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A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Adults 18 to 25 Years of Age
Led by GlaxoSmithKline · Updated on 2025-08-11
108
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GlaxoSmithKline
Lead Sponsor
H
HHS/BARDA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and immune response of two new formulations of a Group A Streptococcus (Strep A) vaccine in healthy young adults aged 18 to 25 years. This Phase 1 study is the first time these 4-component Strep A vaccines, one with an Alum adjuvant and the other with an AS37 adjuvant, are tested in humans. The goal is to assess any immediate reactions and the body's immune response to different doses of the vaccine. Participants will be randomly assigned to receive one of several study groups, including low, medium, or high doses of either the Strep A Alum vaccine or the Strep A AS37 vaccine, or a placebo. Each participant will receive three intramuscular injections on Day 1, Day 31, and Day 121. The study will monitor reactions and immune responses following each dose. During the study, participants will be closely monitored for side effects such as injection site reactions and systemic symptoms up to seven days after each dose. Laboratory tests will be conducted at multiple time points to check for adverse events and immune responses, including specific antibody levels against Strep A components. Follow-up will continue up to 301 days to assess long-term safety and immune response. Participants will complete electronic diaries and attend scheduled visits throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Strep A Vaccine With Aluminum Hydroxide (Alum) or AS37 in Healthy Young Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants able and willing to comply with study requirements such as completing electronic diaries and attending follow-up visits
- Written or witnessed informed consent obtained before any study procedures
- Healthy as confirmed by medical history, physical exam, and lab tests
- Meets all screening requirements
- Age between 18 and 25 years at informed consent
- Female participants of nonchildbearing potential (defined as premenarche, postmenopause, or sterilized)
- Female participants of childbearing potential must use effective contraception for 1 month before and during the study, have a negative pregnancy test on vaccination days, and agree to continue contraception 1 month after last dose
- Male participants sexually active with female partners must agree their partners use effective contraception from 1 month before to 1 month after last dose
- Male participants must refrain from sperm donation during the same period
- Seronegative for HIV, hepatitis B, and hepatitis C at screening
You will not qualify if you...
- History of rheumatic fever or rheumatic heart disease
- Recent pharyngitis within 4 weeks prior to screening; positive Strep A rapid antigen test at screening
- Progressive, unstable, or uncontrolled medical conditions
- Known or suspected hypersensitivity to any study vaccine component
- Immunosuppressive or immunodeficient conditions
- Allergies to medicinal products or medical equipment used in the study
- Contraindications to intramuscular vaccination or blood draws
- Behavioral, cognitive, or psychiatric conditions that impair study participation
- Acute illness or fever (≥38.0°C) at enrollment
- Clinically significant lab abnormalities
- Echocardiographic findings consistent with carditis
- Recurrent or uncontrolled neurological disorders or seizures
- Personal or family history of autoimmune diseases or acute rheumatic fever
- Significant pulmonary, cardiovascular, hepatic, or renal abnormalities
- Use of long-acting immune-modifying drugs prior to or planned during study
- Prior receipt of experimental Strep A vaccine
- Use of other investigational or unregistered products 30 days before first dose or planned during study
- Receipt of non-protocol vaccines within specified pre-study and study periods
- Use of immunoglobulins, blood products, or bone marrow transplant within 3 months prior or planned during study
- Chronic immunosuppressant use (>14 days) within 3 months prior
- Concurrent participation in other clinical studies involving investigational or invasive devices
- Pregnant or lactating females
- Planning pregnancy or discontinuing contraception during study
- History of chronic alcohol or drug abuse
- Study personnel and their immediate family members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 17 weeks
Participants receive 3 doses of the study vaccine or placebo intramuscularly on Day 1, Day 31, and Day 121.
3 dosing visits on Day 1, Day 31, and Day 121 with additional visits on Day 8, Day 38, and Day 128 for safety assessments
Duration - Approximately 6 months after last dose (up to Day 301)
Participants are monitored for safety and immune response for up to 6 months after the last dose.
Visits at Day 151 and Day 301 for follow-up immunogenicity and safety assessments
Trial Site Locations
Total: 2 locations
1
GSK Investigational Site
Botany, New South Wales, Australia, 2019
Actively Recruiting
2
GSK Investigational Site
Camberwell, Victoria, Australia, 3124
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
7
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