A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants

Pneumococcal Infections Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCV13 in Healthy Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05412030
• Other study ID #: 219651
• Secondary ID: AFX3772-003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 16, 2022
• Est. completion date: July 9, 2026

Study information

• Verified date: February 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2 clinical study to support the use of AFX3772 in healthy infants for the prevention of pneumococcal disease. The purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different dose levels of AFX3772 compared with PCV13. Infants approximately 2 months of age will be enrolled and receive 4 doses of study vaccine over 8 protocol-defined visits spanning a duration of approximately 18 to 21 months. Part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of AFX3772 or PCV13. Enrollment in Cohorts 2 and 3 will proceed following Data Monitoring Committee (DMC) review of cumulative safety and tolerability data from preceding cohorts. Following completion of DMC review of safety and tolerability data for the cohorts enrolled in Part 1, additional infants will be enrolled and randomized equally to receive either PCV13 or AFX3772 at different dose levels approved for evaluation in Part 2.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: July 9, 2026
• Est. primary completion date: July 9, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 90 Days

Eligibility

Inclusion Criteria:

• Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.

Exclusion Criteria:

• Had prior administration of any pneumococcal vaccine.
• Has a known or suspected hypersensitivity to AFX3772, PCV13 or any components of the formulations used.
• Has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. In addition, the participant's biological mother has known HIV infection or known to be hepatitis B surface antigen positive.
• Has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series.
• Has a history of microbiologically proven invasive disease caused by S. pneumoniae.
• Has received immunoglobulins.
• Has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection.
• Has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.
• Has febrile illness at Visit 1.

Related Conditions & MeSH terms

• Pneumococcal Infections
• Pneumonia
• Pneumonia, Bacterial
• Pneumonia, Pneumococcal

Intervention

Biological:
• Prevnar 13
PCV13 administered intramuscularly 4 times within 12 months
• AFX3772
AFX3772 administered intramuscularly 4 times within 12 months

Locations

Country	Name	City	State
United States	GSK Investigational Site	Missoula	Montana
United States	GSK Investigational Site	South Jordan	Utah

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	Affinivax, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To describe the safety and tolerability profiles of 3 different dose levels of AFX3772 compared with PCV13 with respect to the proportion of participants with AEs	Solicited injection site and systemic AEs post-vaccination	Day 1 through Day 7 post-vaccination
Primary	To describe the safety and tolerability profiles of 3 different dose levels of AFX3772 compared with PCV13 with respect to the proportion of participants with AEs	Adverse Events	Day 1 through Day 30
Primary	To describe the safety and tolerability profiles of 3 different dose levels of AFX3772 compared with PCV13 with respect to the proportion of participants with AEs	Serious Adverse Events	Day 1 through study completion, an average of 13 months
Secondary	To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13	Participants with a pneumococcal serotype-specific IgG concentration = 0.35 µg/mL	30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four
Secondary	To evaluate the immunogenicity of 3 different dose levels of AFX3772 compared with PCV13	Serotype-specific IgG GMC	30 days post-dose two, 30 days post-dose three, pre-dose four and 30 days post-dose four