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

Gastroenteritis Clinical Trial

— Gastrovimc  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02902445
• Other study ID #: RC15_0329
• Status: Completed
• Start date: February 28, 2017
• Est. completion date: October 15, 2020

Study information

• Verified date: April 2021
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: October 15, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

Biological:
• rotavirus rapid screen test
According to routine care

Genetic:
• polymorphism exploration
from an oral swab collected after parents consent

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-		6 months after inclusion
Secondary	Population frequency of new protective genotypes to rotavirus infection		Six months after inclusion
Secondary	Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)		Six months after inclusion
Secondary	Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana		Six months after inclusion
Secondary	Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana		Six months after inclusion
Secondary	population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)		Six months after inclusion