Genomics and COVID-19 Vaccine Adverse Events
- Conditions
- Vaccine Adverse Reaction
- Interventions
- Biological: COVID-19 vaccines
- Registration Number
- NCT05212792
- Lead Sponsor
- University of British Columbia
- Brief 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).
- Detailed Description
Purpose:
Reduce the risk of COVID-19 vaccine-induced adverse events (i.e., GBS, VITT/TTS, and myocarditis/pericarditis) through improved understanding of the biology underlying these severe adverse events and the genetic contribution to their cause
Research Design:
* Prospective case-control study designs will be performed to investigate the genetic associations of Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT)/thrombosis with thrombocytopenia syndrome (TTS), and myocarditis/pericarditis strongly associated (OR ≥ 3.0) with COVID-19 vaccination.
* Determined cases of specific COVID-19 vaccine-induced GBS, VITT/TTS, and myocarditis/pericarditis, and vaccinated controls without these adverse events will be included.
* Saliva DNA samples from eligible adverse event cases and vaccinated controls will be collected.
* Candidate gene and genome-wide association studies (GWAS) approaches will be conducted.
* Genomics analyses will be stratified by severity, age, sex, vaccine, and other critical covariates as determined by the GVDN Work Group for each adverse event and as adequately powered analyses allow.
* To complement GWAS, particularly in protein-coding regions, additional whole-exome sequencing (WES) will be performed on the most severe patients who are categorized as Brighton Collaboration Level One case of COVID-19 vaccine-induced adverse events to identify the most possible disease-causing mutations.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6325
- 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.
- Individuals who have not received a COVID-19 vaccine
- Individuals who are unable to provide informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case with COVID-19 vaccine adverse event COVID-19 vaccines Patients with GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination Control without COVID-19 vaccine adverse event COVID-19 vaccines Participants without experiencing GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination
- Primary Outcome Measures
Name Time Method Determine specific genetic factors associated with particular COVID-19 vaccine-induced Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT)/thrombosis with thrombocytopenia syndrome (TTS), and myocarditis/pericarditis December 2025
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
British Columbia Children's Hospital Research Institute
🇨🇦Vancouver, British Columbia, Canada