An observational study in Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 2 sites in 2 countries. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-24.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Observational
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.
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 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 TBVs have started elsewhere on the continent in Mali, and we expect to expand TBV studies in Guinea in the near future. This protocol will use a longitudinal cohort to gather information of malaria transmission based on the rates of blood smear positive individuals by month, season and year in at Maferinyah sub-prefecture, Guinea.
Individuals in the villages 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. Parasite infection rates in locally caught mosquitoes will be assessed longitudinally for differences by season and year. A total of 400 volunteers from Maferinyah will be enrolled. Participants will be followed for up to 3 years, to collect data that will guide the design of future community-based trials of TBV.
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
This study's enrollment of 400 is below the median of 582 across 204 observational studies indexed under Malaria.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
HOUSEHOLD INCLUSION CRITERIA:
To be eligible for participation, households must meet the following criteria:
SUBJECT EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy adults over the age of 19 years
Healthy children between the ages of 11 and 18 years
Healthy children between the ages of 5 and 10 years
Healthy infants between the ages of 6 months and four years
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
Time frame: Season and year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID) →