NCT04704674

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
396

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 6, 2026

Enrollment Period

1.6 years

First QC Date

January 9, 2021

Last Update Submit

January 15, 2026

Conditions

Keywords

AssaysBLOOD SAMPLINGParasitesGametocyteInfectionNatural History

Outcome Measures

Primary Outcomes (1)

  • Measurement of Monthly rates of blood smear positive individuals by age

    Rate of blood smear positive individuals

    one year

Study Arms (4)

0.5 - 5 years

Age bracket for infants/children up to age five years

10 - 18 years

Age bracket for children 10 - 18 years

19 + years

Age bracket for adults over 19 years

5 - 10 years

Age bracket for children ages 5 - 10 years

Eligibility Criteria

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

An estimated total of 400 volunteers from Fleh-la and Marshansue and surrounding villages will be enrolled. Participants above the age of six months will be approached to participate in the study; and will be followed for up to 3 years.

You may qualify if:

  • months of age and above
  • Known resident of Fleh-la and Marshansue or the surrounding villages and planning to remain for duration of study
  • 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 who are not otherwise emancipated
  • To be eligible for participation, households must meet the following criteria:
  • Household with at least 3 residents eligible for participation.
  • Household with at least one compound member who is below 18 years of age 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Public Health Institute of Liberia (NPHIL)

Fleh-la, Liberia

Location

MeSH Terms

Conditions

MalariaInfections

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesMosquito-Borne DiseasesVector 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

January 9, 2021

First Posted

January 12, 2021

Study Start

September 30, 2021

Primary Completion

April 28, 2023

Study Completion

February 28, 2026

Last Updated

January 16, 2026

Record last verified: 2026-01-06

Data Sharing

IPD Sharing
Will not share

Locations