NCT05212792

Genomics and COVID-19 Vaccine Adverse Events

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 6,325 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 5 Years – 99 Years
• Healthy volunteers: Accepted

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).

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

Interventions

Type	Name	Description
BIOLOGICAL	COVID-19 vaccines	Any licensing COVID-19 vaccine platform

Timeline

• Start date: 2022-06-24
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-01-28
• Last updated: 2024-12-05

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study