Genomics and COVID-19 Vaccine Adverse Events

NCT05212792 | Recruiting FDA Drug

• 1 other identifier: H21-03404
• Study Type: observational
• Target: 6,325
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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

  December 2025

Study Arms (2)

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

COVID-19 vaccines BIOLOGICAL

Any licensing COVID-19 vaccine platform

Case with COVID-19 vaccine adverse event; Control without COVID-19 vaccine adverse event

Eligibility Criteria

• Age: 5 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: collaborator
• University of British Columbia: lead

Study Sites (1)

British Columbia Children's Hospital Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

RECRUITING

Related Links

• Global Vaccine Data Network and project information

Biospecimen

Retention: SAMPLES WITH DNA

Saliva

MeSH Terms

Conditions

Guillain-Barre Syndrome; Myocarditis; Pericarditis

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Bruce Carleton, PharmD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce Carleton, PharmD

CONTACT

1.877.878.4131; bcarleton@popi.ubc.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pharmaceutical Outcomes Programme, BC Children's Hospital; Division Head, Translational Therapeutics, Department of Pediatrics, University of British Columbia

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: January 28, 2022
• Study Start: June 24, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)