Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation)
NCT ID: NCT02902445
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
611 participants
OBSERVATIONAL
2017-02-28
2020-10-15
Brief Summary
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Detailed Description
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The first aim of the project will be to characterize the specificity of the VP8 \* HBGA of RotaTeq and Rotarix vaccines in order to ensure their binding characteristics glycans are similar to those of recent P8 clinical strains circulating in France and were maintained in the culture passages.
The second objective will be to validate the impact of recently described polymorphisms HBGAs on susceptibility to infection by RVA through GASTROVIMc prospective clinical research.
The third objective will be to determine the relative role of recognition and HBGAs ganglioside in the initial attachment and viral entry.
The expression of HBGAs and ganglioside by permissive cell lines in culture human stem RVA be manipulated to define the role of glycans in attachment and infection.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case group
250 children from Nantes University Hospital and 150 children from Guyana Hospital admitted in paediatric emergency unit for diagnosed rotavirus acute gastroenteritis: rotavirus rapid screen test and oral swab for polymorphism exploration
rotavirus rapid screen test
According to routine care
polymorphism exploration
from an oral swab collected after parents consent
Control group
250 children from Nantes University Hospital and 150 children from Guyana Hospital admitted in paediatric emergency unit without signs of infection and / or digestive clinical picture evocative of gastroenteritis.
Paired with a case upon ethnicity or origin if impossible to match the ethnicity of the case.
oral swab for polymorphism exploration
polymorphism exploration
from an oral swab collected after parents consent
Interventions
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rotavirus rapid screen test
According to routine care
polymorphism exploration
from an oral swab collected after parents consent
Eligibility Criteria
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Inclusion Criteria
* giving consent to participate if applicable (\>6yo)
* Parents informed and written consent obtained
* admitted in paediatric emergency for wether an acute gastroenteritis (case group) or anything else than an infection or gastroenteritis (control group)
Exclusion Criteria
* control group: Family and / or patient unable to full informed consent to research; Infectious Pathology context in general.
16 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Christèle GRAS-LEGUEN, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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Nantes University Hospital
Nantes, Loire-Atlantique, France
Countries
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Other Identifiers
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RC15_0329
Identifier Type: -
Identifier Source: org_study_id
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