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

Phase 3

Completed

• Conditions: SARS-CoV-2 Infection
• Interventions: Other: Placebo; Biological: VPM1002

• Registration Number: NCT04439045
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-18
• Study First Posted: 2020-06-19
• Study Start: 2020-06-24
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	A single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection.
VPM1002	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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 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.
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 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
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.

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada