Recruiting

Genetic Factors

Sponsor:

University of British Columbia

Code:

NCT05212792

Conditions

Vaccine Adverse Reaction

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Accepted

Interventions

COVID-19 vaccines

Study Details

Brief 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).

Conditions

Vaccine Adverse Reaction

Study ID

NCT05212792

Start date

Jun 24, 2022

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 70+

Healthy Volunteers: Accepted

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:

  • Individuals who have not received a COVID-19 vaccine
  • Individuals who are unable to provide informed consent

Study Design

Enrollment

6325 participants

Anticipated

Interventions and Outcome Measures

Arms

Case with COVID-19 vaccine adverse event

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

Control without COVID-19 vaccine adverse event

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

Interventions

COVID-19 vaccines

Any licensing COVID-19 vaccine platform

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 ]

Central Contacts and Locations

Central contacts

Bruce Carleton, PharmD

1.877.878.4131bcarleton@popi.ubc.ca

Locations

British Columbia Children's Hospital Research Institute

Recruiting

Vancouver, British Columbia, Canada, V5Z 4H4

More Information

Sponsor

University of British Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Genomics
  • COVID-19 vaccine adverse event
  • Guillain-Barré syndrome (GBS)
  • Vaccine-induced Immune Thrombotic Thrombocytopenia (VITT)
  • Thrombosis with thrombocytopenia syndrome (TTS)
  • Myocarditis
  • Pericarditis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-01.