A Phase 2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of AFX3772 Vaccine in Healthy Infants
- Conditions
- Pneumonia, PneumococcalPneumonia, BacterialPneumococcal Infections
- Interventions
- Registration Number
- NCT05412030
- Lead Sponsor
- GlaxoSmithKline
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 472
- Is a full-term infant approximately 2 months of age at time of obtaining the informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 AFX3772 1 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 of the study. Group 2 AFX3772 2 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 \& Part 2 of the study. Group 3 AFX3772 5 mcg AFX3772 administered intramuscularly 4 times within 12 months in Part 1 \& Part 2 of the study. Group 4 Prevnar 13 PCV13 administered intramuscularly 4 times within 12 months in Part 1 of the study. Group 5 Prevnar 20 PCV20 administered intramuscularly 4 times within 12 months in Part 2 of the study.
- Primary Outcome Measures
Name Time Method Percentage of participants with solicited injection site events Day 1 through Day 7 post-vaccination The assessed solicited injection site events are tenderness, redness/erythema and swelling.
Percentage of participants with solicited systemic events Day 1 through Day 7 post-vaccination The assessed solicited systemic events are irritability, fever, decrease of appetite, increased sleep, and decrease in sleep.
Percentage of participants with AEs Day 1 through Day 30 An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention.
Percentage of participants with serious adverse events (SAEs) Day 1 through study completion, an average of 6 months post last vaccine administration An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires in patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity.
Medical or scientific judgment will be exercised by the investigator in deciding whether SAE reporting is appropriate in other situations such as significant medical events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition.
- Secondary Outcome Measures
Name Time Method Percentage of participants with a pneumococcal serotype-specific Immunoglobulin G (IgG) concentration of greater than or equal to (>=) 0.35 μg/mL 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four Immunological responses were assessed in terms of percentage of participants with a pneumococcal serotype-specific IgG concentration \>= 0.35 μg/mL
Geometric mean concentration for serotype-specific IgG 30 days post-dose two, 30 days post-dose three, pre-dose four- and 30-days post-dose four Immunological responses were assessed in terms of IgG GMCs and expressed as titers.
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸South Jordan, Utah, United States