Clinical trial NCT05412030: A Phase 2 Study to Evaluate the Safety, Tolerability, and Immune Response of AFX3772 Vaccine in Healthy Infants
Official title: A Phase 2, Randomized, Double-blind, Multi-dose, Dose Finding Study to Evaluate the Safety, Tolerability and Immunogenicity of AFX3772 Compared With PCVs in Healthy Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pneumonia, Bacterial
Pneumococcal Infections
Pneumonia, Pneumococcal
Keywords: Pneumonia, Pneumococcal
Infections
Streptococcal Infections
Pneumonia
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 472
Sex: ALL
Minimum age (years): 42
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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 formulations of AFX3772 compared with Prevnar 13 (PCV13) and Prevnar 20 (PCV). 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 PCV20 or AFX3772 at different dose levels approved for evaluation in Part 2.


Eligibility criteria: 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, PCV20 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.

Primary outcomes:
measure: Percentage of participants with solicited injection site events
timeFrame: Day 1 through Day 7 post-vaccination
measure: Percentage of participants with solicited systemic events
timeFrame: Day 1 through Day 7 post-vaccination
measure: Percentage of participants with AEs
timeFrame: Day 1 through Day 30
measure: Percentage of participants with serious adverse events (SAEs)
timeFrame: Day 1 through study completion, an average of 6 months post last vaccine administration
Secondary outcomes:
measure: Percentage of participants with a pneumococcal serotype-specific Immunoglobulin G (IgG) concentration of greater than or equal to (>=) 0.35 μg/mL
timeFrame: 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four
measure: Geometric mean concentration for serotype-specific IgG
timeFrame: 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four
Other outcomes:
Locations:
city: South Jordan
country: United States
facility: GSK Investigational Site
state: Utah
Study officials:
References: