Clinical trial NCT03031743: The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
Official title: Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus
Keywords: rotavirus vaccine
human microbiome
fecal microbiome
vaccine immunogenicity
Rotarix
immune response, mucosal
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Wageningen University
name: University of Padova
name: Centers for Disease Control and Prevention
First posted: 2017-01-26
Enrollment: 88
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants living in a peri-urban slum outside of Karachi, Pakistan

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.


Eligibility criteria: 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

Primary outcomes:
measure: differences in fecal microbiota composition
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: Amsterdam Institute for Global Health and Development; Academic Medical Center, Amsterdam
name: Vanessa C Harris, MD
role: PRINCIPAL_INVESTIGATOR
References: