Nanoro Department

Researchers are evaluating the safety and immune response of different doses of a malaria booster vaccine called R21Matrix-M in school children aged 6 to 8 years who previously received four doses of the vaccine in an earlier trial in Burkina Faso. This trial is a double-blind, randomized Phase II study that aims to find the best booster dose to protect children against Plasmodium falciparum malaria. The study is sponsored by the University of Oxford and will run from February 2026 to March 2027. Participants will be randomly assigned to receive one dose of either 5b5g or 10b5g of the R21Matrix-M vaccine, which contains a protein and an adjuvant that helps stimulate the immune system. The lower dose is the standard pediatric dose, while the higher dose is the standard adult dose. Each child will get one booster shot, and the study will compare the safety and immune responses between these two dose groups. During the study, researchers will monitor participants closely for any side effects for up to 28 days after vaccination and check serious adverse events for one year. Blood samples will be taken before vaccination and at one, six, and twelve months afterward to measure immune responses. The total participation lasts about one year after the booster dose, with ongoing safety and health assessments throughout this period.

Researchers are evaluating how well different anti-malarial drugs work and how safe they are for treating uncomplicated Plasmodium falciparum malaria in adults, adolescents, and children. This study focuses on the parasite-killing effects and potential cure rates of these drugs when given alone or combined with others. It also looks at how the drugs are processed by the body to help decide doses for future studies. Participants will receive one of several treatments, including varying doses of the oral drug INE963, combinations of oral KAE609 Cipargamin with INE963 or KLU156, or the standard of care drug Coartem. The study has multiple parts with patients allocated randomly to different treatment groups. Dosing levels and combinations are tested to compare how effectively they clear the malaria parasite. During the study, participants will have their parasite levels monitored up to 7 days and clinical response assessed by day 29. Blood samples will be taken by day 22 to study drug levels and how the body absorbs and clears the medicines. Safety is monitored through reports of side effects until day 43. The total participation lasts through these assessments to understand treatment impact and tolerability.

Researchers are evaluating the safety and effectiveness of antimalarial drugs for treating uncomplicated malaria during the first trimester of pregnancy, a critical period for both mother and baby. The study compares the current standard treatment, artemether-lumefantrine AL, with newer antimalarials like pyronaridine-artesunate PA and dihydroartemisinin-piperaquine DP that have shown promise in earlier studies. The goal is to confirm if these newer drugs work as well as AL and are safe for pregnancy outcomes, while offering benefits such as simpler dosing and longer protection against new infections. The trial uses a Bayesian Adaptive Platform design that allows adding new treatments over time and stopping arms early if safety concerns arise. Pregnant women diagnosed with uncomplicated malaria in their first trimester are randomly assigned to receive AL twice daily for 3 days, or PA or DP once daily for 3 days with weight-based dosing. The study is open-label and conducted in multiple African countries where malaria is common. Participants will be monitored closely with daily visits for 4 days, weekly visits for 6 weeks, followed by monthly visits until delivery. Health and pregnancy outcomes will be tracked, and newborns followed for 6 months after birth. Safety data will be reviewed regularly by an independent monitoring board. The primary measure of success is the clinical and parasitological response at day 42. This research aims to expand safe treatment options for malaria in early pregnancy and improve health outcomes for mothers and babies in malaria-affected regions.

Researchers are conducting a cluster randomized trial to evaluate the impact of seasonal mass vaccination with the R21Matrix M vaccine on malaria transmission and illness across all ages. The study involves 54 villages in The Gambia and Burkina Faso, comparing villages that receive the vaccination with those that do not. The trial aims to measure malaria prevalence, infection incidence, clinical malaria cases, safety, vaccination coverage, and cost-effectiveness during and after the vaccination seasons. In the intervention villages, all eligible residents will receive three monthly doses of the R21 vaccine from May to July 2024, before the malaria transmission season starts, followed by a booster dose in June 2025. Control villages will continue with standard malaria control measures like seasonal chemoprevention and insecticide-treated bed nets. After each vaccination, a subset of participants will be monitored for side effects and asked to report any illness occurring within 28 days. Participants will be involved in surveys to measure malaria prevalence at peak transmission seasons after the initial and booster vaccinations. Blood samples will be collected from selected individuals to assess malaria infection incidence, and passive case detection will track clinical malaria occurrences during the transmission seasons. Safety monitoring includes collecting reports of adverse events following vaccination. The study will last through the 2025 malaria transmission season, with assessments up to six months after vaccinations.