Does the Fecal Microbiome Influence Rotarix Immunogenicity

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.

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Key information

Conditions

Rotavirus Infections Infections Intestinal Bacteria Flora Disturbance RNA Virus Infections Reaction - Vaccine Nos Reoviridae Infections Virus Diseases

Age range

4 week and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 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 outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

Aga Khan University
Centers for Disease Control and Prevention
University of Padova
Wageningen University and Research

Registry information

Official study title

Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Aug 20, 2014
Registry last updated: Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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