Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali
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ClinicalTrials.gov Identifier: NCT00471302 |
Recruitment Status
:
Recruiting
First Posted
: May 9, 2007
Last Update Posted
: April 20, 2018
|
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This study will determine the immune response to malaria infection in healthy volunteers compared with malaria patients. Malaria affects millions of people in Mali and Africa. It can cause fever, headaches, body aches, and weakness. Without treatment, the disease can be very serious in children. Developing an effective vaccine against the parasite that causes malaria is a crucial step toward controlling the disease; however, vaccines tested so far have provided very short-lived protection. A better understanding of the natural immunity to malaria may provide insight that can be applied to developing a more effective vaccine.
People 18 years of age or older who live in Kambila, Tieneguebougou or Kalifabougou, Mali, and are in good health may be eligible for this study.
Participants undergo a complete physical examination at the start of the study and then once a year for the 4-year duration of the study. They have a maximum of nine clinic visits a year to collect blood samples for research. The visits last about one hour, including a 30-minute observation time after the blood draw.
Condition or disease |
---|
Malaria |
Study Type : | Observational |
Estimated Enrollment : | 450 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Establishment of Normal Immunological Parameters Among Healthy Volunteers in Kambila, Tieneguebougou and Kalifabougou, Mali |
Study Start Date : | May 7, 2007 |

- Obtain blood samples from healthy Malian adults in order to establish normal immunologic parameters for this population and to optimize research assays performed at the MRTC. [ Time Frame: After enrollment, all volunteers will undergo a baseline medical history and physical examination, and will provide a blood sample for a malaria blood smear, and for a filter paper sample for P. falciparum polymerase chain reaction (PCR) analysis. ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
- Age 18 - 55 years
- Resident of Kambila, Tieneguebougou or Kalifabougou
- Adequate venous access
- Willingness to allow blood samples to be stored and used for future studies of the immune response to malaria
- Ability to give informed consent and willingness to comply with study requirements and procedures
EXCLUSION CRITERIA:
- Anemia (hemoglobin less than 11 g/dL).
- Currently taking antimalarials, corticosteroids or other immunosuppressants.
- Underlying heart disease, bleeding disorder, or other conditions that in the judgment of the Principal Investigator (PI) could increase the risk to the volunteer.
- Fever greater than or equal to 37.5 degrees Celsius or evidence of an acute infection.
- Current pregnancy, as determined by urine dipstick test for pregnancy.
- Participation in another clinical protocol that requires the administration of an experimental vaccine or experimental treatment.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471302
Contact: Peter D Crompton, M.D. | (301) 496-2959 | pcrompton@niaid.nih.gov |
Mali | |
University of Bamako, Faculty of Medicine, Pharmacy and Odontostomatology | Recruiting |
Bamako, Mali | |
Kalifabougou Health Center | Recruiting |
Kalifabougou, Mali | |
Tieneguebougou Health Center | Recruiting |
Tieneguebougou, Mali | |
Contact: Boubacar Traore, PharmD, PhD Not Listed Bouba.traore@icermali.org |
Principal Investigator: | Peter D Crompton, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00471302 History of Changes |
Other Study ID Numbers: |
999907141 07-I-N141 |
First Posted: | May 9, 2007 Key Record Dates |
Last Update Posted: | April 20, 2018 |
Last Verified: | October 2, 2017 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Healthy Volunteers Immunological Parameters Mali |
B Lymphocyte Malaria Healthy Volunteer |
Additional relevant MeSH terms:
Malaria Protozoan Infections Parasitic Diseases |