Sigle

Researchers are evaluating the safety and immune response of a multi-stage malaria vaccine combining R21, RH5.1, and/or R78C with Matrix-M adjuvant in a Phase Ib study involving healthy adults aged 18-35 years and children aged 5-17 months in Burkina Faso. This study uses an age de-escalation and dose escalation design to understand how well these vaccine combinations work and how safe they are in a malaria-endemic area. Participants are divided into six groups receiving different combinations of the vaccines: adults receive three doses of R21, RH5.1, and R78C; children receive various combinations including R21 with RH5.1, R21 with R78C, all three vaccines together, R21 alone, or RH5.1 with R78C. All vaccines are given with 50 µg of Matrix-M and administered in a schedule of three doses at 0, 1, and 6 months. Some groups follow a staggered recruitment with safety reviews before age de-escalation and before each vaccination. Participants will be monitored closely for safety, including tracking of side effects at multiple time points up to 365 days after vaccination. Researchers will assess both common and serious adverse events and measure immune responses to the vaccines. The study requires participants to be available for all vaccinations and follow-up visits, with special safety oversight including sentinel participants and Data and Safety Monitoring Board reviews.

Researchers are evaluating the safety, immune response, and effectiveness of two experimental blood-stage malaria vaccines, 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 aims to compare these vaccines against a rabies vaccine control to understand their ability to protect against malaria in a malaria-endemic area. Participants will be randomly assigned to receive either the rabies control vaccine or one of the malaria vaccines in different groups. The vaccines are given in three doses: an initial vaccination, followed by a second dose about four weeks later, and a third dose approximately four weeks after the second or about four months later for some groups. Each dose includes specified amounts of vaccine and adjuvant. After vaccination, participants will be followed for 12 months to observe outcomes. During the study, children will be monitored for malaria cases to assess vaccine protection starting 14 days after the third vaccination and continuing for six months. Safety and reactions to the vaccines will be checked for one month after each dose and at 6 and 12 months after the last vaccination. The trial includes regular evaluations to ensure participant wellbeing and track vaccine effects over time.