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Pilot Study to Estimate the Burden and Distribution of Plasmodium Falciparum Malaria in Kalifabougou, Mali in Preparation for a Prospective Cohort Study of Naturally-Acquired Malaria Immunity

NCT ID: NCT01160562

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1719 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-23

Study Completion Date

2013-01-23

Brief Summary

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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....

Detailed Description

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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.

Conditions

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Malaria, Falciparum Plasmodium Falciparum

Keywords

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Prevalence Incidence Children Adults Global Positioning system

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

None.
Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role lead

Principal Investigators

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Peter D Crompton, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Locations

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Malaria Research and Training Center

Bamako, , Mali

Site Status

Countries

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Mali

References

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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.

Reference Type BACKGROUND
PMID: 18324891 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18563083 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18752444 (View on PubMed)

Other Identifiers

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10-I-N155

Identifier Type: -

Identifier Source: secondary_id

999910155

Identifier Type: -

Identifier Source: org_study_id