Status:
COMPLETED
Analysis of the Immune Response to the Malaria Parasite in Mali, West Africa
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
2-25 years
Brief Summary
This study will examine the immune response to the malaria parasite at the cellular level to better understand why people achieve natural immunity to the parasite only after multiple infections and wh...
Detailed Description
Malaria remains an important public health threat, responsible for over one million deaths annually, the majority among African children. The development of a safe and effective vaccine is widely rega...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - HEALTHY VOLUNTEERS AT ENROLLMENT:
- Males and females ages 2 to 10 years or 18 to 25 years.
- Will be living in Kambila for one year and available for 12 month follow-up.
- Willing to have blood specimens stored.
- Willingness of adult volunteer to participate in the study as evidenced by the completed informed consent document.
- Willingness of parent or guardian to have his or her child participate in the study as evidenced by the completed informed consent document.
- EXCLUSION CRITERIA - HEALTHY VOLUNTEERS AT ENROLLMENT:
- Active bleeding or hematocrit less than or equal to 15 % (for both children and adults).
- Fever greater than 38 degrees C, or systemic illness at enrollment.
- Currently using anti-malarial medications.
- The following two exclusion items may not have occurred in the last 30 days: participation in a vaccine or drug trial, or use of corticosteroid or other immunosuppressive drugs.
- Current pregnancy or a plan to become pregnant during the one year study period. Pregnancy status will be determined at enrollment by urine dipstick, and at subsequent time points by self-report only.
- While on this protocol, if a subject enrolls in another study that requires the administration of experimental therapies (vaccines or medications), he/she may no longer participate in this protocol.
- (Presence of P. falciparum parasitemia in the absence of symptoms at the time of screening is not exclusionary).
Exclusion
Key Trial Info
Start Date :
April 17 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 23 2013
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT00346346
Start Date
April 17 2006
End Date
January 23 2013
Last Update
December 5 2019
Active Locations (1)
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1
Malaria Research and Training Center
Bamako, Mali