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

NCT04439045 | Completed Phase 3 DMC

• 1 other identifier: 20-5413
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• COVID-19 infection

  To compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo.

  7 months

Secondary Outcomes (7)

• Incidence of hospitalization for COVID-19

  7 months

• Incidence of ICU admission for COVID-19

  7 months

• Incidence of ARDS

  7 months

• Mechanical ventilation for COVID-19

  7 months

• Secondary infection in COVID-19

  7 months

Other Outcomes (4)

• Incidence of COVID-19 in Participants with Past BCG Vaccination

  7 months

• 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

• Adverse events following BCG vaccine

  7 months

Study Arms (2)

VPM1002

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

A single dose of 0.1 mL of the 0.9% sodium chloride injection, administered via intradermal injection.

Other: Placebo

Interventions

VPM1002 BIOLOGICAL

VPM1002 is a recombinant BCG (rBCG)

Also known as: Mycobacterium bovis rBCGΔureC::hly

VPM1002

Placebo OTHER

0.9% sodium chloride

Also known as: sodium chloride

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Serum Institute of India Pvt. Ltd.: collaborator
• Max Planck Institute for Infection Biology: collaborator
• Verity Pharmaceuticals Inc.: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Constantin AM, Noertjojo K, Sommer I, Pizarro AB, Persad E, Durao S, Nussbaumer-Streit B, McElvenny DM, Rhodes S, Martin C, Sampson O, Jorgensen KJ, Bruschettini M. Workplace interventions to reduce the risk of SARS-CoV-2 infection outside of healthcare settings. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD015112. doi: 10.1002/14651858.CD015112.pub3.

  PMID: 38597249 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

VPM1002 recombinant BCG vaccine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Alexandre R Zlotta, MD PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 19, 2020
• Study Start: June 24, 2020
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)