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 a one time SC administration of L9LS in healthy adults in Mali, as well as its protective efficacy against naturally occurring Plasmodium falciparum (Pf) infection over a 6-month malaria season. A secondary objective is to determine if SC administration of L9LS at 900 mg (compared to placebo) mediates protection against naturally occurring Pf infection in healthy Malian adult females stratified by weight during a single malaria season.
EARTH study is conducted as part of the EPIICAL project. It is a prospective cohort study which aims to monitor clinical, virological and immunological features of HIV-positive, early treated children (≤90 days after diagnosis), in order to identify participants with excellent viral and immunological control, and also other without excellent control, in order to stratify potential participants in proof-of-concept trials directed to HIV cure.
For Phase 1 only. Additional information will be provided when Phase 2 is implemented. This is a two-part phase I/II, single-center, observer-blind, randomized, controlled vaccine trial to evaluate the safety, reactogenicity, and immunogenicity of the recombinant ZR202-CoV and ZR202a-CoV vaccines administered at 0 and 28 days as compared to Comirnaty®, and of a booster dose of ZR202a-CoV vaccine in healthy adults. Part 1: A total of 60 eligible subjects will be randomized in a 1:1:1 ratio into one of the three vaccine groups (ZR202-CoV, ZR202a-CoV, or Comirnaty®), receiving 2 doses vaccination at 28 days interval. To assess safety and preliminary immunogenicity profile after primary series vaccination at pre-defined time points during the study. The DSMB will review the safety data and provide a recommendation to the Sponsor on whether the safety profile is acceptable for advancing to Part 2.
Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.
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.
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
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.
Seasonal Malaria Chemoprevention (SMC) for children less than five years old is one the high impact interventions against malaria in sub-Saharan Africa (SSA). Since 2016, the Government of Mali and partners through the National Malaria Control Program has deployed SMC countrywide during high malaria transmission season with a total of four (4) rounds per year. Sulfadoxine-Pyrimethamine (SP) with Amodiaquine (AQ) are the drugs used for SMC. However, SP is also used for Intermittent preventative treatment (IPTp) for pregnant women while AQ has been used for decades for treatment of uncomplicated malaria. The proposed study will examine the effect of SMC with Sulfadoxine+Amodiaquine (SP+AQ) extension to older age, the efficacy of Dihydroartemisin-Piperaquine (DHA-PQ) when used for SMC, social, cultural, economic and health systems factors associated with effective implementation of SMC. The specific aims of this study are to: 1] Assess the effect of SMC (SP+AQ) on malaria incidence and infection prevalence in different age groups across sites; 2] Study the effect of SMC (DHA-PQ) compared to SMC (SP-AQ) among children less than 10 years; 3] Determine the cost-effectiveness for each treatment regimen; ) 4] Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and 5) Establish a district based system to identify severe cases. The expected outcomes of this work, upon completion of our specific aims, include 1) Recommendations to Malian health officials and other partners for improving implementation of SMC and alternative drug to SP+AQ for SMC, and 2) Guidelines for routine monitoring of SMC implementation.