There are about 191 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 composition of the intestinal bacterial flora effects gut immunologic function and intestinal barrier integrity. HIV infection impairs gut immune and epithelial function resulting in an altered gut bacterial flora and "leakage" of gut bacterial products into the bloodstream. These bacterial products can overstimulate the immune system leading to increased inflammation and HIV disease progression. The investigators will investigate whether oral supplementation of certain beneficial "probiotic" bacteria may attenuate these processes in HIV infected women in Mali, Africa. This is a single arm study to evaluate the effect of 12 weeks of combination oral probiotic supplementation (VSL#3, Sigma-Tau Pharmaceuticals - containing 9 × 1011 bacteria of 8 species: S. thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus plantarum, Lactobacillus acidophilus, Lactobacillus paracasei, and Lactobacillus bulgaricus) on plasma biomarkers of immune cell activation, and inflammation. The study population will be 50 chronically HIV-infected but generally healthy, non-pregnant, Malian women subjects with CD4+ T-cell count ≥ 350 cells/mm3 who are not receiving antiretroviral therapy. Blood plasma/serum and fecal sampling will occur at baseline, 4, and 12 week as well as at 24 weeks. At these time points, probiotic will be dispensed, a medical history will be obtained, and adherence will be assessed. Prior to study entry, subjects will have eligibility and safety labs will be obtained and detailed baseline medical and symptom histories, demographics, weight, and stool frequency information will be recorded. A stress assessment questionnaire will be completed at baseline and week 12 to determine the effect of this intervention on stress levels. The primary study outcome is to assess change (baseline to 12 week) in plasma soluble CD14 (a marker of monocyte response to bacterial endotoxin which has been associated with mortality) with study probiotic. Other outcomes will include assessing change (baseline to 12 week) in plasma interleukin-6, soluble CD163 (another monocyte activation marker), d-dimer (a marker of coagulopathy), intestinal fatty acid binding protein (a marker of gut epithelial cell injury) and fecal calprotectin (a marker of gut inflammation), as well as CD4+ T-cell counts, self reported stool quality (using the Bristol Stool Scale), safety and tolerability of the VSL#3 probiotic, and level of stress.
Ebola virus causes an infection known as Ebola virus disease (EVD). This it is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. This study will assess the safety of a single dose of the bivalent Ebola Zaire candidate vaccine VRC-EBOADC069-00-VP (cAD3-EBO) when administered to healthy Malian adult volunteers, age 18-65 years (mostly health care workers and other front line workers [e.g., individuals who incinerate contaminated materials]), at one of 2 dosage levels, 2.0 x 10(10) vp or 2 x 10(11) vp. It is impossible for someone to get an Ebola infection from this vaccine. Heterologous booster dose allocation - Each participant will be offered the opportunity to be included in the booster step of this study. After obtaining consent and the additional review of pertinent medical history, participants in each group will be randomized to receive the candidate booster vaccine, MVA-EbolaZ or placebo. This will be the first clinical trial in Mali with bivalent cAd3-based Ebola vaccine and the first where the dosage level contains > 10(11) vp. It follows completion of a Phase Ib trial in Malian health care workers that tested three dosage levels of monovalent cAd3-EBO Z vaccine. The data generated in West Africans (Mali) on the tolerability and immunogenicity of the bivalent vaccine will be compared to clinical and immunologic responses documented in in parallel studies in East African subjects (Uganda) and North American subjects (NIH, Bethesda, MD, USA). Objectives: - To see if an Ebola vaccine is safe and to study immune responses to it. - To study the effect of the MVA-EbolaZ booster on the immune response Eligibility: - Healthy adults ages 18-65.
Background: - Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection. Objective: - To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito. Eligibility: - Healthy adults ages 18 50. Design: - There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines. - Vaccinations will be given on two days about 4 weeks apart. - Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination. - In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months. - At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.
