NCT01160562

Brief Summary

Plasmodium falciparum malaria remains a global public health threat. Leading malaria vaccine candidates confer only partial short-lived protection at best. An understanding of the mechanisms by which humans acquire malaria immunity through repeated P. falciparum infections may aid the development of a malaria vaccine. This pilor study is designed to initiate the epidemiological groundwork for a future prospective cohort study of acquired malaria immunity in Kalifabougou, Mali, a rural village of approximately 5 000 individuals who are exposed to seasonal P. falciparum transmission each year from July through December. This study will estimate the age-stratified point prevalence of P. falciparum infection before the malaria season and at the peak of the 6-month malaria season, and it will estimate the age-stratified incidence of symptomatic p. falciparum infection during the 6-month malaria season. The spatial distribution of asymptomatic P. falciparum infections and incident malaria cases within the village of Kalifabougou will be determined by merging the prevalence and incidence data with census and Global Positioning System (GPS) data....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,719

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Typical duration 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

June 23, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2013

Completed
Last Updated

December 17, 2019

Status Verified

January 23, 2013

First QC Date

July 9, 2010

Last Update Submit

December 14, 2019

Conditions

Keywords

PrevalenceIncidenceChildrenAdultsGlobal Positioning system

Eligibility Criteria

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

You may qualify if:

  • Cross-sectional Survey:
  • Individuals (ages 2-25 years) are eligible to enter the cross-sectional study if they agree to:
  • Live in Kalifabougou for the next 5 months.
  • Have blood specimens stored for future studies.
  • Passive Surveillance:
  • All individuals who live in Kalifabougou and present to the Kalifabougou health center with suspected malaria will be eligible to enroll in the passive surveillance component of the protocol.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malaria Research and Training Center

Bamako, Mali

Location

Related Publications (3)

  • Vekemans J, Ballou WR. Plasmodium falciparum malaria vaccines in development. Expert Rev Vaccines. 2008 Mar;7(2):223-40. doi: 10.1586/14760584.7.2.223.

    PMID: 18324891BACKGROUND
  • Langhorne J, Ndungu FM, Sponaas AM, Marsh K. Immunity to malaria: more questions than answers. Nat Immunol. 2008 Jul;9(7):725-32. doi: 10.1038/ni.f.205.

    PMID: 18563083BACKGROUND
  • Crompton PD, Traore B, Kayentao K, Doumbo S, Ongoiba A, Diakite SA, Krause MA, Doumtabe D, Kone Y, Weiss G, Huang CY, Doumbia S, Guindo A, Fairhurst RM, Miller LH, Pierce SK, Doumbo OK. Sickle cell trait is associated with a delayed onset of malaria: implications for time-to-event analysis in clinical studies of malaria. J Infect Dis. 2008 Nov 1;198(9):1265-75. doi: 10.1086/592224.

    PMID: 18752444BACKGROUND

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan 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
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 9, 2010

First Posted

July 12, 2010

Study Start

June 23, 2010

Study Completion

January 23, 2013

Last Updated

December 17, 2019

Record last verified: 2013-01-23

Locations