Does the Fecal Microbiome Influence Rotarix Immunogenicity

NCT02220439 | Completed

• 1 other identifier: AIGHD-CSP2013-001a
• Study Type: observational
• Target: 76
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

rotavirus; immunogenicity; enteric vaccine; vaccine immunogenicity; rotavirus vaccine; gut microbiome; microbiome

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (1)

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

  at 1 to 3 years of age post-rotavirus vaccination

Study Arms (2)

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

Eligibility Criteria

• Age: 4 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be nested within an existing rotavirus immunogenicity study being conducted in Karachi, Pakistan (clinicaltrials.gov: NCT01199874) . The physical setting is a peri-urban slum outside of Karachi, primarily populated by fishermen. Parents and legal guardians of infants participating in NCT01199874 will provide new informed consent for inclusion in this study.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Positive serum anti-rotavirus Immunoglobulin A (\> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Aga Khan University: collaborator
• Centers for Disease Control and Prevention: collaborator
• University of Padova: collaborator
• Wageningen University and Research: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

fecal samples

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Vanessa C Harris, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: V.C. Harris, M.D.

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: August 20, 2014
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 20, 2014

Record last verified: 2014-08