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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03031743

Enrollment

Registered

2017-01-26

Start date

2014-01-31

Completion date

2015-07-31

Last updated

2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotavirus

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 3 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
differences in fecal microbiota composition	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)

Countries

Pakistan

Outcome results