Measuring the Healthy Pediatric Inflammatory Response to Vaccination.

NCT04112355 | Enrolling By Invitation

• 1 other identifier: 19-001219
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Controls

Outcome Measures

Primary Outcomes (11)

• Changes in normal pediatric interleukin-1 beta levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum interleukin-1 beta levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric interleukin-6 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum interleukin-6 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric tumor necrosis factor-alpha levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum tumor necrosis factor-alpha levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-C motif) ligand 2 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-C motif) ligand 2 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-C motif) ligand 5 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-C motif) ligand 5 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-X-C motif) ligand 1 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-X-C motif) ligand 1 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-X-C motif) ligand 2 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-X-C motif) ligand 2 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-X-C motif) ligand 8 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-X-C motif) ligand 8 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-X-C motif) ligand 9 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-X-C motif) ligand 9 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Changes in normal pediatric chemokine (C-X-C motif) ligand 10 levels in serum at 1 week after immunization relative to baseline.

  Measurement of serum chemokine (C-X-C motif) ligand 10 levels will be analyzed and compared between the pre-immunization and post-immunization timepoints. Response profiles will also be compared between subjects.

  Baseline, 1week

• Determine the range of normal single nucleotide polymorphisms in the interleukin-1 receptor antagonist (IL-1RN) gene.

  The IL-1RN gene will be sequenced from genomic DNA. Sequences will be compared between subjects and associated with cytokine and chemokine levels.

  Baseline

Study Arms (3)

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

Other: Blood Collection

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

Other: Blood Collection

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

Other: Blood Collection

Interventions

Blood Collection OTHER

Blood draw

12 months of age; 5 years of age; 6 months of age

Eligibility Criteria

• Age: 4 Months - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children scheduled for vaccinations at Mayo Clinic in Rochester, MN

You may qualify if:

• Children 5-7 months of age receiving the 3rd scheduled dose of the diphtheria, tetanus, pertussis, inactivated polio, Haemophilus influenzae type b, and pneumococcal conjugate vaccine (DTap-IPV/Hib+PCV13).
• Children 10-18 months of age receiving the 1st scheduled dose of the measles, mumps, rubella, and varicella vaccine (MMR+VZV).
• Children 4-6 years of age receiving the 2nd scheduled MMR+VZV dose.
• Children and young adults receiving the annual flu vaccine or COVID vaccine

You may not qualify if:

• History of autoinflammatory or autoimmune disease.
• History of genetic or metabolic disorder.
• History of hematological disorder.
• History of malignancy or active malignancy undergoing suppressive treatment.
• Blood donation or collection within 8 weeks of the study.
• Signs or symptoms consistent with severe infection at the time of first visit.
• Weight less than 6 kg in group 1, less than 7.5 kg for group 2, less than 12 kg for group 3.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for this study. Tests done only for research purposes are not meant to provide clinical information or help care for participants. The results are only important for research. Therefore, the results of tests will not be provided to participants. In the rare event that a finding might affect the health of a participant, the investigators will offer additional information. If the participant decides to follow up and further medical testing or care is needed, the costs will be the responsibility of the participant.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: October 2, 2019
• Study Start: August 16, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)