Sigle

Researchers are evaluating the safety and immune response of a multi-stage malaria vaccine candidate combining R21 with RH5.1 andor R78C in Matrix-M adjuvant. This Phase Ib open-label study includes healthy adults aged 18 to 35 years and children aged 5 to 17 months in Burkina Faso. The study aims to test different combinations of these vaccines to better understand their effects in populations living in malaria-endemic areas. Participants are divided into six groups. Adults receive three doses of 5 g R21 plus 10 g RH5.1 and 10 g R78C. Children receive different combinations of 5 g or 10 g doses of R21, RH5.1, and R78C vaccines. Each participant receives three intramuscular injections at months 0, 1, and 6, either in the deltoid muscle for adults or the anterolateral thigh for children. Safety monitoring includes staggered recruitment, sentinel participants, and Data Safety Monitoring Board reviews before age de-escalation and subsequent vaccinations. Participants will undergo safety assessments for solicited and unsolicited adverse events at multiple time points up to one year following the first vaccination. Blood samples for immunology testing will be collected at screening, vaccination days, and several follow-ups up to day 365. The study includes ongoing monitoring of serious adverse events and immune responses to evaluate how well the vaccine combinations are tolerated and stimulate the immune system over time.

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.