Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal

NCT ID: NCT01545115

Last Updated: 2012-03-13

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

410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-02-28

Brief Summary

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Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria.

A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children.

Detailed Description

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Longitudinal survey in Northern Senegal to investigate the environmental factors modulating the immune response to childhood vaccines and to malaria.

A cohort of 410 children aged 1 to 10 from 5 villages of the Senegal River Valley(Podor District) was followed-up for 18 months. During that period, 5 visits have been made to the villages to assess the immunological and nutritional status of the children (T1 (October 2008), T2 (January 2009), T3 (June 2009), T4 (October 2009) and T5 (January 2010)).

The project was approved by the National Ethics Committee of Senegal. Written individual informed consent was obtained from each participant's parent or legal guardian at the beginning of the survey, and at each visit child's and parent's approval was sought orally.

Capillary blood was collected from the finger tip of each child, using sterile single-use material.

Body temperature was measured by means of auricular thermometer at all visits. Anthropomorphic data were collected at visits T2, T3, T4 and T5.

A Hemocue photometer (HemoCue AB, Ängelholm, Sweden) was used to determine haemoglobin concentration on a blood drop at visits T3, T4 and T5.

At each visit, a questionnaire was filled in for every child. Information was collected on the date of birth family membership to asses if siblings or children living in the same house were in the cohort.

Conditions

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Whooping Cough Malaria Malnutrition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age: between 1 and 10 years

Exclusion Criteria

* Fever (body temperature superior to 38.5 °C)
Minimum Eligible Age

1 Year

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur de Lille

OTHER

Sponsor Role collaborator

Institut de Recherche pour le Developpement, Senegal

OTHER

Sponsor Role collaborator

Institut de Recherche pour le Developpement

OTHER_GOV

Sponsor Role collaborator

University of Lille Nord de France

OTHER

Sponsor Role collaborator

Région Nord-Pas de Calais, France

OTHER

Sponsor Role collaborator

Centre d'Infection et d'Immunité de Lille

OTHER

Sponsor Role collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Biomedical Research Center EPLS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franck Remoué, PhD

Role: STUDY_CHAIR

Biomedical Research Center EPLS

Emmanuel Hermann, PhD A. Pr.

Role: STUDY_DIRECTOR

Biomedical Research Center

Jean Biram Sarr, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Center EPLS

Lobna Gaayeb, VetMed

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Center EPLS

Locations

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Biomedical Research Center EPLS

Saint-Louis, Saint-Louis, Senegal

Site Status

Countries

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Senegal

References

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Ndiath MO, Sarr JB, Gaayeb L, Mazenot C, Sougoufara S, Konate L, Remoue F, Hermann E, Trape JF, Riveau G, Sokhna C. Low and seasonal malaria transmission in the middle Senegal River basin: identification and characteristics of Anopheles vectors. Parasit Vectors. 2012 Jan 23;5:21. doi: 10.1186/1756-3305-5-21.

Reference Type BACKGROUND
PMID: 22269038 (View on PubMed)

Gaayeb L, Pincon C, Cames C, Sarr JB, Seck M, Schacht AM, Remoue F, Hermann E, Riveau G. Immune response to Bordetella pertussis is associated with season and undernutrition in Senegalese children. Vaccine. 2014 Jun 5;32(27):3431-7. doi: 10.1016/j.vaccine.2014.03.086. Epub 2014 Apr 14.

Reference Type DERIVED
PMID: 24726248 (View on PubMed)

Related Links

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Other Identifiers

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EPLS08-JBS

Identifier Type: -

Identifier Source: org_study_id

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