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

Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031743
• Other study ID #: AIGHD-CSP2013-001
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: January 23, 2017
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotavirus

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi

Sponsors (5)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Aga Khan University, Centers for Disease Control and Prevention, University of Padova, Wageningen University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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