Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03304704
Other study ID # 999917180
Secondary ID 17-I-N180
Status Completed
Phase
First received
Last updated
Start date January 28, 2018
Est. completion date July 12, 2020

Study information

Verified date March 18, 2024
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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 in vaccinees 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 TBV have started in Bancoumana and Doneguebougou, and we expect to expand TBV studies here and in adjacent areas in the future. This protocol will use a longitudinal cohort to gather information on mosquito feeding and infection patterns in Bancoumana, Doneguebougou and surrounding villages in Mali. Individuals actively participating in LMIV vaccine trials will be approached first for participation, including permission to contact their household and neighbors of their compound for participation. Households will be identified using census data and individuals will be consented for participation. Malaria smears will be obtained at monthly visits, in conjunction with mosquito collections in/around village residences and with direct skin feeds (DSFs) using insectary-raised mosquitoes. Parasite transmission to mosquitoes will be assessed longitudinally for differences by season and year, and compared between wild-caught and laboratory-raised mosquitoes. Data will also be obtained on gametocyte and parasite carriage rates by season and year. Genotyping of individual subjects will be performed to pair with the bloodmeals of wild-caught mosquitoes. A total of 3,200 volunteers from Bancoumana, Doneguebougou and surrounding areas will be enrolled into three distinct cohorts. The Genotype Only Cohort (n=1000), which will include the vaccine trial participants, will complete a single visit to obtain a blood sample for genotyping with no additional follow up. The DSF Cohort (n=1200) will enroll subjects aged 5 to 65 years for monthly blood sampling, DSF, and mosquito collection at their household. The Parasite Surveillance Cohort (n=1000) will enroll subjects under the age of 5 years (as young as 6 months) and subjects of any age who are unwilling to participate in DSF; they will have monthly blood sampling and mosquito collection at their household. Enrollment into the Genotype and Parasite Surveillance Cohorts will be linked to full enrollment of the DSF Cohort. Participants in the Parasite Surveillance and DSF cohorts, will be followed for up to 3 years, to collect data that will guide the design of future community-based trials of TBV.


Recruitment information / eligibility

Status Completed
Enrollment 1928
Est. completion date July 12, 2020
Est. primary completion date July 12, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Months to 65 Years
Eligibility - INCLUSION CRITERIA: - GENOTYPE ONLY COHORT - Any age - Known resident of Bancoumana or the surrounding villages - Acceptance and signature of the written informed consent and the assent for children aged 12-17 years - Willingness to allow stored laboratory specimens to be used for future research - PARASITE SURVEILLANCE COHORT - 6 months to 65 years of age - Known resident of Bancoumana or the surrounding villages - Willingness to allow stored laboratory specimens to be used for future research - Acceptance and signature of the written informed consent and the assent for children aged 12-17 years - DSF COHORT - Aged between 5 and 65 years, inclusive - Good general health as determined by review of medical history and/or clinical testing at the time of screening - Known resident of Bancoumana or the surrounding villages - Willingness to allow stored laboratory specimens to be used for future research - Willingness to undergo DSF - Acceptance and signature of the written informed consent and the assent for children aged 12-17 years EXCLUSION CRITERIA: - GENOTYPE ONLY COHORT - Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol - Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol - PARASITE SURVEILLANCE CHORT - Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol - Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol - Currently enrolled participant in protocol 17-I-N006 or another active LMIV/MRTC vaccine clinical trial - DSF COHORT - Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol - Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol - Currently enrolled participant in protocol 17-I-N006 or another LMIV/MRTC vaccine clinical trial - History of severe reaction to mosquito bites

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Mali Bancoumana Malaria Vaccine Center Bamako
Mali Univ of Sciences, Techniques and Technology Bamako
Mali Doneguebougou Facility Doneguebougou

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Mali, 

References & Publications (3)

Diallo M, Toure AM, Traore SF, Niare O, Kassambara L, Konare A, Coulibaly M, Bagayogo M, Beier JC, Sakai RK, Toure YT, Doumbo OK. Evaluation and optimization of membrane feeding compared to direct feeding as an assay for infectivity. Malar J. 2008 Dec 2;7:248. doi: 10.1186/1475-2875-7-248. — View Citation

Drakeley C, Sutherland C, Bousema JT, Sauerwein RW, Targett GA. The epidemiology of Plasmodium falciparum gametocytes: weapons of mass dispersion. Trends Parasitol. 2006 Sep;22(9):424-30. doi: 10.1016/j.pt.2006.07.001. Epub 2006 Jul 17. — View Citation

Toure YT, Doumbo O, Toure A, Bagayoko M, Diallo M, Dolo A, Vernick KD, Keister DB, Muratova O, Kaslow DC. Gametocyte infectivity by direct mosquito feeds in an area of seasonal malaria transmission: implications for Bancoumana, Mali as a transmission-blocking vaccine site. Am J Trop Med Hyg. 1998 Sep;59(3):481-6. doi: 10.4269/ajtmh.1998.59.481. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of estimated rates of Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito) Infection rate in mosquitoes by DSF measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito; and Infection rate in live wild-caught mosquitoes measured as the rate (per blood-fed mosquito) of malaria transmission (human to mosquito) Up to 3 years
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
Active, not recruiting NCT04704674 - Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
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 NCT02793414 - Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
Completed NCT02909712 - Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania Phase 2
Completed NCT02793622 - Prevention of Malaria in HIV-uninfected Pregnant Women and Infants Phase 3
Withdrawn NCT02793388 - A Trial on Supervised Primaquine Use in Ethiopia Phase 4
Completed NCT02527005 - A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients Phase 1