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

A Phase 1 Randomized, Placebo-controlled, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the GSK 4-component Vaccine Against Group A Streptococcus Pyogenes (Strep A) With Alum or AS37 in Healthy Adults 18 to 25 Years of Age in Australia

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Streptococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Low dose Strep A Alum	Low dose Strep A Alum vaccine will be administered intramuscularly (IM)
BIOLOGICAL	Medium dose Strep A Alum	Medium dose Strep A Alum vaccine will be administered IM
BIOLOGICAL	High dose Strep A Alum	High dose Strep A Alum vaccine will be administered IM
BIOLOGICAL	Low dose Strep A AS37	Low dose Strep A AS37 vaccine will be administered IM
BIOLOGICAL	Medium dose Strep A AS37	Medium dose Strep A AS37 vaccine will be administered IM
BIOLOGICAL	High dose Strep A AS37	High dose Strep A AS37 vaccine will be administered IM
DRUG	Strep A Alum Placebo	Strep A Alum Placebo will be administered IM

Timeline

• Start date: 2025-07-31
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2025-07-25
• Last updated: 2025-08-11

Locations

2 sites across 1 country: Australia