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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Acute Gastroenteritis; Gastroenteritis

Treatments: Biological: rotavirus rapid screen test; Genetic: polymorphism exploration

Study type: Observational

Funder types: Other

Identifiers

NCT02902445

RC15_0329

Details and patient eligibility

About

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.

Full 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.

Enrollment: 611 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

611 participants in 2 patient groups

Case group

Description:

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

Treatment:

Genetic: polymorphism exploration

Biological: rotavirus rapid screen test

Control group

Description:

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

Treatment:

Genetic: polymorphism exploration