Community Dynamics of Malaria Transmission in Humans and Mosquitoes at Maferinyah Sub-Prefecture, Guinea

NCT04969913 | Completed

• 2 other identifiers: 10000160000160-I
• Study Type: observational
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief Summary

Background: Half of the world s population is at risk of malaria. In 2015, there were 214 million cases of malaria and 438,000 deaths. A transmission-blocking vaccine (TBV) could help end the disease. Improved tests are needed to measure how well the vaccines work. Researchers want to collect data about malaria infection as the first step in testing a TBV in rural Guinea. Objective: To study community dynamics of malaria transmission by estimating the rate of blood smear positive people by month and season. Eligibility: People 6 months of age and older who live in Maf(SqrRoot)(Registered Trademark)rinyah sub-prefecture and plan to remain during the study. Households with at least 3 people who are eligible to take part in the study are also needed. Design: Participants will be screened with a medical and medicine history. They will have a physical exam. Their height and weight will be measured. Their vital signs may be taken. Participants will have a study visit each month for up to 3 years. They will get a study ID. They will be asked about any symptoms of malaria or changes in health. They will give blood samples. They may have a physical exam. Within 3 days of the study visits, live and dead mosquitoes may be gathered in and around their home. Insecticide spray will be used. Participants can visit the clinic at any time if they feel ill. If they have malaria, they will be treated according to Guinea National Malaria Control Guidelines for adults and children.

Conditions

Malaria

Keywords

Assays; BLOOD SAMPLING; Parasites; Gametocytes; Infection; Natural History

Outcome Measures

Primary Outcomes (1)

• To study community dynamics of malaria transmission by estimating the rate of blood smear positive individuals by month and season stratified by age

  Rate of blood smear positive individuals by month and season stratified by age

  Season and year

Study Arms (4)

19 + years

Healthy adults over the age of 19 years

Ages 11 - 18 years

Healthy children between the ages of 11 and 18 years

Ages 5 - 10 years

Healthy children between the ages of 5 and 10 years

Ages 6 months - 4 years

Healthy infants between the ages of 6 months and four years

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Guinean infants, children, and adults (any age) from Maferinyah sub-prefecture. Maferinyah is a town and sub-prefecture in the Forecariah Prefecture in the Kindia Region of western Guinea. Maferinyah is located about 50 kms directly to the west (and 75 kms by paved road) of Conakry, the capital city of Guinea

You may qualify if:

• months of age and above
• Known resident of Maferinyah sub-prefecture 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.

Sponsors & Collaborators

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

Study Sites (2)

Immunology and Pathogenesis Laboratories

Bethesda, Maryland, 20892, United States

Location

Maferinyah Rural Health Training and Research Center

Maferinyah, Guinea

Location

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: July 20, 2021
• First Posted: July 21, 2021
• Study Start: March 7, 2022
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GU (1); US (1)