NCT00346346

Brief Summary

This study will examine the immune response to the malaria parasite at the cellular level to better understand why people achieve natural immunity to the parasite only after multiple infections and why immunity diminishes rapidly in the absence of ongoing infection. The results of this study may provide insight into whether and how natural immunity can be improved upon by vaccination. Healthy people 2-4 and 18-25 years of age who live in the village of Kambila, Mali, may be eligible for this 1-year study. Participants have a small blood sample collected from a vein in the arm and also from two finger pricks at the beginning of the study, then every 2 months for 6 months and at the end of the study (for a total of five samples). People who become ill with malaria are evaluated and treated by a physician. Those recovering from their first episode of malaria during the study period have another blood sample collection and two finger pricks (bringing to six the total number of samples collected).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 17, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2006

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2013

Completed
Last Updated

December 5, 2019

Status Verified

January 23, 2013

First QC Date

June 28, 2006

Last Update Submit

December 4, 2019

Conditions

Keywords

ImmunityMemoryELISPOTMalariaProspective

Eligibility Criteria

Age2 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males and females ages 2 to 10 years or 18 to 25 years.
  • Will be living in Kambila for one year and available for 12 month follow-up.
  • Willing to have blood specimens stored.
  • Willingness of adult volunteer to participate in the study as evidenced by the completed informed consent document.
  • Willingness of parent or guardian to have his or her child participate in the study as evidenced by the completed informed consent document.

You may not qualify if:

  • Active bleeding or hematocrit less than or equal to 15 % (for both children and adults).
  • Fever greater than 38 degrees C, or systemic illness at enrollment.
  • Currently using anti-malarial medications.
  • Current pregnancy or a plan to become pregnant during the one year study period. Pregnancy status will be determined at enrollment by urine dipstick, and at subsequent time points by self-report only.
  • While on this protocol, if a subject enrolls in another study that requires the administration of experimental therapies (vaccines or medications), he/she may no longer participate in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

  • Achidi EA, Perlmann H, Salimonu LS, Perlmann P, Walker O, Asuzu MC. A longitudinal study of seroreactivities to Plasmodium falciparum antigens in Nigerian infants during their first year of life. Acta Trop. 1995 May;59(2):173-83. doi: 10.1016/0001-706x(95)00076-q.

    PMID: 7676908BACKGROUND
  • ALLISON AC. Protection afforded by sickle-cell trait against subtertian malareal infection. Br Med J. 1954 Feb 6;1(4857):290-4. doi: 10.1136/bmj.1.4857.290. No abstract available.

    PMID: 13115700BACKGROUND
  • ALLISON AC. Glucose-6-phosphate dehydrogenase deficiency in red blood cells of East Africans. Nature. 1960 May 14;186:531-2. doi: 10.1038/186531a0. No abstract available.

    PMID: 13792821BACKGROUND

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Peter D Crompton, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 28, 2006

First Posted

June 29, 2006

Study Start

April 17, 2006

Study Completion

January 23, 2013

Last Updated

December 5, 2019

Record last verified: 2013-01-23

Locations