What this study is
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.
What's being tested
- Blood Collection
Intervention · OTHER
Blood draw
Study details
- Official title
- Establishing the Dynamic Range of Healthy Pediatric Inflammatory Responses to Vaccinations and Identifying the Role of IL1RN Polymorphisms in Controlling This Response.
- Sponsor
- Mayo Clinic
- Conditions
- Healthy Controls
- Enrolling
- 300 people
- Starts
- 2019-08-16
- Est. completion
- 2028-12
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 4 Months – 21 YearsSex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic
Rochester, Minnesota, United States
Study team
Sponsor
Mayo Clinic
Study ID 19-001219
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.