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.
Background: Malaria is a disease spread by mosquitos. Pregnant women are highly susceptible to malaria. This can lead to poor health outcomes for pregnant women and their babies. Researchers want to test a malaria vaccine in women of child bearing potential (WOCBP) and pregnant women. This has not been done before. Objective: To assess the safety and tolerability of PfSPZ vaccine in healthy Malian WOCBP. Eligibility: Healthy women ages 18 38 who live in Ouelessebougou, Mali, and surrounding villages Design: Participants will be screened with: - Physical exam - Medical history - Blood, urine, and heart tests - Multiple-choice test about malaria Participants will get 3 injections by needle into a vein of the study vaccine or a placebo. All 3 will be within 1 month. They will not know whether they receive the vaccine or placebo. Participants will receive treatment to prevent malaria. This will be about 2 weeks before the first and third injections. After the third injection, participants will be followed for about 1 year. They will be tested to see if the vaccine is safe and protects against malaria infection. They will have blood tests. If participants get a rash or injection site reaction, photos of the site may be taken. Any women who become pregnant during the trial will be followed through the end of pregnancy. Babies and their mothers will be followed through the first year of life
This observer-blind, randomized, active controlled trial will be conducted among 2-29 year olds in two sites (Mali and The Gambia). The objectives of the study are to assess and compare the immunogenicity and safety of NmCV-5 with that of Menactra. A total of 1800 eligible participants (who or their parents/guardians have given written informed consent) will be randomised 2:1 (NmCV-5: Menactra) in each of the three age strata 18-29 years, 11-17 years & 2-10 years (400 NmCV-5 recipients & 200 Menactra recipients in each age strata). Each subject will receive a single dose of study vaccine and will be followed up for 6 months post vaccination during which solicited reactions (for seven days), unsolicited AEs (28 days) and SAEs (until the end of study i.e. 168 days after vaccination) will be collected. A blood sample will be collected at baseline (pre-vaccination) and at day 28 post-vaccination for immunogenicity assessment by a Serum Bactericidal Activity assay using rabbit complement (rSBA).
Background: Malaria remains a major global health problem. Malaria is spread by the bite of mosquitos. Africa is the region of the world where most people get malaria. Sanaria PfSPZ Challenge is a malaria vaccine. Researchers want to see if the vaccine combined with partner drugs can help protect against malaria. Objective: To test if injections with 3 monthly doses of Sanaria PfSPZ Challenge, combined with either pyrimethamine (PYR) or chloroquine as a partner drug, is safe, tolerable, and effective. Eligibility: Healthy people ages 18-50 years who live in Bancoumana, Mali, or nearby Design: Participants will be screened with the Malaria Comprehension Exam to check their understanding of the study. They will have a medical history. They will have a physical exam. They will have blood tests, urine tests, and heart tests. Participants will join either the pilot study or the main study. Participants will be assigned to groups. Depending on their group, they will get at least one injection of either a placebo or the vaccine. They may have up to 3 vaccines, 4 weeks apart. The injection will be into a vein with a needle. Participants will also take pyrimethamine or chloroquine by mouth. They will also take standard doses of antimalarial drugs by mouth. Participants will have blood tests throughout the study. Participants may develop a rash or injection site reaction. If this happens, photos of the site may be taken. Participants will be observed for infection for many days after the injections.
Background: Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people. Objective: To test how well an experimental malaria vaccine works to decrease malaria infections. Eligibility: Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas Design: Participants will be screened with: Medical history Physical exam Blood, urine, and heart tests EKG Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting. Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine. Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks. Participants will get another vaccine 1 and 6 months later. Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes. Participants will have visits twice a month for 4 months after their last vaccine.
This 3-arm cluster randomized trial (C-RCT) has the following objectives: Primary Aim To evaluate the effectiveness of an on-site case-based focused low-dose high-frequency training strategy in a primary health care facility labour room, during the provision of care to mothers and newborns, through childbirth and within seven days post-partum for the healthcare providers and the community health workers linked to the health facility in decreasing perinatal mortality. Secondary Aims To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting reduces: - Perinatal morbidity incidence - Post-partum Hemorrhage To determine if introduction of an on-site case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting increases ENC practices: - Early initiation and exclusive breast feeding - Thermal protection (prevention of hypothermia) - Clean cord care - Delayed bathing - Resuscitation-Initiation of breathing To determine if introduction of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting for CHWs decreases: - Delayed Identification of danger signs during pregnancy, labour and perinatal period - Delayed referral of complicated cases during pregnancy, labour and perinatal period To determine the cost effectiveness of a case-based focused low-dose high-frequency training methodology in comparison to MNCH refresher training in a classroom setting
This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td) at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of pregnant subjects, GA will be established by ultrasound, whenever possible, in combination with date of last menstrual period (LMP), when available, and fundal height. Study duration is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and 13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated until she and her infant complete follow-up. The primary objectives of this study are: 1) to assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among infants whose mothers received a single dose of BOOSTRIX or Td while pregnant.
Background: The disease malaria affects many people in Mali and other parts of Africa and the world. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or lead to death if it is not treated promptly. Researchers want to find a safe vaccine that prevents malaria. Objective: To study how safe and tolerable the malaria vaccine called PfSPZ Vaccine is for healthy adults. Eligibility: Healthy adults: - ages 18-35 in Ouelessebougou, Mali - not infected with HIV, hepatitis B, or hepatitis C - for females, not pregnant or breastfeeding and must use reliable birth control during the study Design: Participants will be screened with questions about malaria and will undergo blood, urine, and heart tests. Participants will be randomly assigned to 1 of 4 groups. They will get injections of either the PfSPZ Vaccine or a salt-water placebo. They will not know which one they get. Vaccinations will occur leading into the malaria transmission each year with 3 injections leading into Year 1 (malaria transmission season in 2018) and 1 injection prior to Year 2 (malaria transmission season 2019). One vaccine group and one placebo group will get an injection 3 times over 4 weeks with an additional vaccination ~10 months later. The other two groups (vaccine group and placebo) will get an injection 3 times over 16 weeks with an additional vaccination ~10 months later. All participants will be treated with an antimalarial medication prior to the third injection and prior to fourth injection. They will be followed for approximately 6 months after third and fourth injection. At vaccine visits, female participants will have a pregnancy test before injection. All participants will have an arm cleaned and the vaccine injected in a vein. They will be watched for 30 minutes. At non-vaccine visits, participants will have a physical exam and be asked how they are feeling. They will usually have blood tests.
This demonstration project will assess the acceptability and feasibility of pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) as part of a comprehensive HIV prevention package in community-based clinics in West Africa. An interventional, open label, multidisciplinary and multicentre cohort study will be performed in Burkina Faso, Côte d'Ivoire, Mali, and Togo. All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (daily or on-demand, according the participant's choice), immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.
The primary objective of this study is to estimate the impact of a self-monitoring tool (ChARM), used as a teaching/monitoring device, on the CHWs respiratory rate counting accuracy when assessing children under the age of 5 years with suspected pneumonia symptoms.
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses.This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.