Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation)

Completed

• Conditions: Acute Gastroenteritis; Gastroenteritis
• Interventions: Biological: rotavirus rapid screen test; Genetic: polymorphism exploration

• Registration Number: NCT02902445
• Lead Sponsor: Nantes University Hospital

Brief Summary

The GASTROVIM research explores the links between individual genetic susceptibility, genetic variability of rotavirus strains and effectiveness of immunization with the rotavirus vaccination: a clinical investigation to assess glycan attachment specificity, toward rotavirus vaccine improvement.

Detailed Description

The work will be carried out in France and in a tropical area of population with diverse geographical origins: the Guyana populated with Native Americans, people of European descent, people of Asian (Hmong) and a large source population African.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-15
• Study Start: 2017-02-28
• Primary Completion: 2020-10-15
• Study Completion: 2020-10-15
• Status Verified: 2021-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 611

Inclusion Criteria

• 0 to 16.
• 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)

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Exclusion Criteria

• case group: rotavirus rapid screen test negative; viral gastroenteritis other than rotavirus; bacterial gastroenteritis
• control group: Family and / or patient unable to full informed consent to research; Infectious Pathology context in general.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case group	rotavirus rapid screen test	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
Case group	polymorphism exploration	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
Control group	polymorphism exploration	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

Primary Outcome Measures

Name	Time	Method
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-	6 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Population frequency of new protective genotypes to rotavirus infection	Six months after inclusion
Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)	Six months after inclusion
Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana	Six months after inclusion
Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana	Six months after inclusion
population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)	Six months after inclusion

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France