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

Malaria Clinical Trial

— AnoPalAnoVac  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01545115
• Other study ID #: EPLS08-JBS
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: March 12, 2012
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: March 2012
• Source: Biomedical Research Center EPLS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Senegal: Ministere de la sante
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 410
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Age: between 1 and 10 years

Exclusion Criteria:

• Fever (body temperature superior to 38.5 °C)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria
• Malnutrition
• Whooping Cough

Locations

Country	Name	City	State
Senegal	Biomedical Research Center EPLS	Saint-Louis

Sponsors (9)

Lead Sponsor	Collaborator
Biomedical Research Center EPLS	Centre d'Infection et d'Immunité de Lille, France: Centre National de la Recherche Scientifique, Institut de Recherche pour le Developpement, Institut de Recherche pour le Developpement, Senegal, Institut National de la Santé Et de la Recherche Médicale, France, Institut Pasteur de Lille, Région Nord-Pas de Calais, France, University of Lille Nord de France

Country where clinical trial is conducted

Senegal, 

References & Publications (1)

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. — View Citation

External Links

•   EPLS website