Clinical trial NCT05844423: Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
Official title: Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pneumococcal Vaccines
Keywords: 24 valent PCV
Pneumonia
Pneumococcal Infection
Lead sponsor: Vaxcyte, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 802
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
timeFrame: 7 days after each vaccination
measure: Percentage of participants with any solicited systemic AE within 7 days after each vaccination
timeFrame: 7 days after each vaccination
measure: Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination
timeFrame: 6 months after last vaccination
Secondary outcomes:
measure: Percentage of subjects with any unsolicited AE within 1 month after each vaccination
timeFrame: 1 month after each vaccination
measure: Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3
timeFrame: First vaccination (Dose 1) through 1 month after third vaccination (Dose 3)
measure: Percentage of subjects with any AE resulting in discontinuation of study 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
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 SAE within 6 months after last vaccination
timeFrame: 6 months after last vaccination
measure: Percentage of subjects achieving an anti-pneumococcal Immunoglobulin G (IgG) antibody concentration ≥0.35 mcg/mL 1 month after Dose 3
timeFrame: 1 month after Dose 3
measure: Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3
timeFrame: 1 month after Dose 3
measure: IgG antibody GMC 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: Opsonophagocytic activity (OPA) Geometric Mean Titer (GMT) 1 month after Dose 3
timeFrame: 1 month after Dose 3
measure: OPA GMT 1 month after Dose 4
timeFrame: 1 month after Dose 4
measure: IgG Geometric Mean Fold Ratio (GMFR) before Dose 4 to 1 month after Dose 4
timeFrame: Pre-Dose 4 to 1 month after Dose 4
measure: OPA GMFR before 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 IgG from pre-Dose 4 to 1 month post Dose 4
timeFrame: Pre-Dose 4 to 1 month after Dose 4
measure: Percentage of subjects achieving at least a 4-fold increase in OPA titers from pre-Dose 4 to 1 month post Dose 4
timeFrame: Pre-Dose 4 to 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: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Tampa
country: United States
facility: Jedidiah Clinical Research
state: Florida
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Haughton
country: United States
facility: ACC Pediatric Research
state: Louisiana
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
city: Dayton
country: United States
facility: Ohio Pediatric Research Assn.
state: Ohio
city: Cranberry Township
country: United States
facility: UPMC Bass Wolfson Cranberry
state: Pennsylvania
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Jefferson Hills
country: United States
facility: UPMC Children's Community Pediatrics South Hills-Jefferson Hills
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Primary Care Center Oakland
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: North Charleston
country: United States
facility: Palmetto Pediatrics, PA
state: South Carolina
city: Simpsonville
country: United States
facility: Tribe Clinical Research at Parkside Pediatrics
state: South Carolina
city: Summerville
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Burleson
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Ventavia
state: Texas
city: Houston
country: United States
facility: Kool Kids Pediatrics
state: Texas
city: Houston
country: United States
facility: Pediatric Associates
state: Texas
city: Richmond
country: United States
facility: Pediatric Center
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research
state: Utah
city: Murray
country: United States
facility: Alliance for Multispecialty Research
state: Utah
city: Provo
country: United States
facility: Alliance for Multispecialty Research
state: Utah
city: Roy
country: United States
facility: Alliance for Multispecialty Research
state: Utah
city: Syracuse
country: United States
facility: Alliance for Multispecialty Research
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
Study officials:
References: