Evaluating the Safety and Immune Response of the PfSPZ-LARC2 Vaccine Compared to Placebo in Healthy Adult Women Planning Pregnancy in Mali

What this Trial Is About

Researchers are evaluating the safety, immune response, and protective effects of the PfSPZ-LARC2 Vaccine in healthy adult women of childbearing potential WOCBP aged 18 to 38 years in Mali. This randomized, double-blind, placebo-controlled study involves women who agree to use birth control during vaccination and plan to become pregnant within the next year. The study aims to assess vaccine effects over two years, including during malaria transmission seasons, and closely monitors pregnancy outcomes and infant health. Participants are randomly assigned to one of two groups one receives three doses of the PfSPZ-LARC2 Vaccine via direct venous inoculation at days 1, 6, and 29, while the other group receives placebo injections on the same schedule. All participants receive antimalarial treatment with artemetherlumefantrine about 2 to 4 weeks before the first vaccine dose and about 2 weeks before the third dose. Follow-up includes monitoring for safety, immune responses, and malaria infections during rainy and dry seasons over two years. Pregnant participants and their infants are followed for safety and malaria outcomes through pregnancy and for at least one year after delivery. During the study, participants undergo blood tests, pregnancy monitoring, and assessments for malaria infection and clinical cases. Safety is tracked through recorded adverse events, including injection site reactions and serious events, as well as laboratory tests. Pregnant women and newborns are assessed for obstetric and neonatal health outcomes such as miscarriage, birth weight, and congenital abnormalities. The study collects data on time to first malaria infection, clinical malaria episodes, pregnancy outcomes, and infant infections to understand vaccine impact and safety over the extended follow-up period.

PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali