Kalifabougou

This research investigates the safety and effectiveness of L9LS, a human monoclonal antibody, in protecting against Plasmodium falciparum malaria infection during a 6-month malaria season. The study is a phase 2, randomized, double-blind, placebo-controlled trial primarily involving women of childbearing potential (WOCBP) in Mali. It also includes a smaller, separate open-label male group to examine sex differences in how the antibody is processed in the body. All participants receive artemether-lumefantrine beforehand to clear any existing malaria infection. Participants are randomly assigned to receive a single subcutaneous dose of 1800 mg L9LS or a placebo. The main study group includes 270 women divided by body weight to assess safety and protection against malaria, while 20 men receive the antibody in an open-label arm. Following treatment, participants are monitored through scheduled visits over 24 weeks, with frequent evaluations including physical exams and blood tests. During the study, participants attend visits on Days 1, 3, 7, 14, 21, 28, and then every two weeks up to 24 weeks. Researchers collect blood samples to detect malaria infection and conduct laboratory tests to monitor safety and any adverse events. They also track the severity and occurrence of side effects and lab abnormalities. This detailed follow-up helps assess both the protective effect of L9LS and its safety profile over the malaria season.

Researchers are studying pregnancy outcomes and infant health in Kalifabougou, Mali, with a focus on malaria and pregnancy-related conditions. The study aims to collect background information to support future clinical trials testing monoclonal antibodies to prevent malaria during pregnancy. It involves tracking women of childbearing age and pregnant women to better understand pregnancy rates, complications, and malaria impacts. The study has two parts: a Community Census Cohort and a Health Facility Cohort. In the Community Census Cohort, women of childbearing age are identified and followed for up to three years to detect pregnancies at any stage. When a pregnancy is detected, women may join the Health Facility Cohort, where data is collected during antenatal care visits and throughout pregnancy until 12 months after birth. Infants born to these women will also be followed until they reach 12 months old. Participants will have information collected on early pregnancy events, complications during pregnancy and postpartum, use of malaria prevention methods, malaria infections and clinical disease, birth outcomes, and health of subsequent children. The study tracks outcomes such as number of pregnancies, malaria cases, anemia, maternal deaths, fetal losses, preterm deliveries, and chronic medical conditions over approximately one year from pregnancy through postpartum.