- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00346346
Analysis of the Immune Response to the Malaria Parasite in Mali, West Africa
Longitudinal Analysis of the B-Cell Immune Response to Plasmodium Falciparum in Mali
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 why immunity diminishes rapidly in the absence of ongoing infection. The results of this study may provide insight into whether and how natural immunity can be improved upon by vaccination.
Healthy people 2-4 and 18-25 years of age who live in the village of Kambila, Mali, may be eligible for this 1-year study. Participants have a small blood sample collected from a vein in the arm and also from two finger pricks at the beginning of the study, then every 2 months for 6 months and at the end of the study (for a total of five samples). People who become ill with malaria are evaluated and treated by a physician. Those recovering from their first episode of malaria during the study period have another blood sample collection and two finger pricks (bringing to six the total number of samples collected).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bamako, Mali
- Malaria Research and Training Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Principal Investigator: Peter D Crompton, M.D., National Institute of Allergy and Infectious Diseases (NIAID)
Publications and helpful links
General Publications
- Achidi EA, Perlmann H, Salimonu LS, Perlmann P, Walker O, Asuzu MC. A longitudinal study of seroreactivities to Plasmodium falciparum antigens in Nigerian infants during their first year of life. Acta Trop. 1995 May;59(2):173-83. doi: 10.1016/0001-706x(95)00076-q.
- ALLISON AC. Protection afforded by sickle-cell trait against subtertian malareal infection. Br Med J. 1954 Feb 6;1(4857):290-4. doi: 10.1136/bmj.1.4857.290. No abstract available.
- ALLISON AC. Glucose-6-phosphate dehydrogenase deficiency in red blood cells of East Africans. Nature. 1960 May 14;186:531-2. doi: 10.1038/186531a0. No abstract available.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999906147
- 06-I-N147
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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