Normal Immunological Parameters Among Healthy Volunteers in Kambila, Mali

NCT00471302 | Completed

• 2 other identifiers: 99990714107-I-N141
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Immunology; Mali; Donor; Natural History

Outcome Measures

Primary Outcomes (1)

• Establishing immunological parameters

  Establishing immunological parameters in healthy malaria-exposed adults including phenotypic and functional measurements of dendritic cells, monocytes, NK cells, B cells and T cells

  Before and during the 6-month malaria season

Study Arms (1)

1

Healthy adults in a malaria endemic area in Mali

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults in a malaria endemic area in Mali

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• University of Bamako: collaborator

Study Sites (1)

U Mali Faculty Med Pharmacy & Dentistry IRB #1

Bamako, Mali

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Peter D Crompton, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: August 1, 2007
• Primary Completion: December 31, 2021
• Study Completion: May 23, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

MA (1)