Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 1
- 主要终点
- Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
研究概览
简要总结
Oral polio and rotavirus vaccines are significantly less effective in children living in the developing world. Tropical enteropathy, which is associated with intestinal inflammation, decreased absorption and increased permeability, may contribute substantially to oral vaccine failure in developing country settings. Other possible causes of oral vaccine underperformance include malnutrition, interference with maternal or breast milk antibodies, changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus vaccines is associated with the presence of tropical enteropathy.
详细描述
Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine to the child with two group; with inactivated poliovirus vaccine and without inactivated poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 42 Days 至 49 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother willing to sign informed consent form.
- •Infant aged 0 to 49 days old.
- •No obvious congenital abnormalities or birth defects.
排除标准
- •Parents are not willing to have child's blood drawn.
- •Parents are planning to enroll child into another clinical study during the time period of this trial.
- •Mother not willing to have blood drawn and breast milk extracted.
- •Parents not willing to have field research assistant in home.
- •History of seizures or other apparent neurologic disorders.
- •Infant does not have proof of BCG and OPV since birth by immunization card.
- •History of acute illness and/or immunocompromised state of the child.
- •Immunocompromised or chronically ill mother
研究组 & 干预措施
IPV vaccination
Randomized IPV vaccination to children at the age of 39 weeks.
干预措施: IPV vaccination (Biological)
OPV vaccination
Randomized OPV vaccination to children at the age of 39 weeks.
干预措施: IPV vaccination (Biological)
结局指标
主要结局
Vaccine immunogenicity of oral vaccines (Oral Polio Vaccine and Rotavirus Vaccine) with the presence of tropical enteropathy using Lactose/Mannitol ratio in urine.
时间窗: Birth to one year
Responsiveness of oral vaccines compare with Tropical Enteropathy and without Tropical Enteropathy; using lactose/mannitol ratio.
次要结局
- Mucosal immune responses (shedding OPV vaccine virus) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).(Birth to one year)
- Systemic immune responses (neutralizing antibodies) of impact of an inactivated polio vaccine (IPV) and polio vaccine boost following vaccination with oral polio vaccine (OPV).(Birth to one year)