Bamako

Researchers are studying the persistence of immune response to the NmCV-5 vaccine, a pentavalent meningococcal ACYWX conjugate vaccine, in participants aged 2 to 29 years from Mali and The Gambia. The goal is to understand how long the antibody protection lasts more than five years after a single dose vaccination and whether a booster dose might be needed in this population. This observational long-term follow-up study involves contacting 1800 former participants from an earlier study by phone, followed by an in-person visit for a randomly selected subset of 450 participants. The study focuses on evaluating antibody levels against meningococcal serogroups A, C, Y, W, and X more than five years post-vaccination, measuring geometric mean titers and percentages of participants with specific antibody titers. Participants will be involved in a telephone interview and a clinical visit for blood sampling to assess antibody levels. Researchers will measure immune response persistence using serum bactericidal antibody titers. The study will monitor these immune markers to help determine the duration of vaccine-induced protection. Participation will last beyond five years after the initial vaccination, with safety and compliance monitored throughout.

This registry collects detailed information about children diagnosed with cancer who are treated in pediatric oncology units affiliated with the French African Oncology Group in French-speaking Africa. Its goal is to gather data on patient numbers, cancer stage, treatments received, and outcomes to support better planning and delivery of pediatric oncology care in the region. The registry aims to provide valuable insights for local and national health authorities to improve pediatric cancer programs. Children and adolescents under 18 years old who present at participating pediatric oncology units and have any type of cancer are included in this observational registry. Data collected includes demographic information, socioeconomic status, clinical details, treatment status, vital status, treatment abandonment, and loss to follow-up. The information is entered online using the REDCap system and securely stored by the IT department at Gustave ROUSSY in Paris. Participants information is gathered continuously during their treatment and follow-up at the hospital units. The main measures tracked include the number of children suspected of having cancer within 12-month periods, their vital status, illness status, and treatment status. This ongoing data collection helps monitor outcomes and supports healthcare planning. Participation involves no experimental treatment and is focused on data recording and observation over time.

Malaria caused by Plasmodium falciparum remains a serious global health problem with severe effects, especially during pregnancy and early childhood. This study aims to better understand the immune and parasite-related factors influencing infection and disease in pregnant women and young children in Mali. Researchers are investigating how pregnancy malaria leads to complications like low birth weight and maternal anemia, and how in utero exposure affects childhood malaria risk. The study also explores whether severe malaria parasites in children have unique features. The research is a long-term observational study conducted in Ouelessebougou and Bamako, Mali. It will include up to 2000 pregnant women and their infants, 2000 children aged 0 to 3 years followed until age 5, and 3000 febrile children up to 10 years old from hospitals and health centers. Additionally, 500 pregnant women will participate in a case-control study on pregnancy malaria and preeclampsia. Up to 1000 children previously enrolled at birth will be re-enrolled and followed for up to 10 years into adolescence and early adulthood. Participants will undergo clinical evaluations and periodic blood sampling to monitor infection and immune responses. Researchers will analyze parasitologic and host response factors over time using statistical methods. The primary outcomes focus on maternal, placental, parasite, and host factors associated with resistance to malaria infection and disease in children up to 5 years old. The study includes healthy volunteers aged from newborn to 45 years, with ongoing sample and data analysis.

Researchers are evaluating the effectiveness and real-life impact of a new way to deliver the R21 malaria vaccine combined with seasonal malaria chemoprevention SMC in children living in areas with highly seasonal malaria transmission in Burkina Faso and Mali. This Phase 4, two-arm cluster-randomized trial compares two vaccination approaches in children within defined health center areas, measuring clinical malaria cases, vaccine coverage, acceptability, feasibility, and cost-effectiveness. Children in the control group will receive the R21 vaccine through routine EPI vaccination either year-round for ages 5 to 36 months in Burkina Faso or as an annual campaign before malaria season and SMC delivery in Mali. The intervention group will receive a three-dose primary vaccine series aligned with SMC distribution during an annual campaign, covering children aged 3 to 59 months. These approaches aim to assess different delivery strategies of the R21Matrix-M vaccine alongside SMC. Participants will be monitored through routine malaria surveillance to track clinical malaria incidence. Cross-sectional surveys will check for malaria parasites in the community. Researchers will also assess vaccine coverage, acceptability, feasibility, adverse events, stakeholder perceptions, behavioral factors affecting vaccine uptake, and cost-effectiveness over periods ranging from 4 months up to 36 months after enrollment. The primary outcome is malaria incidence in children aged 5 to 36 months over 12 months from enrollment.

