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Does the Fecal Microbiome Influence Rotarix Immunogenicity

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ClinicalTrials.gov Identifier: NCT02220439
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Rotavirus Infections Reaction - Vaccine Nos Intestinal Bacteria Flora Disturbance

Study Design

Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
Study Start Date : September 2013
Primary Completion Date : November 2013
Study Completion Date : November 2013
Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



Biospecimen Retention:   Samples Without DNA
fecal samples

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220439


Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aga Khan University
Centers for Disease Control and Prevention
University of Padua
Wageningen University and Research Centre
Investigators
Principal Investigator: Vanessa C Harris, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
More Information

Responsible Party: Vanessa Harris, V.C. Harris, M.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02220439     History of Changes
Other Study ID Numbers: AIGHD-CSP2013-001a
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
rotavirus
immunogenicity
enteric vaccine
vaccine immunogenicity
rotavirus vaccine
gut microbiome
microbiome

Additional relevant MeSH terms:
Rotavirus Infections
Dysbiosis
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Pathologic Processes
Vaccines
Immunoglobulin A
Immunologic Factors
Physiological Effects of Drugs