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Completed

NCT Number: NCT03031743

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.

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Key information

Conditions

Rotavirus

Age range

6 week–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aga Khan University

Karachi, 74800, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 26, 2017
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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