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Completed

NCT Number: NCT02902445

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

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.

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Key information

Conditions

Gastroenteritis Acute Gastroenteritis Digestive System Diseases Gastrointestinal Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rotavirus rapid screen test

Biological

According to routine care

polymorphism exploration

Genetic

from an oral swab collected after parents consent

Primary outcomes

  1. Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-

    Time frame: 6 months after inclusion

Secondary outcomes

  1. Population frequency of new protective genotypes to rotavirus infection

    Time frame: Six months after inclusion

  2. Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)

    Time frame: Six months after inclusion

  3. Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana

    Time frame: Six months after inclusion

  4. Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana

    Time frame: Six months after inclusion

  5. population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)

    Time frame: Six months after inclusion

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: Gastrovimc

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 15, 2016
Registry last updated
Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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