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

NCT03304704 | Completed

• 2 other identifiers: 99991718017-I-N180
• Study Type: observational
• Target: 1,928
• Locations: 1 country
• Sites: 3

Brief 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. ...

Conditions

Malaria

Keywords

Assays; Direct Skin Feeds; Infection; Parasite; Gametocyte; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

DSF Cohort

Accrual/Screening up to 1800 will include volunteers between the ages of 5 and 17 years and will be enrolled for genotyping and monthly blood sampling

Genotype Cohort

Accrual/Screening up to 1500 will complete a single visit with blood draw for genotyping for future fidelity assessments with blood-fed, spray wild-caught mosquitoes.

Parasite Surveillance Cohort

Accrual/Screening up to 1500 will be enrolled for genotyping and a minimum of six monthly blood sampling and mosquito wild catches wild-caught mosquitoes within their compound

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Known resident of Bancoumana, Doneguebougou or the surrounding villages; and Willingness to allow stored laboratory specimens to be used for future research@@@@@@

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

Bancoumana Malaria Vaccine Center

Bamako, Mali

Location

Univ of Sciences, Techniques and Technology

Bamako, Mali

Location

Doneguebougou Facility

Donéguébougou, Mali

Location

Related Publications (3)

• 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.

  PMID: 9749648 BACKGROUND

• 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.

  PMID: 19055715 BACKGROUND

• 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.

  PMID: 16846756 BACKGROUND

MeSH Terms

Conditions

Malaria; Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Jennifer C Hume

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 9, 2017
• Study Start: January 28, 2018
• Primary Completion: July 12, 2020
• Study Completion: July 12, 2020
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

MA (3)