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Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity (COBRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04439045
Recruitment Status : Not yet recruiting
First Posted : June 19, 2020
Last Update Posted : June 19, 2020
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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3626 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
Estimated Study Start Date : June 14, 2020
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : June 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 self-reported positive COVID-19 test, subsequently confirmed by review of medical records.

  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 self-reported positive COVID-19 test, subsequently confirmed by review of medical records.

  3. 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.

  4. 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

  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. 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.


Other Outcome Measures:
  1. 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.

  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 ]
    Adverse events following administration of VPM1002 when used for prevention of COVID-19.



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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
  • Front-line employee of provincial or municipal police force
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
  • Previous known history of latent or active tuberculosis
  • 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.
  • 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


Contacts
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Contact: Cynthia Kuk, MSc 416-586-4800 ext 3910 cynthia.kuk@sinaihealth.ca
Contact: Miran Kenk, PhD miran.kenk@uhn.ca

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: June 19, 2020
Last Verified: June 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