Does the Fecal Microbiome Influence Rotarix Immunogenicity

Rotavirus Infections 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: NCT02220439
• Other study ID #: AIGHD-CSP2013-001a
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: August 19, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

This is a proposal for a nested case‐control study within an ongoing rotavirus vaccine immunogenicity clinical trial 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: 76
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 into in the study.

• Written informed consent obtained from the parents or guardians.

• Availability of baseline fecal sample collected before Rotarix vaccination

• Written informed consent obtained from the parents or guardians for nested study

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 trial (besides NCT01199874).

• Birth weight less than 1500 grams; or if birth weight 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 Immunoglobulin A (> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dysbiosis
• Intestinal Bacteria Flora Disturbance
• Reaction - Vaccine Nos
• Rotavirus Infections

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microbiome diversity (Shannon's index) and composition (relative abundance)	Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups; Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups; The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups	at 6 weeks of age, pre-rotavirus vaccination	No
Secondary	microbiome diversity (Shannon's index) and composition (relative abundance)	Microbiota composition post vaccination will be measured by calculating and comparing a % of the phylogenetic groups present in both groups; Diversity post vaccination will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups; The relative abundance of microbial groups post vaccination will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups	at 1 to 3 years of age post-rotavirus vaccination	No