SARS-CoV-2 Infection
Conditions
Brief summary
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 workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They 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 in Ontario.
Interventions
BIOLOGICALVPM1002
VPM1002 is a recombinant BCG (rBCG)
OTHERPlacebo
0.9% sodium chloride
Sponsors
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Verity Pharmaceuticals Inc.
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Eighteen years of age or older * Employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility
Exclusion criteria
* Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood. * Previous known history of latent or active tuberculosis * Known kidney, liver or blood disorders which impairs organ and marrow function * Chronic administration of steroids (\>10 mg prednisone) at the time of randomization * Current or planned concomitant biologic therapy in the next 7 months. * Known hypersensitivity or allergy to components of VPM1002 * Pregnant or planning to become pregnant in the future 7 months. * Breastfeeding. * Current suspected viral or bacterial infection. * Body temperature \> 38° C * Participation in another interventional study with potentially conflicting medication within 30 days before screening. * The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-TNF therapy, methotrexate, azathioprine, antimalarials). * Active malignancy requiring treatment. * Known positive HIV serology. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine. * Previous positive COVID-19 confirmed infection. * Uncontrolled intercurrent illness. * Psychiatric illness/social situations that would limit compliance with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 infection | 7 months | To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ARDS | 7 months | To compare the 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 | 7 months | To compare the incidence of the need for mechanical ventilation in participants with positive COVID-19 test treated with either VPM1002 or placebo. |
| Secondary infection in COVID-19 | 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 | 7 months | To compare the mortality in participants with positive COVID-19 test treated with either VPM1002 or placebo. |
| Incidence of DVT | 7 months | To compare the incidence of deep vein thrombosis, pulmonary embolism, or stroke in participants with positive COVID-19 test treated with either VPM1002 or placebo. |
| Incidence of hospitalization for COVID-19 | 7 months | To compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo |
| Incidence of ICU admission for COVID-19 | 7 months | To compare the incidence of hospitalization requiring intensive care (ICU admission) in participants with positive COVID-19 test treated with either VPM1002 or placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events following BCG vaccine | 7 months | To compare adverse event profile in participants following administration of VPM1002 or placebo when used for prevention of COVID-19. |
| Innate Trained Immunity | 7 months | Compare the priming of the innate trained immunity (i.e. induction of Th1 and Th17 responses to unrelated stimuli) in participants following administration of VPM1002 or placebo when used for prevention of COVID-19. |
| Incidence of COVID-19 in Participants with Past BCG Vaccination | 7 months | To compare the incidence of COVID-19 in participants who have received BCG vaccination previously vs those not previously vaccinated |
| 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 | 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. |
Countries
Canada
Outcome results
None listed