Phase 1 Evaluation of GVGH Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Adults Aged 18 to 45 in Africa

What this Trial Is About

Researchers are evaluating the GVGH Quadrivalent Pan-Salmonella vaccine in healthy adults aged 18 to 45 living in Africa. This Phase 1 study aims to assess the safety, side effects, and immune response triggered by the Pan-Salmonella vaccine, both with and without an aluminum hydroxide Alum component. The trial will help understand how the vaccine works in this population. Participants will be randomly assigned to one of five groups receiving different treatments low or full doses of the Pan-Salmonella vaccine with Alum, low or full doses without Alum, or a control group receiving placebo and the Typhoid Vi conjugate vaccine at specified time points. Vaccinations are given on Days 1, 61, and 181, with some groups receiving placebo only on Days 1 and 181 and the Typhoid vaccine on Day 61. Throughout the study, participants will be monitored closely for side effects at the injection site and systemic reactions during the week following each vaccination. Blood tests will be done to evaluate immune responses and check for any changes in blood, liver, and kidney functions at multiple time points. Safety assessments continue up to Day 361 to capture any serious adverse events and ensure participant well-being during the study period.

A Study to Evaluate the Safety, Reactogenicity, and Immune Response of the GSK Vaccines Institute for Global Health (GVGH) Quadrivalent Pan-Salmonella Vaccine With and Without Alum in Healthy Young Adults