Evaluating Safety and Immune Response of New GSK Strep A Vaccines With Alum or AS37 in Healthy Adults Aged 18 to 25

What this Trial Is About

This research aims to evaluate the safety and immune response of two new formulations of the GSK 4-component Strep A vaccine in healthy young adults aged 18 to 25. The study will assess low, medium, and high doses of the vaccine combined with either an Alum or AS37 adjuvant. It is a phase 1 clinical trial to monitor immediate reactions and immune responses in participants receiving the vaccine for the first time. Participants are randomly assigned to one of seven groups receiving three doses of either low, medium, or high doses of the Strep A vaccine with Alum or AS37 adjuvant, or an Alum placebo. Doses are administered intramuscularly on Day 1, Day 31, and Day 121 in a sequential study design. The trial compares multiple doses and formulations to assess safety and immunogenicity. Throughout the study, participants will be monitored for solicited and unsolicited adverse events for up to 301 days. Laboratory tests, including blood samples, will be collected to assess immune responses at various time points before and after vaccinations. Participants will complete electronic diaries and attend follow-up visits to report any reactions and provide samples for detailed immunological analysis.

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