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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 : Active, not recruiting
First Posted : June 19, 2020
Last Update Posted : March 22, 2021
Sponsor:
Collaborators:
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Verity Pharmaceuticals
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Biological: VPM1002 Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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
Actual Study Start Date : June 24, 2020
Estimated Primary Completion Date : September 2, 2021
Estimated Study Completion Date : December 1, 2021

Arm Intervention/treatment
Experimental: VPM1002
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.
Biological: VPM1002
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.
Other: Placebo
0.9% sodium chloride
Other Name: sodium chloride




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Incidence of hospitalization for COVID-19 [ Time Frame: 7 months ]
    To compare the incidence of hospitalization in participants with positive COVID-19 test treated with either VPM1002 or placebo

  2. 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 positive COVID-19 test treated with either VPM1002 or placebo

  3. Incidence of ARDS [ Time Frame: 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.

  4. Mechanical ventilation for COVID-19 [ Time Frame: 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.

  5. 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.

  6. 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.

  7. Incidence of DVT [ Time Frame: 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.


Other Outcome Measures:
  1. Incidence of COVID-19 in Participants with Past BCG Vaccination [ Time Frame: 7 months ]
    To compare the incidence of COVID-19 in participants who have received BCG vaccination previously vs those not previously vaccinated

  2. 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.

  3. Adverse events following BCG vaccine [ Time Frame: 7 months ]
    To compare adverse event profile in participants following administration of VPM1002 or placebo when used for prevention of COVID-19.

  4. Innate Trained Immunity [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Serum Institute of India Pvt. Ltd.
Max Planck Institute for Infection Biology
Verity Pharmaceuticals
Investigators
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Principal Investigator: Alexandre R Zlotta, MD PhD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04439045    
Other Study ID Numbers: 20-5413
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases