Additional Information
The COBRA study (A randomized, double-blind, placebo-controlled phase 3 study: Efficacy and safety of the recombinant VPM1002 BCG vaccine in reducing SARS-CoV-2 infection rate and COVID-19 severity) is examining if a novel version of the common vaccine called Bacille Calmette Guerin (BCG) can reduce the incidence and severity of COVID-19. BCG vaccine is already used globally for prevention of tuberculosis. Recent studies suggest that the BCG vaccine could also improve the body’s immune system and provide protection against other viral infections. This study involves an investigational version of the BCG vaccine called VPM1002.
Our team at UHN is conducting this study to determine the effectiveness of the VPM1002 vaccine to reduce the rate of occurrence and disease severity of COVID-19 infection. In this study, half of the participants received the VPM1002 vaccine and the other half received a placebo (substance that looks like the vaccine with no active ingredients). Blood samples (approximately 1 tablespoon) were collected before vaccination and at the end of the study (7 months later). Participants were asked to complete a short online follow-up questionnaire regarding COVID-19 status and changes in health every 2 weeks.
All information collected in this study will remain confidential. No information will be shared with your employer.
Participation is always voluntary.
Key Eligibility Criteria
- No prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination
- Adequate immune system function: no congenital dysfunction or immunosuppression caused by disease, drugs or other therapy
- No known kidney, liver, or blood disorders which impairs organ and marrow function
- No current use of steroids (>10 mg prednisone equivalent/day)
- Not pregnant or planning to become pregnant in the subsequent 7 months
- Not breastfeeding
- Not participating in another interventional drug study in the past 30 days
- No previous positive COVID-19 infection test