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NCT ID: NCT03510481 Recruiting - Malaria Clinical Trials

Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

Start date: June 20, 2018
Phase: Phase 1
Study type: Interventional

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 Ou(SqrRoot)(Copyright)less(SqrRoot)(Copyright)bougou, 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. One vaccine group and one placebo group will get an injection 3 times over 4 weeks. They will be followed for 7 months for a total of 26 visits. The other two groups (vaccine group and placebo) will get an injection 3 times over 16 weeks. They will be followed for 11 months for a total of 34 visits. All participants will be treated with an antimalarial medication prior to the third 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.

NCT ID: NCT03459157 Recruiting - HIV/AIDS Clinical Trials

Access to PrEP for MSM: Acceptability and Feasibility in Community-based Clinics in West Africa (CohMSM-PrEP)

CohMSM-PrEP
Start date: November 20, 2017
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03457519 Recruiting - Clinical trials for Acute Respiratory Infection

Children's Automated Respiration Monitor (ChARM) for Child Pneumonia Diagnosis by Community Health Workers in Mali

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03352986 Recruiting - Sickle Cell Disease Clinical Trials

Substudy of CADRE: for People With Extreme Phenotype: BIOCADRE

BIOCADRE
Start date: May 15, 2017
Phase: N/A
Study type: Observational

BIOCADRE is a CADRE substudy and aims to characterize more precisely the sickle cell patients with extreme phenotype.

NCT ID: NCT03334747 Recruiting - Malaria Clinical Trials

Safety of KAE609 in Adults With Uncomplicated Plasmodium Falciparum Malaria.

Start date: November 16, 2017
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03304704 Recruiting - Malaria Clinical Trials

Community Dynamics of Malaria Transmission and Mosquito Feeding in Bancoumana, Mali

Start date: June 20, 2018
Phase:
Study type: Observational

Background: Half of the world's population is at risk of malaria. Malaria is a disease that affects many people in Mali and other parts of Africa. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or can lead to death if it is not diagnosed and treated promptly. Researchers want to learn more about the disease so they can develop new approaches to malaria control. Objective: To collect data on how mosquitoes spread malaria and how many people get malaria in the community by comparing different areas, seasons, and years. Eligibility: Residents of a certain area of Mali who are of any age Design: Participants will be screened with a physical exam and medical history. All participants will have at least 1 visit. They will answer questions about their health and malaria. They may have a physical exam. They will have blood collected. Some participants will have 1 visit every month for 3 years. They will repeat the procedures above. These participants will have mosquitoes collected in their home monthly. They may be able to catch some of the mosquitoes alive or may need to use a spray to kill the mosquitoes. Participants in this part of the study can be up to 65 years old. Some participants will also have about 60 mosquitoes directly feed on their arm or leg for 15-20 minutes each month. These participants must be 5-65 years old.

NCT ID: NCT03304691 Recruiting - Malaria Clinical Trials

Molecular Basis of Erythrocyte Invasion by Plasmodium Vivax Into Duffy-Negative Erythrocytes in Children in Bandiagara, Mali

Start date: June 20, 2018
Phase:
Study type: Observational

Background: Malaria is caused by parasites carried by some mosquitos. When the mosquitos bite people, the parasites can infect them. One of these parasites is Plasmodium vivax (P. vivax). Some children have P. vivax in their blood. They did not have malaria symptoms, but some also had a blood problem called anemia. This can make people feel tired or weak. This could have been caused by P. vivax. Researchers want to know how P. vivax infects these children, and if it affects their health. Objective: To collect blood, stool, and urine monthly from children to look for infections with P. vivax, worms, and other parasites. Eligibility: Children between 6 months and 10 years old Design: For screening, the study will be explained to the participant s parents or guardians, who will provide consent. Participants will have a visit once a month for about 3 months, from November to January, and then for about 6 months from June to November 2018. Visits include: Questions about their health Medical history Physical exam Blood draw by pricking the finger tip Urine and stool collection. They may collect these at home and bring them back. If participants have P. vivax in their blood, them may need to come back to the clinic within 3 days. They will have blood taken from their arm using a needle. If participants feel ill during the study, they can go to the clinic for an exam and blood tests. If participants develop malaria while on the study, they will be treated. Participants samples will be stored for future research studies.

NCT ID: NCT03303963 Recruiting - Clinical trials for Tuberculosis, Multidrug-Resistant

DIAgnostics for Multidrug Resistant Tuberculosis in Africa

DIAMA
Start date: May 4, 2017
Phase: N/A
Study type: Observational

Recent advances in molecular diagnostics of tuberculosis, especially the GeneXpert Mycobacterium tuberculosis/Rifampicin test have reduced the time to diagnose Rifampicin Resistant Tuberculosis (RR-TB) but only rifampicin resistance is diagnosed, leading to presumptive diagnosis of resistance to isoniazid and maybe other drugs. Thus in low and middle income countries, most drug sensitivity testing relies on phenotypic drug resistance testing, which takes up to 4 months. In addition, currently, culture on monthly sputum samples is recommended by the World Health Organization for follow-up of Rifampicin Resistant Tuberculosis patients under treatment. Unfortunately, culture is often not locally available and samples need to be transported from field to culture laboratories. The associated transport delays lead to high rates of contamination and false negative culture, particularly in laboratories in low resource settings. Many gaps for the diagnosis and management of RR-TB patients still need to be addressed and the DIAMA project (DIAgnostics for Multidrug resistant tuberculosis in Africa) study aims to address some of them.

NCT ID: NCT03295318 Active, not recruiting - Clinical trials for Meningitis, Meningococcal

Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

Start date: November 15, 2017
Phase: Phase 2
Study type: Interventional

Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet. Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5). The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues. This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®). Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose. The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).

NCT ID: NCT03167242 Recruiting - Clinical trials for Acute Uncomplicated Plasmodium Falciparum Malaria

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

This study aims to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated P. falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.