NCT04650815

Brief Summary

Background: Malaria is a disease that affects many people in Burkina Faso. It is caused by germs that are spread by mosquito bites. A vaccine that blocks the spread of malaria is important to get rid of the disease. To see if a vaccine works, researchers need to find out how many malaria infections are happening in the community. Objective: To learn how often people of all ages who live in Sabou, Burkina Faso, get malaria. Eligibility: Healthy people ages 6 months to 65 years who reside in Sabou in a household with adults and children. Design: Participants will be screened with questions about their health. They will have a physical exam. Participants will be asked about any malaria symptoms they are having. They will be asked about the use of bed nets. Their vital signs, like blood pressure and temperature, will be measured. They will have blood taken from their arm with a needle. Participants who have a fever will have a malaria test. Those who test positive for malaria will be referred to the local health facility for treatment. Participants will have monthly study visits. Blood will be taken from a finger. Participants may be invited to take part in 2 mosquito feeding experiments. Mosquitos that do not carry malaria will bite their arm. And a small amount of blood will be fed to mosquitos in a laboratory. Participants' homes will be examined for mosquitoes. Researchers will remove all mosquitoes they collect. Participants' homes will be sprayed with a chemical to kill mosquitoes and other insects. Participation will last for 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
608

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2024

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

December 2, 2020

Last Update Submit

March 27, 2026

Conditions

Keywords

AssaysBLOOD SAMPLINGParasitesGametocyteInfectionNatural History

Outcome Measures

Primary Outcomes (1)

  • Measurement of blood smear positive individuals by age over the course of one year. These estimates will be stratified by age brackets of transmission interest (0.5-5, 5-10, 10-18, 19+ years old)

    Monthly rates of blood smear positive individuals by age over the course of one year

    one year

Study Arms (4)

0.5 - 5 Years

Infants and Children up to age 5 years in the Sabou Health District

10 - 18 Years

Children ranging in age 10 to 18 years in the Sabou Health District

19 + Years

Adults ranging in ages 19 years to 65 years in the Sabou Health District

5 - 10 Years

Children ranging in age 5 years through 10 years in the Sabou Health District

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Up to 900 volunteers (ages 0.5 - 65 years) from Sabou Health District area will be recruited for this study.

You may qualify if:

  • Household with at least 3 residents eligible for participation.
  • Household with at least one compound member who is below 5 years of age whose parents or caretakers are willing to provide informed consent for the child to participate
  • Household with at least one compound member aged 5-15 years whose parents or caretakers are willing to provide informed consent for the child to participate
  • Household members willing to accommodate mosquito sampling in their compound, both indoors and outdoors.
  • to 65 years of age
  • Known resident within the study area and planning to remain for the duration of the study
  • Acceptance and signature of the written informed consent and the assent for children aged 12-19 years who are not otherwise emancipated

You may not qualify if:

  • Major congenital defect diagnosed based on medical history and examination
  • 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.
  • Current participation in malaria vaccine trials or participation in such trials in the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CMAMK

Sabou, Burkina Faso

Location

GRAS

Sabou, Burkina Faso

Location

MeSH Terms

Conditions

MalariaInfections

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Patrick E Duffy, M.D.

    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

December 2, 2020

First Posted

December 3, 2020

Study Start

June 10, 2021

Primary Completion

June 25, 2024

Study Completion

June 25, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data because collected data will be used to guide the design of future community-based trials of TBV.

Locations