Phase 2 Study of One- and Two-Dose Regimens of PfSPZ-LARC2 Malaria Vaccine in Healthy Adults in Burkina Faso

What this Trial Is About

Researchers are evaluating a phase 2 clinical trial of a genetically altered Plasmodium falciparum sporozoite vaccine called PfSPZ-LARC2 in healthy adults living in an area with malaria exposure in Africa. This vaccine uses parasites that stop developing in the liver stage and do not enter the blood, aiming to trigger strong immune responses without causing malaria. The trial compares one-dose and two-dose regimens to see if they can protect against natural malaria infections over time. Participants will be randomly assigned to one of three groups two doses of the vaccine four weeks apart, one dose of placebo followed by one dose of vaccine, or two doses of placebo, all given by direct venous inoculation. Before vaccination, participants will be treated to clear any existing malaria infection. Monitoring for side effects will occur between and after vaccinations, with detailed follow-up for symptoms and laboratory tests. Active and passive surveillance for malaria infections will begin two weeks after immunization and continue up to 40 weeks. During the study, participants will have blood samples taken every two weeks to detect malaria parasites and evaluate immune responses. Malaria symptoms will be closely monitored with immediate testing and treatment if needed. Safety will be tracked through adverse event reporting and laboratory tests. The primary outcome is the vaccines ability to prevent the first malaria infection detected by blood smear during the first 24 weeks after vaccination, with additional follow-up to assess longer-term protection and safety.

Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults