Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
6325 participants
OBSERVATIONAL
2022-06-24
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Case with COVID-19 vaccine adverse event
Patients with GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination
COVID-19 vaccines
Any licensing COVID-19 vaccine platform
Control without COVID-19 vaccine adverse event
Participants without experiencing GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination
COVID-19 vaccines
Any licensing COVID-19 vaccine platform
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
COVID-19 vaccines
Any licensing COVID-19 vaccine platform
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Control: Any participant who received COVID-19 vaccines and does not experience GBS, VITT/TTS, or myocarditis/pericarditis.
Exclusion Criteria
* Individuals who are unable to provide informed consent
5 Years
99 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centers for Disease Control and Prevention
FED
University of British Columbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bruce Carleton
Director, Pharmaceutical Outcomes Programme, BC Children's Hospital; Division Head, Translational Therapeutics, Department of Pediatrics, University of British Columbia
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bruce Carleton, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
British Columbia Children's Hospital Research Institute
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Bruce Carleton, PharmD
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
Global Vaccine Data Network and project information
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H21-03404
Identifier Type: -
Identifier Source: org_study_id