Clinical trial NCT02902445: Glycan Attachment Specificity, Toward ROtavirus Vaccine IMprovement GASTROVIMc (Clinical Investigation)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Acute Gastroenteritis
Keywords: Vaccine
Polymorphism
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 611
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-
timeFrame: 6 months after inclusion
Secondary outcomes:
measure: Population frequency of new protective genotypes to rotavirus infection
timeFrame: Six months after inclusion
measure: Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)
timeFrame: Six months after inclusion
measure: Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana
timeFrame: Six months after inclusion
measure: Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana
timeFrame: Six months after inclusion
measure: population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)
timeFrame: Six months after inclusion
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Christèle GRAS-LEGUEN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: