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

Pneumococcal Vaccines Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05844423
• Other study ID #: VAX24-112
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 29, 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Vaxcyte, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 802
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 89 Days

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Vaccines

Intervention

Biological:
• 0.5 ml dose of 1.1 mcg VAX-24
24 valent pneumococcal conjugate vaccine
• 0.5 ml dose of PCV20
20 valent pneumococcal conjugate vaccine
• 0.5 ml dose of 2.2 mcg VAX-24
24 valent pneumococcal conjugate vaccine
• 0.5 ml dose of 2.2/4.4 mcg VAX-24
24 valent pneumococcal conjugate vaccine

Locations

Country	Name	City	State
United States	Kentucky Pediatric/ Adult Research	Bardstown	Kentucky
United States	Ventavia Research Group	Burleson	Texas
United States	Pediatric Research of Charlottesville, LLC	Charlottesville	Virginia
United States	UPMC Bass Wolfson Cranberry	Cranberry Township	Pennsylvania
United States	Ohio Pediatric Research Assn.	Dayton	Ohio
United States	Allegheny Health and Wellness Pavilion	Erie	Pennsylvania
United States	Meridian Clinical Research	Hastings	Nebraska
United States	ACC Pediatric Research	Haughton	Louisiana
United States	Kool Kids Pediatrics	Houston	Texas
United States	Pediatric Associates	Houston	Texas
United States	Ventavia	Houston	Texas
United States	UPMC Children's Community Pediatrics South Hills-Jefferson Hills	Jefferson Hills	Pennsylvania
United States	The Children's Clinic of Jonesboro, P.A.	Jonesboro	Arkansas
United States	Holston Medical Group	Kingsport	Tennessee
United States	Alliance for Multispecialty Research	Layton	Utah
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	Madera Family Medical Group	Madera	California
United States	Alliance for Multispecialty Research	Murray	Utah
United States	Palmetto Pediatrics, PA	North Charleston	South Carolina
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	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	Alliance for Multispecialty Research	Provo	Utah
United States	Pediatric Center	Richmond	Texas
United States	Alliance for Multispecialty Research	Roy	Utah
United States	Tribe Clinical Research at Parkside Pediatrics	Simpsonville	South Carolina
United States	Coastal Pediatric Research	Summerville	South Carolina
United States	Alliance for Multispecialty Research	Syracuse	Utah
United States	Jedidiah Clinical Research	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vaxcyte, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	7 days after each vaccination
Primary	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	7 days after each vaccination
Primary	Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination	Percentage of participants with related SAE	6 months after last vaccination
Secondary	Percentage of subjects with any unsolicited AE within 1 month after each vaccination	Percentage of subjects with any unsolicited AE	1 month after each vaccination
Secondary	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	First vaccination (Dose 1) through 1 month after third vaccination (Dose 3)
Secondary	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	6 months after last vaccination
Secondary	Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination	Percentage of subjects with any NOCI	6 months after last vaccination
Secondary	Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination	Percentage of subjects with any MAAE	6 months after last vaccination
Secondary	Percentage of subjects with any SAE within 6 months after last vaccination	Percentage of subjects with any SAE	6 months after last vaccination
Secondary	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	1 month after Dose 3
Secondary	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	1 month after Dose 4
Secondary	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	1 month after Dose 3
Secondary	IgG antibody GMC 1 month after Dose 4	Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24	1 month after Dose 4
Secondary	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	1 month after Dose 3
Secondary	OPA GMT 1 month after Dose 4	Antibody geometric mean titers s as measured by OPA for the 24 pneumococcal serotypes in VAX-24	1 month after Dose 4
Secondary	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	Pre-Dose 4 to 1 month after Dose 4
Secondary	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	Pre-Dose 4 to 1 month after Dose 4
Secondary	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	Pre-Dose 4 to 1 month after Dose 4
Secondary	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	Pre-Dose 4 to 1 month after Dose 4