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

January 23, 2017 updated by: Vanessa Harris, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Infants living in a peri-urban slum outside of Karachi, Pakistan

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of Padova
Centers for Disease Control and Prevention
Aga Khan University
Wageningen University

Investigators

  • Principal Investigator: Vanessa C Harris, MD, Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

July 12, 2016

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 26, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AIGHD-CSP2013-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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