Measuring the Healthy Pediatric Inflammatory Response to Vaccination.

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04112355
Status
Enrolling By Invitation

Conditions

  • Healthy Controls

Eligibility Criteria

Sex
ALL
Age
4 Months - 21 Years
Healthy Volunteers
Accepted

Interventions

  • Blood Collection — OTHER
    Blood draw

Study Details

The purpose of this research is to understand the normal healthy response to immunological challenge by measuring circulating cytokine and chemokine levels before and after vaccinations in healthy children. These data will define a range of normal responses that can be used to help us understand pathogenic mechanisms in children who do not respond normally to infections. In addition, this study will test the hypothesis that genetic polymorphisms in the interleukin-1 receptor antagonist gene are associated with differential inflammatory responses across the healthy spectrum.

Key Dates

Start date
Aug 16, 2019
Status verified
Jan 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 6 months of age
    Visit 1 This visit will take about 15 minutes and will be at the time of the next scheduled clinical vaccinations. Study procedures at this visit include : * Draw a blood sample based on age groups below * Provided a temperature diary to fill out for the next week Visit 2 This visit will take about 15 minutes and will be approximately 7 days after the first visit. Study procedures at this visit include : * Draw a blood sample based on age groups below * Collect temperature diary if not already mailed in
  • Arm: 12 months of age
    Visit 1 This visit will take about 15 minutes and will be at the time of the next scheduled clinical vaccinations. Study procedures at this visit include : * Draw a blood sample based on age groups below * Provide a temperature diary to fill out for the next week Visit 2 This visit will take about 15 minutes and will be approximately 7 days after the first visit. Study procedures at this visit include : * Draw a blood sample based on age groups below * Collect temperature diary if not already mailed in
  • Arm: 5 years of age
    Visit 1 This visit will take about 15 minutes and will be at the time of the next scheduled clinical vaccinations. Study procedures at this visit include : * Draw a blood sample based on age groups below * Provide a temperature diary to fill out for the next week Visit 2 This visit will take about 15 minutes and will be approximately 7 days after the first visit. Study procedures at this visit include : * Draw a blood sample based on age groups below * Collect temperature diary if not already mailed in

Primary Outcome Measure

Changes in normal pediatric interleukin-1 beta levels in serum at 1 week after immunization relative to baseline. [ Time Frame: Baseline, 1week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905-

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