Clinical trial NCT01545115: Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal
Official title: Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whooping Cough
Malaria
Malnutrition
Keywords: Children
Immunity
Sub-Saharan
Pertussis
Malaria
Nutrition
antibodies
Lead sponsor: Biomedical Research Center EPLS
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
name: Institut de Recherche pour le Developpement, Senegal
name: Institut de Recherche pour le Developpement
name: University of Lille Nord de France
name: Région Nord-Pas de Calais, France
name: Centre d'Infection et d'Immunité de Lille
name: Centre National de la Recherche Scientifique, France
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-03-06
Enrollment: 410
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: 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: 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 criteria: Inclusion Criteria:

* Age: between 1 and 10 years

Exclusion Criteria:

* Fever (body temperature superior to 38.5 °C)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Louis
country: Senegal
facility: Biomedical Research Center EPLS
Study officials:
affiliation: Biomedical Research Center EPLS
name: Franck Remoué, PhD
role: STUDY_CHAIR
affiliation: Biomedical Research Center
name: Emmanuel Hermann, PhD A. Pr.
role: STUDY_DIRECTOR
affiliation: Biomedical Research Center EPLS
name: Jean Biram Sarr, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biomedical Research Center EPLS
name: Lobna Gaayeb, VetMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.