Nanoro Department

Researchers are evaluating the safety and immune response of a booster dose of the R21/Matrix-M malaria vaccine in school children aged 6 to 8 years who previously received four doses of this vaccine. This phase II randomized, double-blind trial is conducted in Nanoro, Burkina Faso, and aims to compare two different booster doses to find the most appropriate dose for this age group. Participants will be randomly assigned to receive either a 5g R21/50g Matrix-M booster, which is the standard pediatric dose, or a 10g R21/50g Matrix-M booster, the standard adult dose. All participants have already been vaccinated with four doses in the earlier VAC 076 phase IIb trial. After vaccination, participants will be followed for one year to assess the safety and immune response at these two dose levels. During the study, researchers will monitor participants for any reactions to the vaccine within 7 days and track any unsolicited adverse events within 28 days after vaccination. The trial includes regular follow-ups and assessments to evaluate safety and immune effects over the year following the booster dose. The goal is to determine which booster dose is safe and effective for school-age children in malaria-endemic areas.

Researchers are evaluating the effectiveness and safety of different anti-malarial drugs in adults, adolescents, and children with uncomplicated Plasmodium falciparum malaria. This study aims to assess how well these medications kill the malaria parasite and their potential to cure the infection, while also studying how well the drugs are tolerated and how they behave in the body to determine appropriate dosing for future research. The study is a multi-part, multi-center platform trial in Phase 2. Participants may receive one or a combination of oral anti-malarial agents, including INE963, KAE609 (Cipargamin), KLU156 (a combination of KAF156 and lumefantrine), or the standard of care drug Coartem. Treatments are given either alone or in combination, and different parts of the study include specific age and weight groups to evaluate these drugs. The study includes several parts, with participants receiving assigned treatments and being monitored closely. During the study, participants will have their parasite levels checked up to day 7 to measure how quickly the infection clears. On day 29, researchers will evaluate the clinical and parasitological response using polymerase chain reaction (PCR) tests. Participants will undergo various assessments including parasite counts, vital signs, and safety monitoring. The study involves detailed follow-up to assess treatment effectiveness and safety over time, with the total participation duration depending on the study part.

Malaria during early pregnancy is a serious health concern affecting both mothers and their babies. This research aims to find effective and safe treatments for uncomplicated malaria in the first trimester of pregnancy. The study compares the current standard treatment, artemether-lumefantrine (AL), with newer antimalarial drugs that may offer advantages like fewer doses and longer protection against malaria. This multi-center Phase 3 trial uses an innovative adaptive design to quickly evaluate these treatments while ensuring safety for both mother and baby. Participants will be randomly assigned to receive either AL taken twice daily for three days, or one of the newer drugs including dihydroartemisinin-piperaquine or pyronaridine-artesunate, each given once daily for three days with weight-based dosing. The trial design allows new treatments to be added over time and includes early stopping rules if safety concerns arise. The study takes place in several African countries where malaria is common. Women in the first trimester with confirmed malaria will be closely monitored over time. They will have daily visits for four days, weekly visits for six weeks, and monthly visits until delivery. After birth, newborns will be followed for six months. Researchers will assess how well the treatments clear malaria by day 42 and monitor pregnancy outcomes, including any pregnancy loss or birth defects. Safety data will be reviewed regularly by an independent board to protect participants throughout the study.

Researchers are evaluating the impact of seasonal mass vaccination with the R21/Matrix-M vaccine on malaria transmission and illness in all age groups. This Phase 3 cluster-randomized trial includes 54 villages in The Gambia and Burkina Faso, comparing villages that receive the R21 vaccine to those that do not. The study aims to measure malaria prevalence during peak transmission and assess vaccine safety, incidence of malaria infection, clinical malaria cases, vaccination coverage, socio-cultural factors, costs, and cost-effectiveness. It also explores whether blood markers can detect changes in transmission after vaccination. The vaccination involves three monthly doses of R21/Matrix-M administered before the malaria season in May, June, and July 2024, with dosing adjusted by age (5 micrograms for children up to 14 years and 10 micrograms for those 15 and older). A booster dose is given in June 2025. All villages continue to receive standard malaria control measures such as insecticide-treated bed nets and seasonal malaria chemoprevention. Participants are monitored through surveys at peak transmission seasons after vaccination rounds, blood samples to track malaria infection incidence, and passive monitoring of clinical malaria cases throughout the study period, especially during July to December. Safety is tracked via reported adverse events, and detailed data on vaccination coverage and costs are collected. The study spans two years, covering initial vaccination, booster doses, and follow-up assessments to evaluate the vaccine's impact on malaria in the communities.