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The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan

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ClinicalTrials.gov Identifier: NCT03031743
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
Aga Khan University
Wageningen University
University of Padova
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary:
This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in 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

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Study Type : Observational
Actual Enrollment : 88 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 : January 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : July 2015

Group/Cohort
rotavirus (Rotarix TM) vaccination
Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874)



Primary Outcome Measures :
  1. differences in fecal microbiota composition [ Time Frame: 2 years ]
    The primary study objective is to see if there are significant differences in the fecal microbiota composition between rotavirus vaccine (Rotarix TM) immune responders (defined as anti-RV IgA antibodies at a concentration of > or = to 20 U/ml in a previously seronegative individual 4 weeks after the last Rotarix dose) and rotavirus vaccine immune non-responders (defined as anti-RV IgA antibodies at a concentration of <20 U/mL 4 weeks after the last Rotarix dose)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants living in a peri-urban slum outside of Karachi, Pakistan
Criteria

Inclusion Criteria:

  • Infants already consented and enrolled in the overarching study: Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity or Rotarix Vaccine trial (NCT01199874)

Overarching study (NCT01199874)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
  • written informed consent obtained from parents or guardians for overarching study Nested study additional inclusion criteria
  • written informed consent obtained from parents or legal guardians for this nested study
  • availability of a baseline, pre-vaccination fecal sample

Exclusion Criteria:

Overarching study (NCT01199874)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 trials
  • birth weight less than 1500 grams; or if birthweight 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 IgA (> or= 20U/mL) at 6 weeks of age, indicative of rotavirus infection prior to vaccination

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): NCT03031743


Locations
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Pakistan
Aga Khan University
Karachi, Pakistan, 74800
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Aga Khan University
Wageningen University
University of Padova
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Vanessa C Harris, MD Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam
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Responsible Party: Vanessa Harris, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03031743    
Other Study ID Numbers: AIGHD-CSP2013-001
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Keywords provided by Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
rotavirus vaccine
human microbiome
fecal microbiome
vaccine immunogenicity
Rotarix
immune response, mucosal