drugset / Trial / NCT07085702
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
Phase 1
Recruiting
108 enrolled
GlaxoSmithKline
DHSC/GAMRIF · collabGermany/BMBF · collabHHS/BARDA · collabWellcome Trust · collab
RandomizedSequentialTriple-blindPrevention
Summary
The purpose of this study is to assess the safety of 3 doses of 2 new Strep A vaccine formulations, one with an Alum adjuvant, and the other with AS37 adjuvant. The Strep A vaccine will be tested for the first time in humans, in healthy young adults 18 to 25 years of age. The study will also assess if the vaccines have any immediate reactions and if they induce an immune response. A low, medium, and high dose of each formulation of the vaccine will be assessed in sequence.
Timeline
- Start
- 2025-07-31
- Primary completion
- 2026-11-30
- Completion
- 2026-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Strep A AS37 | Vaccine | — | Intramuscular |
| Subject | Strep A Alum | Vaccine | — | Intramuscular |