There are about 189 clinical studies being (or have been) conducted in Mali. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of this study is to evaluate the safety and tolerability of onetime subcutaneous (SC) or intravenous (IV) administration of monoclonal antibody (MAb) L9LS in healthy Malian adults and one-time SC administration of L9LS in healthy Malian children, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 7-month malaria season in healthy Malian children 6-10 years of age.
The proposed research is an innovative adaptation of the Centers for Disease Control and Prevention's (CDC) Diabetes Prevention Program "Power to Prevent" program, which will be developed and piloted in the low-income peri-urban neighborhoods of Bamako, Mali. This program is well-suited to delivery by the city's community health workers already supporting families in improving maternal and child health outcomes. First, it will use participatory research methods to engage them and community residents in making adaptations to the community health worker's guidelines and tools for recommended activities so that they are linguistically and culturally appropriate, including guidelines for food consumption using locally available foods. These adaptations will use more graphics and photographs, so they are appropriate for low-literacy participants. Second, another key innovation is the explicit orientation to couples, where only one may have a diagnosed cardiovascular disease. This adaptation will provide tools the women can use in negotiating for changes to the family's meals and her daily routine. Third, investigators will conduct a comparative effectiveness study at 6 community health centers with high rates of Cardiovascular Disease (CVD), recruiting adults recently diagnosed with diabetes or hypertension. Based on the random allocation of their community health center, participants will be assigned to one of three groups of 150 each: Couples, with at least one meeting the eligibility criteria; Individuals, men and women, both eligible; Comparison, men and women with CVD. Trained community health workers and diabetic peer educators will use the adapted Diabetes Prevention Program (DPP) materials with the Couples and Individuals groups over a period of 6 months. At the conclusion of this pilot investigators will assess the levels of adoption of recommended cardiovascular risk reduction behaviors and changes in obesity, hypertension, and diabetes control, comparing differences in outcomes between the three groups. It will enable Mali to incorporate diabetes and hypertension risk reduction into their already deployed networks of community health workers. The Malian DPP adaptation will also be suitable for Francophone West Africa, where customs and lifestyles are similar among the millions of families confronting the burdens of cardiovascular disease.
Admissions criteria which treat children with only low mid-upper arm circumference (MUAC) or children with low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age z-score (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This finding has led to the suggestion that WAZ<-3 could be added as an independent admissions criterion for therapeutic feeding programs currently admitting children with MUAC<125 mm. However, there is little evidence to inform the debate about whether children with MUAC ≥125 mm and WAZ<-3 would benefit from treatment and, if so, what treatment protocol should be used. This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding and whether a simplified protocol is at least as effective as the more complicated weight-based standard protocol for this population. The study will be a prospective, multi-center, individually randomized controlled trial (RCT). Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ<-3 will be randomized to one of three study arms. The primary objective of this study is to assess whether therapeutic feeding with a simplified protocol (1 sachet RUTF/day) results in superior nutritional outcomes compared to no therapeutic feeding AND non-inferior nutritional outcomes compared to the WHZ and weight based dosing regimen currently used in CMAM treatment 2 months after diagnosis among children aged 6-59 months with MUAC ≥125 mm and WAZ<-3 . The primary outcome is the mean WAZ of children. Secondary outcomes include a) proportion of children with WAZ <-3, b) mean MUAC of children, c) proportion of children with MUAC < 125 mm, d) mean WHZ, mean HAZ, e) proportion of children with WHZ<-3 or HAZ<-3, f) change in WAZ, MUAC, WHZ, HAZ from enrolment to endpoint g) mean skinfold thickness measure.
First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg
This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.
Background: Researchers are trying to develop a vaccine that will safely reduce the spread of malaria in the community by preventing mosquitos from carrying malaria from person to person. Objective: To assess in African adults the safety of and immune response to the administration of Pfs230D1-EPA/Matrix-M vaccine as compared to the rabies vaccine control. Eligibility: Healthy adults (18 to 50 years of age) who reside in Sotuba and surrounding villages in Mali Design: Participants will be screened with: - Medical history - Physical exam - Blood, urine, and heart tests - Malaria comprehension exam Participants will be randomly assigned to get either the experimental vaccine or the approved rabies vaccine. They will not know which they are getting. Participants will get 3 doses of the study or comparator vaccine via injection in the upper arm. This occurs at the first visit, 1 month, and 2 months later. Participants will have up to 23 scheduled visits over 14 to 16 months. Each visit includes a physical exam, and blood will be collected at most visits. Participants will be followed up to 1 year after the final vaccination. If participants develop an injection site rash or reaction, photographs may be taken of the site.
InVITE is funded by NIAID and is conducted in multiple international sites (approximately 20 sites across 7 countries). This is a study of adults who receive locally available COVID-19 vaccines through local vaccination programs. Persons will be enrolled within one day (before or after) of receipt of a COVID-19 vaccine. The study will enroll participants who receive COVID-19 vaccination at local clinics and/or study sites.
Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.
The purpose of this study is to compare the gametocytocidal and transmission reducing activity of artemether-lumefantrine (AL) with and without a single dose of 0.25mg/kg primaquine (PQ) and sulfadoxine-pyrimethamine with amodiaquine (SPAQ) with and without single dose of 1.66mg/kg tafenoquine (TQ). Outcome measures will include infectivity to mosquitoes at 2, 5 and 7 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.
In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of PfSPZ Vaccine (or placebo) at 1, 8, and 29-days using direct venous inoculation (DVI). The study is composed of a single cohort with two arms (categorized by placebo control/experimental groups) designed to assess the safety, immunogenicity and protective efficacy of PfSPZ Vaccine. All subjects will receive artemether-lumefantrine (AL) approximately 1- 2 weeks before the first dose of PfSPZ Vaccine or normal saline for clearance of Pf parasitemia. Vaccinated participants and non-immunized controls will be followed for safety and monitored for development of parasitemia through the natural malaria transmission season to estimate vaccine efficacy (VE).