Status:

COMPLETED

Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

University of Bamako

Conditions:

Malaria

Eligibility:

All Genders

18-55 years

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, head...

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 o...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2007

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    May 23 2022

    Estimated Enrollment :

    310 Patients enrolled

    Trial Details

    Trial ID

    NCT00471302

    Start Date

    August 1 2007

    End Date

    May 23 2022

    Last Update

    June 1 2022

    Active Locations (1)

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    U Mali Faculty Med Pharmacy & Dentistry IRB #1

    Bamako, Mali