Investigating genetic factors related to COVID-19 vaccine adverse events
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)
This study is trying to find out if certain genes make some people more likely to have serious side effects from COVID-19 vaccines, like Guillain-Barré syndrome or myocarditis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6325 (estimated) |
| Ages | 5 Years to 99 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT05212792 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify genetic factors that may increase the risk of severe adverse events following COVID-19 vaccination, specifically focusing on conditions such as Guillain-Barré syndrome (GBS), vaccine-induced immune thrombotic thrombocytopenia (VITT), and myocarditis/pericarditis. The research will involve a prospective case-control design, comparing individuals who experienced these adverse events with vaccinated controls who did not. Saliva DNA samples will be collected for genomic analysis, including candidate gene studies and genome-wide association studies (GWAS), to uncover potential genetic associations. The study seeks to enhance understanding of the biological mechanisms behind these adverse events to ultimately reduce their occurrence.
Who should consider this trial
Good fit: Ideal candidates include individuals who have received COVID-19 vaccines and developed GBS, VITT/TTS, or myocarditis/pericarditis.
Not a fit: Patients who have not received a COVID-19 vaccine or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety measures and personalized approaches to COVID-19 vaccination, minimizing the risk of severe adverse events.
How similar studies have performed: While studies on vaccine adverse events exist, this specific investigation into genetic factors related to COVID-19 vaccine adverse events is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Individuals who have not received a COVID-19 vaccine * Individuals who are unable to provide informed consent
Where this trial is running
Vancouver, British Columbia
- British Columbia Children's Hospital Research Institute — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Bruce Carleton, PharmD — University of British Columbia
- Study coordinator: Bruce Carleton, PharmD
- Email: bcarleton@popi.ubc.ca
- Phone: 1.877.878.4131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.