Malaria, particularly caused by Plasmodium falciparum, poses serious health risks to pregnant women and their babies, including low birth weight and maternal anemia. This research focuses on developing and evaluating vaccine candidates aimed at preventing malaria infection during pregnancy. The study emphasizes the importance of antibodies that target placental malaria parasites and compares animal-raised antibodies to those naturally acquired by pregnant women. The study is observational and recruits up to 2492 malaria-infected pregnant women aged 15 to 25 years in Mali. Participants will provide blood samples for in-vitro testing to assess the functional activity of antibodies raised against pregnancy malaria vaccine candidates. These tests will measure how well these antibodies block parasite binding to the placental receptor, with comparisons made to naturally acquired antibodies. During the study, participants will have blood drawn and may undergo physical exams. Women with malaria or anemia will receive treatment. Blood samples will also be stored for future research with consent. The primary outcome measures the antibody activity to block parasite binding over approximately one year. Participant involvement includes monitoring antibody responses and health status throughout the study period ending in 2028.

Researchers are studying allergic diseases such as asthma and atopic dermatitis in people living in Mali to understand factors that may influence these conditions. This observational case-control study compares people with allergic diseases to healthy individuals, examining differences in biological and environmental factors that might be linked to allergic diseases. The goal is to identify clues about the causes and contributing elements of these diseases by analyzing various samples and health information. Participants include people diagnosed with atopic diseases and age- and sex-matched healthy controls. All participants undergo clinical evaluations and provide skin swabs, nasal swabs, induced sputum when possible, blood samples, stool samples, and drinking water samples. They also complete questionnaires about environmental exposures. Pulmonary function tests and skin electrical impedance measurements are performed to assess respiratory and skin function. Environmental samples from the community and participant homes are collected to evaluate pollution exposure. During the study, participants provide biological and environmental samples and complete health questionnaires. Researchers analyze the microbiome diversity in different body sites and measure environmental pollutants and immune markers. The main outcome is the difference in gut microbiome between allergic patients and healthy controls within 28 days after screening. Secondary measures include skin and nasal microbiome analysis, pollutant levels, and immune cell counts. The study involves thorough assessments focused on understanding allergic diseases and their environmental associations.

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.

This research aims to improve treatment for children with Burkitts Lymphoma across at least 14 Sub Saharan countries, some new to this type of study. It focuses on earlier evaluation of children with stage I and II disease and earlier assessment of treatment response to decide if changes are needed. It also intends to intensify treatment for children with stage IV disease. Starting in 2026, the study will assess adding rituximab to current treatments and compare results with earlier implementations in two specific centers. The study involves observing the ability of treatment centers to follow the established GFA LMB2019 protocol for Burkitts Lymphoma. In two units, an amendment adds four rituximab injections during induction treatment, given on day 1 and day 6 of each induction cycle, depending on the risk group and treatment regimen. Other centers will continue using the original GFA LMB2019 treatment protocol without rituximab. Participants will be monitored over five years to evaluate the number of cases diagnosed with local disease and by stage, the treatments given, follow-up after treatment, and relapse rates. The study will also assess how well therapeutic recommendations are applied. This long-term observation helps understand treatment outcomes and the impact of adding rituximab in selected centers.

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.

This research aims to understand inherited neurological disorders, including motor neuron disease, muscular dystrophy, peripheral nervous system diseases, and other related conditions. It studies the genetics, symptoms, disease progression, treatments, and psychological and behavioral effects of these rare and often poorly understood diseases affecting the brain, spinal cord, muscles, and nerves. Both children and adults with diagnosed or undiagnosed inherited neurological disorders may participate. Participants may undergo detailed medical and family history reviews, including drawing a family tree, physical and neurological exams, and various tests such as blood and urine tests, EEGs, psychological evaluations, and speech and rehabilitation assessments. Genetic testing may involve blood samples or skin biopsies. Based on individual symptoms, imaging tests like X-rays, CT or MRI scans, and muscle and nerve testing may also be conducted. This is an observational diagnostic study without assigned treatments. During the study, researchers collect clinical information and biological samples to better characterize these disorders and identify genetic causes. Assessments include neurological exams and various diagnostic tests, with ongoing evaluation until a genetic diagnosis is reached. The study also supports training for fellows and students. Participation may last up to 15 years, contributing to improved diagnosis, treatment, and genetic counseling for inherited neurological conditions.