- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545115
Study of the Environmental Factors Modulating Children Immune Response in Northern Senegal (AnoPalAnoVac)
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Louis, Senegal, BP 56
- Biomedical Research Center EPLS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
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
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPLS08-JBS
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