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

March 12, 2012 updated by: Biomedical Research Center EPLS

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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Saint-Louis, Senegal, BP 56
        • Biomedical Research Center EPLS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Residents of 5 villages from the Senegal Valley River, belonging to the Podor District in Saint-Louis Region in Northern Senegal.

Agniam (16°32'N-14°48'W; total population (TP): 989; several temporary ponds, traditional housing, irrigated crops) Fanaye Diery (16°32'N-15°13'W; TP: 6781; animal husbandry, irrigated crops, some urbanized habitat) Niandane (16°35'N-14°59'W; TP: 5100; Rice and banana farming, irrigated crops, some urbanized habitat) Ndiayène Pendao (16°30'N- 15°03'W; TP: 2734; animal husbandry, Savannah surroundings) Guédé Village (16°33'N-14°48'W; TP:3005; Traditional housing, irrigated crops)

Description

Inclusion Criteria:

  • Age: between 1 and 10 years

Exclusion Criteria:

  • Fever (body temperature superior to 38.5 °C)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Franck Remoué, PhD, Biomedical Research Center EPLS
  • Study Director: Emmanuel Hermann, PhD A. Pr., Biomedical Research Center
  • Principal Investigator: Jean Biram Sarr, PhD, Biomedical Research Center EPLS
  • Principal Investigator: Lobna Gaayeb, VetMed, Biomedical Research Center EPLS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 13, 2012

Last Update Submitted That Met QC Criteria

March 12, 2012

Last Verified

March 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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