Does the Fecal Microbiome Influence Rotarix Immunogenicity

Completed

• Conditions: Rotavirus Infections; Reaction - Vaccine Nos; Intestinal Bacteria Flora Disturbance

• Registration Number: NCT02220439
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2014-06-10
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-19
• Last Update Submitted: 2014-08-19
• Study First Posted: 2014-08-20
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
microbiome diversity (Shannon's index) and composition (relative abundance)	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

Secondary Outcome Measures

Name	Time	Method
microbiome diversity (Shannon's index) and composition (relative abundance)	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