Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity (COBRA)
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|ClinicalTrials.gov Identifier: NCT04439045|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
Bacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness.
Front-line police officers are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees of the police forces in Ontario.
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2 Infection||Biological: VPM1002 Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3626 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Masking Description:||The clinical trial is designed as a double-blind (observer blind) study. Observer-blind means that during the course of trial, the companions/parents/guardians of the subjects and the study personnel responsible for the evaluation of any study endpoint will be unaware which vaccine was administered.|
|Official Title:||A Randomized, Double-blind, Placebo-controlled Phase 3 Study: Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 Infection Rate and COVID-19 Severity|
|Estimated Study Start Date :||June 14, 2020|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||June 1, 2021|
A single dose of 0.1 mL of the reconstituted vaccine containing VPM1002 (Mycobacterium bovis rBCGΔureC::hly, live 2-8 × 105 CFU), administered via intradermal injection.
VPM1002 is a recombinant BCG (rBCG)
Other Name: Mycobacterium bovis rBCGΔureC::hly
Placebo Comparator: Placebo
A single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection.
0.9% sodium chloride
Other Name: sodium chloride
- COVID-19 infection [ Time Frame: 7 months ]To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.
- Incidence of hospitalization for COVID-19 [ Time Frame: 7 months ]To compare the incidence of hospitalization in participants with self-reported positive COVID-19 test, subsequently confirmed by review of medical records.
- Incidence of ICU admission for COVID-19 [ Time Frame: 7 months ]To compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with self-reported positive COVID-19 test, subsequently confirmed by review of medical records.
- Incidence of ARDS [ Time Frame: 7 months ]Incidence of acute respiratory distress syndrome (ARDS) in participants with positive COVID-19 test treated with either VPM1002 or placebo.
- Mechanical ventilation for COVID-19 [ Time Frame: 7 months ]Compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo. Confirmed by review of medical records
- Secondary infection in COVID-19 [ Time Frame: 7 months ]To compare the incidence of secondary infection in participants with positive COVID-19 test treated with either VPM1002 or placebo.
- COVID-19-related Mortality [ Time Frame: 7 months ]To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo.
- Innate Trained Immunity [ Time Frame: 7 months ]To evaluate the ability of the VPM1002 vaccine to prime an innate trained immunity (i.e. inducing Th1 and Th17 responses to unrelated stimuli) compared to participants administered placebo.
- Incidence of COVID-19 in Participants with Past BCG Vaccination [ Time Frame: 7 months ]Compare the incidence of COVID-19 in participants who have received BCG vaccination previously.
- Measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin as biomarkers of COVID-19 [ Time Frame: 7 months ]To measure cardiac troponin, B-type natriuretic peptide, N-terminal pro b-type natriuretic peptide, C reactive protein, serum amyloid A, and procalcitonin identified as potential biomarkers of COVID-19 infection using blood samples collected prior to the vaccination and at the end of the 7-month follow-up.
- Adverse events following BCG vaccine [ Time Frame: 7 months ]Adverse events following administration of VPM1002 when used for prevention of COVID-19.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04439045
|Contact: Cynthia Kuk, MSc||416-586-4800 ext firstname.lastname@example.org|
|Contact: Miran Kenk, PhDemail@example.com|
|Principal Investigator:||Alexandre R Zlotta, MD PhD||University Health Network, Toronto|