Does the Fecal Microbiome Influence Rotarix Immunogenicity
Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
研究概览
研究类型
注册 (实际的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
- Availability of baseline fecal sample collected before Rotarix vaccination
- Written informed consent obtained from the parents or guardians for nested study
Exclusion Criteria:
- Hypersensitivity to any of the vaccine components
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusceptions or abdominal surgery.
- Enrollment in any other trial (besides NCT01199874).
- Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
- Immunoglobulin and/or blood products use since birth or during the study period. Nested study additional exclusion criteria:
- Positive serum anti-rotavirus Immunoglobulin A (> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection
学习计划
研究是如何设计的？
设计细节
- 观测模型：病例对照
- 时间观点：预期
队列和干预
团体/队列 |
|---|
|
Case: non-rotavirus seroconverters
Infants not demonstrating seroconversion to rotavirus vaccination, as measured anti-RV Immunoglobulin A < 20 U/ml
|
|
Control: rotavirus seroconverters
Infants demonstrating seroconversion to rotavirus vaccination, as measured by anti-rotavirus Immunoglobulin A > 20 U/ml
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
microbiome diversity (Shannon's index) and composition (relative abundance)
大体时间：at 6 weeks of age, pre-rotavirus vaccination
|
Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups |
at 6 weeks of age, pre-rotavirus vaccination
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
microbiome diversity (Shannon's index) and composition (relative abundance)
大体时间：at 1 to 3 years of age post-rotavirus vaccination
|
Microbiota composition post vaccination will be measured by calculating and comparing a % of the phylogenetic groups present in both groups Diversity post vaccination will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups The relative abundance of microbial groups post vaccination will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups |
at 1 to 3 years of age post-rotavirus vaccination
|
合作者和调查者
合作者
调查人员
- 首席研究员：Vanessa C Harris, MD、Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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