Globally, child undernutrition is the underlying cause for 3.1 million deaths of children younger than 5 years. 18.7 million children under five years of age suffer from severe acute malnutrition (SAM) and an additional 33 million children suffer from moderate acute malnutrition, and are at risk of developing SAM In Sub-Saharan Africa, there is often poor integration between programs to treat child acute malnutrition and programs that focus on the prevention of acute and chronic undernutrition - resulting in many missed opportunities for using prevention platforms to screen and refer SAM children, or for using screening and referral platforms to provide prevention services. This project will address two critical gaps related to the integration of preventive and treatment programs: 1) screening and treatment of MAM/SAM have not yet been systematically integrated into routine health-center visits or mainstreamed into community outreach programs; and 2) screening programs do not offer any preventive services for those children found not to be suffering from MAM/SAM at the time of screening; mothers of children identified as non-MAM/SAM case are usually sent home without receiving any health or nutrition inputs and as a result, may fail to come back for screening because they do not see any tangible benefit associated with their participation in the screening. This project will specifically address these gaps by assessing the effect of an integrated approach consisting of higher screening coverage and preventive Behavior Change Communication (BCC) + Small-Quantity Lipid-based Nutrient supplementation (SQ-LNS) on both prevention and treatment of child undernutrition.
Background: - Lassa fever is very similar to other diseases that cause fever, such as malaria and yellow fever. People get Lassa fever from mice. A person can get Lassa fever from mice urine and droppings. When a group of researchers tested the mice in Soromba, Mali, they found that many were infected with Lassa fever. Lassa fever may also be passed through body fluids (like blood or semen) of people infected with Lassa fever. Researchers want to study this disease to help the government better protect the health of people in Sibirila. Objectives: - To find out how many people in Sibirila have ever had Lassa fever. Also, to measure how many people get the disease every year. Eligibility: - People age 6 months and older who are residents of Soromba, Bamba, or Banzana with no plans to relocate within 1 year. Design: - Households will be randomly selected to participate in the study. - Participants will have up to 20 drops of blood collected from the finger or heel. - Participants will be asked about their age. They will be asked if they have ever had a fever and if they have ever seen mice in or around their home. - Researchers will come back in 1 year and take another drop of blood from the participant. Participants will be asked the same questions. - If a participant has a fever at any time during the year, he or she should go to the health center. Researchers will collect a few drops of blood to test for Lassa fever. ...
This study is an evaluation of the immune response to pentavalent rotavirus vaccine (PRV) after an additional fourth dose is given at 9 months of age with local World Health Organization (WHO) Expanded Programme on Immunization (EPI) vaccines in Mali.
Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.
The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ. This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season. Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded. Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period Secondary endpoints: 1. incidence of the primary endpoint during the whole study period 2. attendance at a study health centre with a nonmalaria febrile illness 3. attendance at a study health centre with malaria, 4. the prevalence of moderate anaemia at the end of each malaria transmission season, 5. nutritional status at the end of each malaria transmission season, 6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season, 7. prevalence of resistance markers to SP at the end of the study, Sample size: 19,200 children (9600 in each country) will be enrolled.
Background: - Malaria is a disease that affects many people in Mali and in Africa. It is caused by germs that are spread by mosquito bites. Researchers are creating vaccines that they hope will prevent malaria infection and/or the spread of it. Objective: - To test if the PfSPZ vaccine can stop malaria spread by mosquitoes. Eligibility: - People currently enrolled in the ongoing PfSPZ malaria vaccine trial. Participants must be willing to have uninfected mosquitoes bite them. Design: - Participants will be able to take part in this study at every visit after receiving all scheduled vaccinations. - Participants will be asked whether they are willing to participate in the procedures. Female participants will have a pregnancy test. - Researchers will put about 60 mosquitoes in 2 or 3 cups (20 or 30 in each cup). They will hold each cup to the participant s leg or arm so the mosquitoes can bite. These mosquitoes do not carry germs and will take about 3 drops of blood total. - Participants will get a cream for any swelling or itching. - Participants will be checked the next day for any discomfort. - Participants may take part in this feeding test multiple times, if they are willing. - If participants have malaria parasites in their blood, they may be asked to take part in another study. For this, they will sleep alone in their hut the night after the feeding test. A study team will set up nets to collect mosquitoes that may have bitten the participant overnight.
To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo to elicit a significant antibody response 14 days after vaccination, compared to baseline. To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two dose administration, to elicit antibody response by 14 days after vaccination.