A Study to Evaluate the Spectrum of Healthy Pediatric Inflammatory Responses to Vaccinations

Overview

About this study

The purpose of this study is to understand the role of systemic inflammation in the genesis of seizures in susceptible children by gaining a clearer understanding of the spectrum of inflammatory responses that occur in healthy children post-vaccinations.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Group 1: children 5-7 months of age receiving the 3rd scheduled DTap-IPV/Hib+PCV13 dose.
  • Group 2: children 10-18 months of age receiving the 1st scheduled MMR+VZV dose.
  • Group 3: children 4-6 years of age receiving the 2nd scheduled MMR+VZV dose.
  • Group 4: children 0-12 years of age receiving the influenza vaccine or nasal mist.
  • Group 5: children 0-12 years of age receiving the SARS-CoV-2 vaccine.
  • Group 6: children in any of the above groups that were scheduled for a clinical vaccination after their first research blood collection, but it was cancelled by the provider for any reason.
  • Group 7: young adults 18-21 years of age receiving the influenza vaccine or nasal mist or SARS-CoV-2 vaccine.

Exclusion Criteria:

  • 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 and less than 6 kg for groups 4 & 5.
  • Additional vaccination within 3 weeks prior to baseline blood draw.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Charles Howe, Ph.D.

Open for enrollment

Contact information:

Center for Multiple Sclerosis and Autoimmune Neurology

DLCMSANResCoor@mayo.edu

More information

Publications

Publications are currently not available