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

Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation) Evaluation of Individual Genetic Susceptibility in Severe Gastro-enteritis Rotavirus: Role of HBGA Polymorphisms & Biotechnology Improvement of RVA Vaccines

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.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis; Acute Gastroenteritis
• Intervention / Treatment: Biological: rotavirus rapid screen test; Genetic: polymorphism exploration

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.

• Study Type: Observational
• Enrollment (Actual): 611

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

400 children admitted to the pediatric emergency for acute gastroenteritis (cases) and 400 children admitted to the pediatric emergency without evocative picture of infection or gastroentieritis

Description

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)

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Biological: rotavirus rapid screen test; According to routine care; Genetic: 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	Genetic: polymorphism exploration; from an oral swab collected after parents consent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-	6 months after inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
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 different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana	Six months after inclusion
Absence / presence of various HBGA polymorphisms involved in 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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Christèle GRAS-LEGUEN, MD PhD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): October 15, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 12, 2016
• First Posted (Estimate): September 15, 2016

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 8, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Vaccine; Polymorphism
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: RC15_0329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED