Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05212792 |
| Other study ID # |
H21-03404 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 24, 2022 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
November 2023 |
| Source |
University of British Columbia |
| Contact |
Bruce Carleton, PharmD |
| Phone |
1.877.878.4131 |
| Email |
bcarleton[@]popi.ubc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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.
