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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 611
- 试验地点
- 1
- 主要终点
- Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Absence / Presence of non-secretory polymorphisms FUT2- and Lewis Negative FUT3-
时间窗: 6 months after inclusion
次要结局
- Population frequency of new protective genotypes to rotavirus infection(Six months after inclusion)
- Absence / presence of genetic polymorphisms --other (Including FUT2- and FUT3-)(Six months after inclusion)
- Absence / presence of various HBGA polymorphisms involved in acute gastroenteritis episodes in French Guiana(Six months after inclusion)
- Absence / presence of different viral strains Rotavirus (RVA) involved in the acute gastroenteritis episodes in French Guiana(Six months after inclusion)
- population frequency of different etiologies of acute gastroenteritis viral, bacterial and / or parasitic (Cayenne)(Six months after inclusion)