Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in Bangladesh
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial)
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 breastmilk antibodies, changes in gut microbiota, and genetic susceptibility.
Primary Objective: to determine whether tropical enteropathy impairs the efficacy of oral polio and rotavirus vaccines in children in Bangladesh.
Secondary Objectives: 1) to determine the impact of an IPV (inactivated polio vaccine) boost on the efficacy of OPV (oral polio vaccine) and 2) to determine the efficacy of Rotarix oral rotavirus vaccine to prevent rotavirus diarrhea
The polio and rotavirus randomized clinical trials are embedded as secondary objectives within the exploratory study of tropical enteropathy. The primary and secondary outcome measures are relevant to the randomized clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mother willing to sign informed consent form.
- •Healthy infant aged 0 to 7 days old.
- •No obvious congenital abnormalities or birth defects.
- •No abnormal (frequency and consistency) stools since birth.
- •Stable household with no plans to leave the area for the next one year.
排除标准
- •Parents are not willing to have child vaccinated at the field clinic.
- •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 two times per week.
- •History of seizures or other apparent neurologic disorders.
- •Infant received any vaccines before start of study, except Bacillus Calmette-Guerin (BCG).
- •Infant has any sibling currently or previously enrolled in this study, including a twin.
研究组 & 干预措施
Rotarix + No IPV (inactivated polio vaccine)
Oral Rotarix vaccine at 10 and 17 weeks of age and oral polio vaccine series
干预措施: Rotarix (Biological)
Rotarix + IPV (inactivated polio vaccine)
Oral Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks
干预措施: IPV (inactivated polio vaccine) (Biological)
Rotarix + IPV (inactivated polio vaccine)
Oral Rotarix vaccine at 10 and 17 weeks of age plus IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks
干预措施: Rotarix (Biological)
No Rotarix + IPV (inactivated polio vaccine)
No Rotarix vaccine and IPV (inactivated polio vaccine) boost in place of oral polio vaccine dose at 39 weeks
干预措施: IPV (inactivated polio vaccine) (Biological)
结局指标
主要结局
Presence of Fecal Shedding of Polio Vaccine Virus Determined by Culture (Polio Trial)
时间窗: 25 days following week 52 visit
Any Sabin type poliovirus in any fecal samples at days 0, 4, 11, 18 or 25 following week 52 dose
Number of Participants With One or More Episodes of Rotavirus-associated Diarrhea (Rotavirus Trial)
时间窗: Birth to one year
Diarrheal episode defined as presence of 3 or more abnormally loose stools in 24h period with \>=72 hours separating episodes. Rotavirus antigen detected by ELISA in diarrheal stool.
次要结局
- Total Number of Diarrheal Episodes (Rotavirus Trial)(Birth to one year)
- Total Duration of Rotavirus-associated Diarrheal Episodes (Rotavirus Trial)(Birth to one year)
- Duration of Fecal Shedding of Polio Vaccine Virus, Each Sabin Type (Polio Trial)(from day 4 to day 25 following the week 52 visit)
- Community Fecal Shedding of Polio Vaccine Virus Just Prior to Oral Polio Vaccine Dose at 52 Weeks (Polio Trial)(post 52 weeks)
- Presence of Fecal Polio Virus Shedding Within the Three Sabin Strains (Polio Trial)(25 days following week 52 visit)
- Serum Neutralizing Antibody Response (Polio Trial)(18-40 weeks)
研究者
Beth Kirkpatrick
M.D.
University of Vermont