An Open Single-arm Interventional Study to Identify the Influence of Human Genetic Variation on Early Transcriptional Responses and Protective Immunity Following Immunization With Rotarix Rotavirus Vaccine in Infants in HCM City in Vietnam
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 818
- 试验地点
- 2
- 主要终点
- The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.
研究概览
简要总结
The primary objective is to measure the effect of host human genetics on the resulting immunological responses and long-term protection following rotavirus immunization of a study population of infants in Ho Chi Minh City, Vietnam.
The secondary objectives are to assess the temporal immunological responses following rotavirus vaccination, and to investigate the role of maternally derived antibodies, and other factors that could potentially affect immunological responses following rotavirus vaccination. Also to assess infecting rotavirus genotypes in the vaccine failure cases.
详细描述
This study will be an open single arm, single centre, interventional study conducted in Ho Chi Minh City, Vietnam. A sample size of 1,000 infants will be recruited to the study between 8 to 9 weeks (which is around 2 months) of age. These infants will receive two doses of the rotavirus vaccine, Rotarix with an interval of 28-37 days (or 4-5 weeks). The parents will be requested to bring the infants 2-3 days following each Rotarix vaccination to receive the standard EPI vaccinations. The infants will then be under passive and active surveillance for rotavirus-associated diarrhoea until 18 months of age. Blood samplings during pre and post vaccination and at 6, 12 and 18 month old visits will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Weeks 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants (both males and females) between 8 and 9 weeks (i.e. approximately 2 months) of age who are attending Hung Vuong Hospital to receive their standard EPI vaccinations.
- •Currently registered residents of Districts 5 (where Hung Vuong Hospital is located) or 1, 6, 8, 10, or 11 (districts that are neighbouring district 5) in Ho Chi Minh city, with no specific intention of relocating in the next 12 months.
- •Informed consent to be enrolled in the study and comply with study procedures, including host genetic studies.
排除标准
- •Refusal of consent.
- •Parent/ guardian under the age of
- •Premature (i.e. gestation period <37 weeks).
- •Infants who have already been immunized with either a rotavirus vaccine or the standard 2-month EPI vaccinations.
- •History of hypersensitivity to any components of the vaccine or adverse vaccine event.
- •History of intussusception or congenital malformation of the gastrointestinal tract in the child that is likely to predispose child to intussusception.
- •History of severe combined immunodeficiency disease (SCID), acquired immune deficiency syndrome (AIDS) or Human immunodeficiency virus (HIV) positivity, or other known immunodeficiency syndromes that may place the child at risk during immunisation.
结局指标
主要结局
The rotavirus vaccine failure events during the time period from recruitment to 18 months of age.
时间窗: from the recruitment to 18 months of age after the first dose of vaccination
The primary endpoint is to measure the proportion of rotavirus vaccine failure events during the time period from recruitment to 18 months of age after the first dose of vaccination.
次要结局
- Quantification of the antibody response following immunization(data collected during 7 site visits (Visit 1: Rotarix Dose 1, Visit 2: 2-3 after Visit 1, Visit 3: 28-37 days after Visit 1, Visit 4: 2-3 days after Visit 3, Visit 5: 6 months old, Visit 6: 12 months old, Visit 7: 18 months old))
- Assessment of infecting rotavirus genotypes in vaccine failure cases(from the recruitment to 18 months of age after the first dose of vaccination)