Genomics and COVID-19 Vaccine Adverse Events
ConditionVaccine Adverse Reaction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-99
SponsorUniversity of British Columbia
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Individuals who have not received a COVID-19 vaccine
Individuals who are unable to provide informed consent
Trial population
Any individual who received a COVID-19 vaccine. A total of 825 adverse event cases (n=275 each for GBS, VITT/TTS, and myocarditis/pericarditis) and 5,500 vaccine-matched controls (n=2,750 each for mRNA and adenovirus vector COVID-19 vaccine platforms) will be recruited.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
COVID-19 vaccines
Biological/VaccineAny licensing COVID-19 vaccine platform
Treatment groups
6,325 Participants
are divided into 2 treatment groupsGroup A: Case with COVID-19 vaccine adverse event1 intervention
Group B: Control without COVID-19 vaccine adverse event1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
December 2025Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Centers for Disease Control and Prevention
Collaborator
Source ClinicalTrials.gov