Preventing the Spread of Malaria in Mali
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Purpose
Background:
- The Malaria Research and Training Center in Mali is involved in research to make a malaria vaccine. The vaccine is being designed to help interrupt the spread of malaria. Researchers want to study the different tests that can determine whether these vaccines will block the development of malaria parasites in the mosquito. To help develop these vaccines, researchers are studying children and adults from a village in Mali. They want to see whether the area will be a good place to test the malaria blocking vaccine in the future.
Objectives:
- To study different tests of malaria spread and malaria blocking vaccines.
- To see how many people in the Mali village have malaria parasites in their blood that can infect other people.
Eligibility:
- Healthy people between 3 months and 50 years of age who live in a Mali village.
Design:
- Participants will have a physical exam and medical history. They will give a blood sample that will be tested for malaria parasites. Participants who have malaria in the blood that can be transmitted to others will have more blood tests.
- All participants will have regular blood tests and checkups to see if malaria parasites have grown. Their response to malaria infections and treatments will also be tested.
- Participants at least 5 years of age will have tests that involve being bitten by laboratory-grown mosquitoes. These insects have never been infected with malaria or other diseases. Researchers will study the effectiveness of different vaccines meant to block the spread of malaria.
- Researchers may collect mosquitoes from participants' houses to see if these mosquitoes have bitten someone nearby. They will try to learn more about what makes mosquitoes more likely to become infected with malaria when they bite someone. Researchers may also map the house to study the areas where malaria infection is more common.
- Participants will be followed for up to 1 year.
| Condition |
|---|
|
Malaria |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Malaria Transmission Blocking Assay Development and Gametocyte Carriage in a Vaccine Testing Site in Mali |
| Estimated Enrollment: | 1000 |
| Study Start Date: | April 2011 |
A vaccine which interrupts malaria transmission is a critical tool to achieve the ultimate goal of eradication of this disease. Transmission blocking vaccines work by inducing antibody in vaccinated individuals that inhibits the development of malaria parasites in the mosquito, thus interrupting the cycle of transmission to the next human host. Efficacy of these vaccines may be estimated by in vitro membrane feeding assays using immune sera and laboratory strain mosquitoes, but these assays need to be qualified to determine to what extent they are predictive of transmission blocking in the field. Clinical trials of transmission blocking vaccines are also anticipated, and data are needed to determine target populations and sample sizes. This protocol will use a nested case-control cohort design to compare results of mosquito feeding assays in a malaria exposed population in Bancoumana, Mali. Households will be identified using census data and individuals will be consented for participation. Up to 250 volunteers, ages 3 months to 50 years, will be enrolled. Malaria smears will be obtained at monthly visits, and gametocytemic individuals and age-matched gametocyte negative individuals will be asked to participate in direct feed experiments using insectary-raised mosquitoes. Infectivity in these mosquitoes will be compared against those of mosquitoes fed in membrane feeding assays in Mali and the USA. Data will also be obtained on gametocyte carriage rates through the year. An expanded cohort of adults will be enrolled in 2012. A transmission blocking vaccine trial planned to start in January 2013 will enroll participants from the adult cohort in this study.
Eligibility| Ages Eligible for Study: | 3 Months to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
All of the following criteria must be fulfilled for a volunteer to participate in the study:
- Age between 3 months and 50 years, inclusive
- Good general health as a result of review of medical history and/or clinical testing at the time of screening
- Available for the duration of the study (1 year)
- Willingness to participate in the study as evidenced by signing the informed consent document, or by fingerprinting the consent document with the signature of a witness
- Known resident of the village of the study
- Willingness to allow stored laboratory specimens to be used for future research.
- In addition to the above criteria, the expanded adult cohort must be willing to participate in a Phase 1b vaccine trial.
EXCLUSION CRITERIA:
A volunteer will be excluded from participating in this study if any one of the following criteria is fulfilled:
- Pregnancy as determined by history or a positive urine Beta-hCG test at any point during the study.
- 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.
- Participation in another investigational vaccine or drug trial while this study is ongoing.
- Previous receipt of experimental malaria vaccine.
Baseline hemoglobin < 8.5 g/dL
In addition to above criteria, a volunteer will be excluded from participating in the transmission blocking assay part of the study if the following criteria is fulfilled:
- History of reactions to mosquito bites with severe itching or swelling, or lasting longer than 3 days
Contacts and Locations| Mali | |
| University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology | |
| Bamako, Mali | |
| Principal Investigator: | Yimin Wu, Ph.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT01360112 History of Changes |
| Other Study ID Numbers: | 999911143, 11-I-N143 |
| Study First Received: | May 20, 2011 |
| Last Updated: | January 25, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Mosquito Membrane Feeding |
Parasites Infection Malaria |
Additional relevant MeSH terms:
|
Malaria Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013