Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants

Vaxcyte, Inc.802 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

802

Conditions

Pneumococcal Vaccines

Interventions

0.5 ml dose of 1.1 mcg VAX-24BIOLOGICAL

24 valent pneumococcal conjugate vaccine

0.5 ml dose of PCV20BIOLOGICAL

20 valent pneumococcal conjugate vaccine

0.5 ml dose of 2.2 mcg VAX-24BIOLOGICAL

24 valent pneumococcal conjugate vaccine

Eligibility

Sex: ALLMin age: 42 DaysMax age: 89 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (32)

Outcomes

Primary Outcomes

Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination

Solicited local reactions include erythema, edema, and tenderness at the injection site

Time frame: 7 days after each vaccination

Percentage of participants with any solicited systemic AE within 7 days after each vaccination

Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep

Time frame: 7 days after each vaccination

Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination

Percentage of participants with related SAE

Time frame: 6 months after last vaccination

Secondary Outcomes

Percentage of subjects with any unsolicited AE within 1 month after each vaccination

Percentage of subjects with any unsolicited AE

Time frame: 1 month after each vaccination

Percentage of subjects with any unsolicited AE from Dose 1 through 1 month post-Dose 3

Percentage of subjects with any unsolicited AE between first and 3rd vaccination in the primary series

Time frame: First vaccination (Dose 1) through 1 month after third vaccination (Dose 3)

Percentage of subjects with any AE resulting in discontinuation of study within 6 months after last vaccination

Percentage of subjects with any AE resulting in discontinuation of study

Time frame: 6 months after last vaccination

Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination

Data from ClinicalTrials.gov

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24 valent pneumococcal conjugate vaccine

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

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

...and 22 more locations

Percentage of subjects with any NOCI

Time frame: 6 months after last vaccination

Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination

Percentage of subjects with any MAAE

Time frame: 6 months after last vaccination

Percentage of subjects with any SAE within 6 months after last vaccination

Percentage of subjects with any SAE

Time frame: 6 months after last vaccination

Percentage of subjects achieving an anti-pneumococcal Immunoglobulin G (IgG) antibody concentration ≥0.35 mcg/mL 1 month after Dose 3

Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL

Time frame: 1 month after Dose 3

Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 4

Percentage of subjects achieving an anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL

Time frame: 1 month after Dose 4

IgG antibody Geometric Mean Concentration (GMC) 1 month after Dose 3

Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24

Time frame: 1 month after Dose 3

IgG antibody GMC 1 month after Dose 4

Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24

Time frame: 1 month after Dose 4

Opsonophagocytic activity (OPA) Geometric Mean Titer (GMT) 1 month after Dose 3

Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24

Time frame: 1 month after Dose 3

OPA GMT 1 month after Dose 4

Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24

Time frame: 1 month after Dose 4

IgG Geometric Mean Fold Ratio (GMFR) before 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

Time frame: Pre-Dose 4 to 1 month after Dose 4

OPA GMFR before 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

Time frame: Pre-Dose 4 to 1 month after Dose 4

Percentage of subjects achieving at least a 4-fold increase in IgG from pre-Dose 4 to 1 month post Dose 4

Geometric mean concentration with a at least a 4-fold increase in IgG antibodies for the 24 pneumococcal serotypes in VAX-24

Time frame: Pre-Dose 4 to 1 month after Dose 4

Percentage of subjects achieving at least a 4-fold increase in OPA titers from pre-Dose 4 to 1 month post Dose 4

Geometric mean titer with a at least a 4-fold increase in OPA titers for the 24 pneumococcal serotypes in VAX-24

Time frame: Pre-Dose 4 to 1 month after Dose 4