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

This study has been completed.
Sponsor:
Collaborators:
Institut Pasteur de Lille
Institut de Recherche pour le Developpement, Senegal
Institut de Recherche pour le Developpement
Université de Lille Nord de France
Région Nord-Pas de Calais, France
Center for Infection and Immunity of Lille, France
France: Centre National de la Recherche Scientifique
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Biomedical Research Center EPLS
ClinicalTrials.gov Identifier:
NCT01545115
First received: February 29, 2012
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

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.


Condition
Whooping Cough
Malaria
Malnutrition

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal

Resource links provided by NLM:


Further study details as provided by Biomedical Research Center EPLS:

Biospecimen Retention:   Samples Without DNA

Sera, culture supernatants


Enrollment: 410
Study Start Date: October 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)

Criteria

Inclusion Criteria:

  • Age: between 1 and 10 years

Exclusion Criteria:

  • Fever (body temperature superior to 38.5 °C)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545115

Locations
Senegal
Biomedical Research Center EPLS
Saint-Louis, Senegal, BP 56
Sponsors and Collaborators
Biomedical Research Center EPLS
Institut Pasteur de Lille
Institut de Recherche pour le Developpement, Senegal
Institut de Recherche pour le Developpement
Université de Lille Nord de France
Région Nord-Pas de Calais, France
Center for Infection and Immunity of Lille, France
France: Centre National de la Recherche Scientifique
Institut National de la Santé Et de la Recherche Médicale, France
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biomedical Research Center EPLS
ClinicalTrials.gov Identifier: NCT01545115     History of Changes
Other Study ID Numbers: EPLS08-JBS
Study First Received: February 29, 2012
Last Updated: March 12, 2012
Health Authority: Senegal: Ministere de la sante

Keywords provided by Biomedical Research Center EPLS:
Children
Immunity
Sub-Saharan
Pertussis
Malaria
Nutrition
antibodies

Additional relevant MeSH terms:
Malaria
Malnutrition
Nutrition Disorders
Whooping Cough
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Parasitic Diseases
Protozoan Infections
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 20, 2014