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NCT ID: NCT03917654 Recruiting - Malaria Clinical Trials

Safety, Immunogenicity and Efficacy of Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali

Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

A vaccine to interrupt malaria transmission (VIMT), targeting disruption of both human and mosquito transmission, would be a valuable tool for local elimination or eradication of this disease. One strategy to design a VIMT is using components that block transmission of malaria to mosquitoes, such as Pfs230. Pfs230, a surface antigen of intracellular gametocytes, as well as extracellular gametes and zygotes in the mosquito stage of Plasmodium falciparum, is currently the leading candidate in clinical trials for a malaria transmission-blocking vaccine (TBV). Recombinant Pfs230D1M has been conjugated to a recombinant Pseudomonas aeruginosa ExoProtein A (EPA) and adjuvanted with AS01. When formulated in AS01, results from a recent first-in-human trial demonstrated that Pfs230-EPA induces functional transmission-reducing, and in a significant proportion of vaccinees, transmission-blocking serum activity that can be measured for months, the vaccine is well-tolerated and safe in adults, and our recent natural history data clearly indicate that children play a disproportionate role in malaria transmission. The next step in the development of Pfs230D1M-EPA as a TBV is therefore to conduct an age de-escalation trial to ensure that the vaccine is safe to administer to children and then to conduct a community clinical trial to assess efficacy in family groups. This Phase 2 study will first determine safety and tolerability of Pfs230D1M-EPA/AS01 in healthy Malian children of decreasing ages: 9-18 years old, followed by 5-8 years old. A total of 60 subjects will be enrolled in Doneguebougou, Mali, West Africa. Children will be recruited from compounds/family that have agreed to participate in the main phase of the study and will enroll in a staggered manner to receive either Pfs230D1M-EPA/AS01 vaccine or comparator as assigned by their compound block randomization. Prior to receipt of vaccination number 1, all subjects will receive a full treatment course of artemether/lumefantrine (AL). Safety and tolerability will be monitored and reported as local and systemic adverse events (AEs) and serious adverse events (SAEs) and reviewed by DSMB, Sponsor, medical monitors, and study team prior to proceeding with enrollment of the main phase. If there are no safety concerns, in a staggered manner, the main phase will begin enrollment of at least 84 compounds (about 1500 vaccinees + about 400 under 5 years of age for parasite surveillance). Children enrolled during the pilot safety phase will join their main phase compounds/family for vaccination number 3. Prior to receipt of first vaccination, all subjects will receive a full treatment course of AL. All vaccinated subjects will be monitored for safety and tolerability. Immunogenicity outcomes will be antibody responses as measured by enzyme-linked immunosorbent assay (ELISA) against recombinant Pfs230D1M. Functional activity of the induced antibodies will be assessed by standard membrane feeding assays in select samples. Vaccine activity will be measured in children 9-18 years of age who will undergo direct skin feeds (DSF) starting 2 weeks post vaccination number 3 for a total of 8 DSFs. Prior to scheduled last vaccination in members of the compound/family, children 1-4 years of age and vaccinated children 5-8 years of age will receive a full treatment course of AL prior to the expected start of the transmission season and will then be followed every 2 weeks by blood smear (BS) along with all vaccinated children. Children 9-18 years of age will also be assessed for vaccine efficacy, but as a separate analysis from those 1-8 years of age.

NCT ID: NCT03909737 Not yet recruiting - Clinical trials for Stillbirths and Infant Mortality

Oral Azithromycin to Prevent Stillbirths and Infant Mortality in Mali

SANTE
Start date: June 1, 2019
Phase: Phase 4
Study type: Interventional

The double blind randomized controlled trial will assess the efficacy of oral azithromycin administered to pregnant women and/or infants during routine care in preventing stillbirths and mortality through 6-12 months of age in Mali, West Africa, where rates of infant and under five mortality are among the highest in the world.

NCT ID: NCT03783143 Not yet recruiting - Clinical trials for Lassa Virus Infection

Prevalence and Incidence of Lassa Virus Infection in Southern Mali

Start date: April 24, 2019
Phase:
Study type: Observational

Background: The disease Lassa fever mostly affects people in Western Africa. It is very similar to other diseases that cause fever, like malaria and yellow fever. People get Lassa fever from mice infected with Lassa virus. It can also be spread from body fluids of people with the disease. Researchers want to learn more about this virus in Mali so they can develop better tools to diagnose and prevent it. Objective: To find out how many people in certain areas of southern Mali have ever had Lassa fever and count how many people get the disease every year. Eligibility: People ages 6 months to 99 years who live in certain areas of Mali Design: Women who are could become pregnant will have a urine pregnancy test at each visit. Participants will be asked questions about their age, if they have ever had a fever, and if they have ever seen mice in or around their home. This will take about 20 minutes. Participants will give a blood sample using a needle in a vein in the arm. Young children will give it by pricking a finger or heel with a needle. Patients with a fever illness will have a medical history and physical exam. They will give blood and nasal swabs 3 times over 21 days. Participants may be asked to come back 1 time each year for up to 3 more years to take another sample of blood and answer more questions.

NCT ID: NCT03589768 Recruiting - Tetanus Clinical Trials

Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their Infants

Start date: January 24, 2019
Phase: Phase 2
Study type: Interventional

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.

NCT ID: NCT03510481 Active, not 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: April 3, 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: April 24, 2019
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.