Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
University of Bamako
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00471302
First received: May 8, 2007
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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, 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
Malaria

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Establishment of Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 280
Study Start Date: May 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Age 18 - 55 years.

Resident of Kambila.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471302

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
Kambila Health Center Recruiting
Kambila, Mali
Sponsors and Collaborators
University of Bamako
Investigators
Principal Investigator: Peter D Crompton, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00471302     History of Changes
Other Study ID Numbers: 999907141, 07-I-N141
Study First Received: May 8, 2007
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Healthy Volunteers
Immunological Parameters
Mali
B Lymphocyte
Malaria
Healthy Volunteer

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on July 24, 2014