ClinicalTrials.gg
RecruitingNCT05212792Updated May 1, 2026

Genomics and COVID-19 Vaccine Adverse Events

An observational study in Vaccine Adverse Reaction, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 5 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of British Columbia · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
6,325
Ages
5 Years to 99 Years
Sex
All
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Study 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).

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.
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Conditions studied

  • 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
03

In context

Guillain-Barre Syndrome

96 studies on the registry are indexed under Guillain-Barre Syndrome; 28 are open to participants now.

This study's planned enrollment of 6,325 is above the median of 100 across 47 observational studies indexed under Guillain-Barre Syndrome.

Browse Guillain-Barre Syndrome studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Individuals who have not received a COVID-19 vaccine
  • Individuals who are unable to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
6,325 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Case with COVID-19 vaccine adverse event

    Patients with GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination

    Biological: COVID-19 vaccines

  • Control without COVID-19 vaccine adverse event

    Participants without experiencing GBS, VITT/TTS, or myocarditis/pericarditis after COVID-19 vaccination

    Biological: COVID-19 vaccines

Interventions

  • BiologicalCOVID-19 vaccines

    Any licensing COVID-19 vaccine platform

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What researchers measure

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 2025

07

Study locations

1 of 1 sites recruiting
  • British Columbia Children's Hospital Research Institute
    Vancouver, British Columbia V5Z 4H4, Canada
    Recruiting
    • Bruce Carleton, PharmD · Contact
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References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2022 (actual). Primary completion is estimated for Dec 2026, 54 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 25, 2022
First posted
Jan 28, 2022
StartActual
Jun 24, 2022
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
May 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05212792
Responsible party
Bruce Carleton (Director, Pharmaceutical Outcomes Programme, BC Children's Hospital; Division Head, Translational Therapeutics, Department of Pediatrics, University of British Columbia, University of British Columbia) — Principal investigator
First posted
Jan 28, 2022
Start date
Jun 24, 2022
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 1, 2026

Study contacts

Bruce Carleton, PharmD
Contact
bcarleton@popi.ubc.ca
1.877.878.4131
Bruce Carleton, PharmD
principal investigator · University of British Columbia

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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