Phase 2a Study of GVGH iNTS-TCV Vaccine Safety and Immune Response in African Infants Aged 6 Weeks to 6 Months

What this Trial Is About

Researchers are evaluating the safety, reactogenicity, and immune response of the GlaxoSmithKline Biologicals SA GSK Vaccines Institute for Global Health GVGH invasive nontyphoidal Salmonella-typhoid conjugate iNTS-TCV vaccine in infants. The study focuses on administering the first dose either at 6 months of age or at 6 weeks of age. This Phase 2a trial aims to find the appropriate dose and schedule for the vaccine to protect against invasive nontyphoidal Salmonella disease and typhoid fever in infants in Africa. The study involves multiple groups of infants receiving different vaccine schedules and doses. Infants aged 6 months receive three doses of either a low or full dose of iNTS-TCV vaccine on Day 1, Day 85, and Day 337, or combinations of other vaccines including TYPHIBEV, Prevenar 13, and Nimenrix. Infants aged 6 weeks receive similar dosing schedules but with adjusted timing at Day 1, Day 57, and Day 232, including some groups receiving saline doses. The study includes control groups receiving licensed vaccines for comparison. Participants will be closely monitored throughout the study for side effects at the injection site and systemically, with assessments occurring within 7 days after each vaccine dose. Safety monitoring continues for up to 505 days for infants starting at 6 months and 400 days for those starting at 6 weeks. Blood tests will measure immune responses before and after vaccinations, evaluating antibodies against Salmonella and typhoid antigens. The study includes detailed laboratory assessments and tracking of any adverse events or serious complications during the follow-up period.

A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants