
country: United States
facility: Radiance Clinical Research- Liberty Hill
state: Texas
city: Richmond
country: United States
facility: Pediatric Center/Neutra Life Sciences
state: Texas
city: Layton
country: United States
facility: AMR - Layton
state: Utah
city: Murray
country: United States
facility: AMR - Cottonwood
state: Utah
city: Roy
country: United States
facility: AMR - Roy
state: Utah
city: South Jordan
country: United States
facility: AMR South Jordan
state: Utah
city: Syracuse
country: United States
facility: AMR - Syracuse
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc. / CAIMED Center
city: San Juan
country: Puerto Rico
facility: BRCR Global Puerto Rico
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
Study officials:
References: