Vaccine Adverse ReactionNCT05212792
Genomics and COVID-19 Vaccine Adverse Events
An observational study of Vaccine Adverse Reaction, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 5 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Adverse Reaction
- What is being tested?
- COVID-19 vaccines
- Type of treatment
- Vaccines
- How many people
- 6,325 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2022to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- Individuals who have not received a COVID-19 vaccine
- Individuals who are unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital Research Institute
Vancouver, British Columbia, V5Z 4H4
Bruce Carleton, PharmD
About this study
Official title: 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)
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).
Read the 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.
- Conditions
- Vaccine Adverse Reaction
- Being tested
- COVID-19 vaccines
- Keywords
- Genomics, COVID-19 vaccine adverse event, Guillain-Barré syndrome (GBS), Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), Thrombosis with thrombocytopenia syndrome (TTS), Myocarditis, Pericarditis
- Medical subject headings
- Guillain-Barre Syndrome, Myocarditis, Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccinesBiological
Any licensing COVID-19 vaccine platform
| Study group | Role | What they receive |
|---|---|---|
| Case with COVID-19 vaccine adverse event | Patients with GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination Receives: Biological: COVID-19 vaccines | |
| Control without COVID-19 vaccine adverse event | Participants without experiencing GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination Receives: Biological: COVID-19 vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start24 Jun 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine Adverse ReactionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6,325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Bruce Carleton, University of British Columbia
- Investigators
- Bruce Carleton, PharmD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212792
- Sponsor's protocol ID
- H21-03404
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2022
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05212792
- Acronym / sponsor ID
- H21-03404
- Conditions
- Vaccine Adverse Reaction
- Keywords
- Genomics, COVID-19 vaccine adverse event, Guillain-Barré syndrome (GBS), Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT), Thrombosis with thrombocytopenia syndrome (TTS), Myocarditis, Pericarditis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,325 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case with COVID-19 vaccine adverse event | – | Biological: COVID-19 vaccinesPatients with GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination |
| Control without COVID-19 vaccine adverse event | – | Biological: COVID-19 vaccinesParticipants without experiencing GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Individuals who have not received a COVID-19 vaccine
- Individuals who are unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccinesAny licensing COVID-19 vaccine platform | Biological | Case with COVID-19 vaccine adverse event, Control without COVID-19 vaccine adverse event |
Primary outcome
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 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Global Vaccine Data Network and project informationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruce Carleton, PharmD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Adverse Reaction, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruce Carleton, PharmD (1.877.878.4131, bcarleton@popi.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.