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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:
Aga Khan University
Centers for Disease Control and Prevention
University of Padua
Wageningen University and Research
Information provided by (Responsible Party):
Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

June 10, 2014
August 20, 2014
August 20, 2014
September 2013
November 2013   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
fecal samples
Non-Probability Sample
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.
  • Rotavirus Infections
  • Reaction - Vaccine Nos
  • Intestinal Bacteria Flora Disturbance
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
Same as current
November 2013
November 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02220439
AIGHD-CSP2013-001a
No
Not Provided
Not Provided
Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Aga Khan University
  • Centers for Disease Control and Prevention
  • University of Padua
  • Wageningen University and Research
Principal Investigator: Vanessa C Harris, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
August 2014