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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02902445
Acronym
Gastrovimc
Enrollment
611
Registered
2016-09-15
Start date
2017-02-28
Completion date
2020-10-15
Last updated
2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastroenteritis, Gastroenteritis

Keywords

Vaccine, Polymorphism

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.

Interventions

BIOLOGICALrotavirus rapid screen test

According to routine care

GENETICpolymorphism exploration

from an oral swab collected after parents consent

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-6 months after inclusion

Secondary

MeasureTime frame
Population frequency of new protective genotypes to rotavirus infectionSix 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 GuianaSix months after inclusion
Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French GuianaSix months after inclusion
population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)Six months after inclusion

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026