Clinical Trials Logo

Clinical Trial Summary

Background: Malaria is a disease that affects many people in Liberia. It is caused by germs (parasites) that are spread by mosquito bites. Researchers want to gather data that may help them understand the best way to use a malaria vaccine in Liberia, which will be important in getting rid of the disease. Objective: To find out how often people of all ages who live in Fleh-la and Marshansue, Liberia, get malaria. Eligibility: Healthy people ages 6 months and older who live in Fleh-la and Marshansue in a household with adults and children. Design: Participants will be screened with a physical exam and questions about their health. Participants will have monthly study visits. They will be asked about any symptoms of malaria and their use of bednets. Their vital signs, such as blood pressure and temperature, will be checked. Blood will be taken from the participant s arm or finger with a needle. If they have a fever, they will get a malaria test. If positive, they will get drugs to treat malaria. Once a month, participants houses will be examined for mosquitoes. The team will remove all mosquitoes they collect. As part of this collection, participants houses will be sprayed with a chemical to kill mosquitoes and other insects. Participants will not be allowed in their house while the team is inside. The spray will not harm the participants. Once a year, at the monthly visit, an additional blood sample will be taken. Some of the participants blood samples will be used for genetic testing. Participation will last for up to 3 years.


Clinical Trial Description

A vaccine that interrupts malaria transmission is critical to eradicate the disease, but improved assays are needed to measure the efficacy of vaccines. Transmission-blocking vaccines (TBVs) work by inducing antibodies that inhibit parasite development in the mosquito interrupting transmission. Efficacy of vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory mosquitoes, but qualified assays that measure transmission in the field are needed to assess transmission-blocking interventions in natura. Clinical trials of TBVs have started elsewhere on the continent in Mali, and we have planned to expand TBV studies here in Liberia soon. This protocol is already being used for a longitudinal cohort to gather information of malaria transmission based on the rates of blood smear positive individuals by month, season and year in Fleh-la and Marshansue, in Salala, Bong County, Liberia. Individuals in the villages were approached first for participation, including permission to contact their household and neighbors of their compound for participation. Households were identified using census data and individuals who consented for participation are being enrolled. Malaria smears are obtained at monthly visits, in conjunction with mosquito collections in/around village residences. Parasite infection rates in locally caught mosquitoes will be assessed longitudinally for differences by season and year. A total of 400 volunteers from Fleh-la and Marshansue will be enrolled. Participants will be followed for at least one year, to collect data that will guide the design of future community-based trials of TBV for which this amendment is being submitted for approval. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04704674
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Active, not recruiting
Phase
Start date September 30, 2021
Completion date February 28, 2025

See also
  Status Clinical Trial Phase
Completed NCT04601714 - Baseline Cohort Malaria Morbidity Study
Withdrawn NCT04020653 - A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria Phase 2
Terminated NCT04368910 - Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria Phase 3
Completed NCT03641339 - Defining Skin Immunity of a Bite of Key Insect Vectors in Humans N/A
Completed NCT02544048 - Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
Completed NCT00527163 - Role of Nitric Oxide in Malaria
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Completed NCT03276962 - Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age Phase 2
Completed NCT04966871 - Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults Phase 1
Completed NCT00289185 - Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants Phase 2
Recruiting NCT03937817 - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Active, not recruiting NCT06153862 - Africa Ready Malaria Screening N/A
Completed NCT04545905 - Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
Recruiting NCT06278181 - Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Withdrawn NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Completed NCT02315690 - Evaluation of Reactive Focal Mass Drug Administration for Malaria Elimination in Swaziland Phase 3
Completed NCT02536222 - Accelerating the Reduction of Malaria Transmission in Kanel, Ranérou and Linguère Districts Phase 4