Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal (SchistoVAN)

This study has been completed.

Sponsor:

Collaborators:

Institut Pasteur de Lille

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:

NCT01553552

First received: March 12, 2012

Last updated: March 13, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 12, 2012

Last Updated Date

March 13, 2012

Start Date ^ICMJE

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01553552 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal

Official Title ^ICMJE

Comparison of Schistosomiasis Diagnostic Techniques and Study of Schistosoma Infection on Children's Immune Response to Childhood Vaccines, on Anaemia and on Nutritional Status

Brief Summary

SchistoVAN aims to study the role of schistosomiasis infection in the modulation of the immune response of children to childhood vaccine antigens, as well as the impact of this infection on their nutritional status and their haemoglobinaemia.

Detailed Description

SchistoVAN aims to study the interactions between chronic parasite infections such as schistosomiasis and the immunological and nutritional status of children. In this scope, the investigators conducted a case-control study where one group of children is infected with schistosoma haematobium and the other is not infected with this parasite.

The investigators then stimulated whole blood of these children with various vaccine antigens to address their immune function and study the influence of schistosomiasis infectious state on their overall immune condition.

Aims of the study:

To evaluate the interaction between schistosomiasis and the nutritional status of children and their haemoglobinemia.

To evaluate the influence of schistosomiasis on children's specific immune response towards EPI vaccine antigens, the inflammatory status of children and nutritional serologic markers.

To compare schistosomiasis diagnostic tools (evaluation of circulating cathodic antigen (CCA) strip for diagnosis of urinary schistosomiasis in comparison with microscopy and urinary dipsticks)

To study prevalence of intestinal parasites such as Blastocystis hominis

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Whole blood Sera Urine Stool

Sampling Method

Non-Probability Sample

Study Population

Residents of 3 villages from the Senegal Valley River, belonging to the Podor District in Saint-Louis Region in Northern Senegal: Agniam Towguel, Fanaye Diery and Niandane. Subcohort of a previous study "AnoPalAnoVac" (ClinicalTrials.gov ID: NCT01545115)

Condition ^ICMJE

Schistosomiasis
Anemia
Underweight
Stunting
Intestinal Parasites

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Infected by Schistosoma haematobium
Not infected by Schistosoma haematobium

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Members of AnoPalAnoVac cohort
Age: between 6 and 10 years

Exclusion Criteria:

body temperature > 38.5 ºC
malaria episode

Gender

Both

Ages

6 Years to 10 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Senegal

Administrative Information

NCT Number ^ICMJE

NCT01553552

Other Study ID Numbers ^ICMJE

EPLS11-MS

Has Data Monitoring Committee

Yes

Responsible Party

Biomedical Research Center EPLS

Study Sponsor ^ICMJE

Biomedical Research Center EPLS

Collaborators ^ICMJE

Institut Pasteur de Lille
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 ^ICMJE

Study Chair:	Emmanuel Hermann, PhD A.Pr.	Biomedical Research Center EPLS
Study Director:	Lobna Gaayeb, VetMed	Biomedical Research Center EPLS
Principal Investigator:	Modou Seck, MD	Biomedical Research Center EPLS

Information Provided By

Biomedical Research Center EPLS

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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