Genomics of COVID-19 Vaccine-induced Adverse Events (Guillain-Barré Syndrome [GBS], Vaccine-induced Immune Thrombotic Thrombocytopenia [VITT]/thrombosis with Thrombocytopenia Syndrome [TTS], and Myocarditis/pericarditis)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

Vaccines routinely used are extremely safe; however, severe adverse events to vaccines do occur. As vaccination against COVID-19 has begun, adverse events to the vaccine, particularly Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT)/thrombosis with thrombocytopenia syndrome (TTS), and myocarditis/pericarditis, after COVID-19 vaccination have been reported worldwide. Study hypothesis: there are genetic factors that contribute to increased risks of particular COVID-19 vaccine-induced adverse events. The objective of the study is to determine if there are specific genetic factors strongly associated with each of the COVID-19 vaccine-induced adverse events (i.e., GBS, VITT/TTS, and myocarditis/pericarditis).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 99
Healthy Volunteers: t
View:

• Case: Any patient who received COVID-19 vaccines and developed GBS, VITT/TTS, or myocarditis/pericarditis after vaccination

• Control: Any participant who received COVID-19 vaccines and does not experience GBS, VITT/TTS, or myocarditis/pericarditis.

Locations
Other Locations
Canada
British Columbia Children's Hospital Research Institute
RECRUITING
Vancouver
Contact Information
Primary
Bruce Carleton, PharmD
bcarleton@popi.ubc.ca
1.877.878.4131
Time Frame
Start Date: 2022-06-24
Estimated Completion Date: 2025-12
Participants
Target number of participants: 6325
Treatments
Case with COVID-19 vaccine adverse event
Patients with GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination
Control without COVID-19 vaccine adverse event
Participants without experiencing GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination
Sponsors
Collaborators: Centers for Disease Control and Prevention
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov