Phase IIb Study of Blood-Stage Malaria Vaccines RH5.1 and RH5.2 with Matrix-M in Infants Aged 5 to 17 Months in Burkina Faso

What this Trial Is About

Researchers are evaluating the safety, immune response, and effectiveness of two blood-stage malaria vaccine candidates, RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M, in infants aged 5 to 17 months living in Burkina Faso. This Phase IIb randomized controlled trial compares these vaccines against a rabies vaccine control to determine their ability to protect against malaria in a region where malaria is common. Participants will be randomly assigned to receive either the rabies vaccine, RH5.1 with Matrix-M, or RH5.2-VLP with Matrix-M. Vaccinations are administered in three doses on specific schedules some groups receive doses on days 0, 28, and 56, while others receive the third dose later at day 152. Each dose contains a specific amount of the vaccine antigen combined with Matrix-M as an adjuvant. The study follows participants for 12 months after the last vaccination to monitor outcomes. During the study, infants will be closely monitored for malaria cases, vaccine safety, and immune responses through blood tests and clinical evaluations at multiple time points including before vaccination, after each dose, and during follow-up visits up to a year post-vaccination. Researchers will assess protection against clinical and asymptomatic malaria, immune responses, and blood-related complications. Safety checks occur monthly after vaccinations and at 6 and 12 months post-final dose to ensure participant well-being throughout the trial.

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.