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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02220439

Enrollment

Registered

2014-08-20

Start date

2013-09-30

Completion date

2013-11-30

Last updated

2014-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Bacteria Flora Disturbance, Reaction - Vaccine Nos, Rotavirus Infections

Keywords

rotavirus, immunogenicity, enteric vaccine, vaccine immunogenicity, rotavirus vaccine, gut microbiome, microbiome

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Weeks to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results