SchistosomiasisSchistoVANNCT01553552
Schistosomiasis Effect on Response to Vaccines, Anaemia and Nutritional Status of Children of Northern Senegal
An observational study of Schistosomiasis and Anemia, run by Biomedical Research Center EPLS at 1 site in Senegal.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Schistosomiasis, Anemia, Underweight
- How many people
- 99 participants
- Where
- 1 siteSenegal
- Study dates
- Oct 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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)
Who may be able to join
- Members of AnoPalAnoVac cohort
- Age: between 6 and 10 years
Who cannot join
- body temperature > 38.5 ºC
- malaria episode
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Schistosomiasis Diagnostic Techniques and Study of Schistosoma Infection on Children's Immune Response to Childhood Vaccines, on Anaemia and on Nutritional Status
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.
Read the 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
- Conditions
- Schistosomiasis, Anemia, Underweight, Stunting, Intestinal Parasites
- Keywords
- Schistosoma haematobium, schistosoma mansoni, Anemia, Underweight, stunting, Blastocystis
- Medical subject headings
- Schistosomiasis, Anemia, Thinness, Growth Disorders, Intestinal Diseases, Parasitic, Schistosomiasis haematobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infected by Schistosoma haematobium | Not described | |
| Not infected by Schistosoma haematobium | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchistosomiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomedical Research Center EPLS
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur de Lille, University of Lille Nord de France, Région Nord-Pas de Calais, France, Centre d'Infection et d'Immunité de Lille, Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Emmanuel Hermann, PhD A.Pr., Study chair, Biomedical Research Center EPLSLobna Gaayeb, VetMed, Study director, Biomedical Research Center EPLSModou Seck, MD, Principal investigator, Biomedical Research Center EPLS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553552
- Sponsor's protocol ID
- EPLS11-MS
- Acronym
- SchistoVAN
- Status last verified
- Mar 2012
- First submitted
- 12 Mar 2012
- Last updated
- 14 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hermann E, Gaayeb L, Sow PS, Seck M, Sagna AB, Senghor S, Bandagny L, Brinkhuizen C, Delcroix-Genete D, Schacht AM, Riveau G. Sex-dependent interactions between leptin, wasting and humoral immunity in two ethnic communities of school-aged children differentially exposed to Schistosoma haematobium. Trans R Soc Trop Med Hyg. 2017 Oct 1;111(10):448-456. doi: 10.1093/trstmh/trx078.
PubMed 29351649
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Schistosomiasis Diagnostic Techniques and Study of Schistosoma Infection on Children's Immune Response to Childhood Vaccines, on Anaemia and on Nutritional Status
- ClinicalTrials.gov ID
- NCT01553552
- Acronym / sponsor ID
- SchistoVAN / EPLS11-MS
- Conditions
- Schistosomiasis, Anemia, Underweight, Stunting, Intestinal Parasites
- Keywords
- Schistosoma haematobium, schistosoma mansoni, Anemia, Underweight, stunting, Blastocystis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Biomedical Research Center EPLSUniversity, hospital or other
- Collaborators
- Institut Pasteur de Lille, University of Lille Nord de France, Région Nord-Pas de Calais, France, Centre d'Infection et d'Immunité de Lille, Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infected by Schistosoma haematobium | – | – |
| Not infected by Schistosoma haematobium | – | – |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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)
Key inclusion criteria (2 listed)
- Members of AnoPalAnoVac cohort
- Age: between 6 and 10 years
Key exclusion criteria (2 listed)
- body temperature > 38.5 ºC
- malaria episode
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Derived from this study: PubMed 29351649Hermann E, Gaayeb L, Sow PS, Seck M, Sagna AB, Senghor S, Bandagny L, Brinkhuizen C, Delcroix-Genete D, Schacht AM, Riveau G. Sex-dependent interactions between leptin, wasting and humoral immunity in two ethnic communities of school-aged children differentially exposed to Schistosoma haematobium. Trans R Soc Trop Med Hyg. 2017 Oct 1;111(10):448-456. doi: 10.1093/trstmh/trx078.
- EPLS websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Hermann, PhD A.Pr. study chair
Biomedical Research Center EPLS
Lobna Gaayeb, VetMed study director
Biomedical Research Center EPLS
Modou Seck, MD principal investigator
Biomedical Research Center EPLS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schistosomiasis and Anemia, run by Biomedical Research Center EPLS at 1 site in Senegal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553552, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.