Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Detailed Description:

Malaria results in at least 2.7 million deaths per year, the majority among African children. The development of a vaccine against Plasmodium falciparum is regarded as a crucial step toward control of this disease. Unfortunately, vaccine candidates have resulted in short-lived protection at best. The ineffectiveness of current vaccines may reflect the kinetics of naturally acquired immunity to malaria in that multiple infections are required over years before partial protection is achieved and then immunity is lost, or becomes less effective, in the absence of recurrent infection. The mechanisms underlying the delayed acquisition and presumably rapid loss of humoral immunity are poorly understood. A more detailed understanding of these processes at the cellular level may be important for vaccine development. We are currently studying the cellular basis of humoral immunity to P. falciparum through research collaboration between the Malaria Research and Training Center (MRTC) in Bamako, Mali and the National Institutes of Health (NIH) in the United States. This protocol supports that research by ensuring a supply of 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.

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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. ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

• 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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Peter D Crompton, M.D.	(301) 496-2959	pcrompton@niaid.nih.gov

Locations

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

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

University of Bamako

Investigators

Principal Investigator:	Peter D Crompton, M.D.	National Institute of Allergy and Infectious Diseases (NIAID)

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Ballou WR, Arevalo-Herrera M, Carucci D, Richie TL, Corradin G, Diggs C, Druilhe P, Giersing BK, Saul A, Heppner DG, Kester KE, Lanar DE, Lyon J, Hill AV, Pan W, Cohen JD. Update on the clinical development of candidate malaria vaccines. Am J Trop Med Hyg. 2004 Aug;71(2 Suppl):239-47. Review.

Breman JG. The ears of the hippopotamus: manifestations, determinants, and estimates of the malaria burden. Am J Trop Med Hyg. 2001 Jan-Feb;64(1-2 Suppl):1-11. Review.

Crotty S, Felgner P, Davies H, Glidewell J, Villarreal L, Ahmed R. Cutting edge: long-term B cell memory in humans after smallpox vaccination. J Immunol. 2003 Nov 15;171(10):4969-73.

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
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