Trials / Completed
CompletedNCT02902445
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 611 (actual)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rotavirus rapid screen test | According to routine care |
| GENETIC | polymorphism exploration | from an oral swab collected after parents consent |
Timeline
- Start date
- 2017-02-28
- Primary completion
- 2020-10-15
- Completion
- 2020-10-15
- First posted
- 2016-09-15
- Last updated
- 2022-04-11
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT02902445. Inclusion in this directory is not an endorsement.