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

NCT03031743 | Completed

• 1 other identifier: AIGHD-CSP2013-001
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotavirus

Keywords

rotavirus vaccine; human microbiome; fecal microbiome; vaccine immunogenicity; Rotarix; immune response, mucosal

Outcome Measures

Primary Outcomes (1)

• differences in fecal microbiota composition

  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

Study Arms (1)

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)

Eligibility Criteria

• Age: 6 Weeks - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)
• 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 legal guardians for this nested study
• availability of a baseline, pre-vaccination fecal sample

You may not qualify if:

• 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
• positive serum anti-rotavirus IgA (\> or= 20U/mL) at 6 weeks of age, indicative of rotavirus infection prior to vaccination

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Aga Khan University: collaborator
• Wageningen University: collaborator
• University of Padova: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Aga Khan University

Karachi, 74800, Pakistan

Location

Study Officials

• Vanessa C Harris, MD

  Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: January 26, 2017
• Study Start: January 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

PA (1)