Assessment of Biologic Parameters in Preparation for Future Malaria Vaccine Trials in Don gu Bougou, Mali
2 other identifiers
observational
515
1 country
1
Brief Summary
There are about 300-500 million cases of malaria worldwide each year, with 2-3 million deaths. Plasmodium falciparum, one of four types of malaria, is responsible for most of these deaths. Because of increasing resistance of this parasite to drugs and of mosquitoes to insecticides, a vaccine would be valuable in the fight against malaria. Don gu bougou, Mali, is an area of seasonal malaria transmission that is being investigated as a possible suitable site for testing investigational malaria vaccines. The goal of this study is to characterize the population of this site in terms of common hematologic (blood) and biochemistry parameters that may be used to determine eligibility for participation in vaccine trials. The study will also assess the prevalence of preexisting medical conditions that might affect assessments of vaccine safety and efficacy. Also, the natural immunity to antigens in the investigational malaria vaccines will be determined. Don gu bougou, Mali, was chosen because of its high malaria rates. Data will be collected at four time-points. At least 50 individuals will be recruited from each of the following age groups: 6 months-5 years; 6-10 years; 11-15 years; and 16-45 years. Village-wide consent will be obtained and about 25 of the 111 family compounds will be randomly selected. Individual consent will also be obtained. Enrolled volunteers will undergo a baseline medical history and physical examination. Blood will be collected for various tests, and, for women of childbearing age, urine pregnancy tests will be administered. At each of three followup visits, a brief medical history and physical exam will be conducted. Blood will be drawn for tests. Also, blood, urine, and/or stool tests not done at baseline will be done at one of the followup visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2002
Typical duration for all trials
1 active site
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
Study Start
First participant enrolled
July 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedJanuary 7, 2009
July 1, 2005
June 19, 2006
January 6, 2009
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Males or females aged 6 months to 45 years.
- Resident of Doneguebougou at the start of the study, and intent to remain a resident for the duration of the study.
- Willingness to participate in the study as evidenced by the completed informed consent document.
You may not qualify if:
- Clinical evidence of acute life-threatening illness requiring immediate medical care.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
June 19, 2006
First Posted
June 21, 2006
Study Start
July 1, 2002
Study Completion
July 1, 2005
Last Updated
January 7, 2009
Record last verified: 2005-07