Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses

Who is this study for? Adult patients with COVID-19 Infection
What treatments are being studied? Bacillus of Calmette-Guerin Vaccine
Status: Active, not recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Adult (≥18 years)

• Male or female

• Hospital personnel taking care for patients with known or suspected SARS-CoV-2 infection and providing, on average, at least 25 hours per week of direct patient care

Locations
United States
California
Cedars-Sinai Medical Center
Los Angeles
Texas
Texas A&M Family Care Clinic
Bryan
Baylor College of Medicine
Houston
Baylor St. Luke's Medical Center
Houston
Harris Health System - Ben Taub Hospital
Houston
MD Anderson Cancer Center
Houston
Time Frame
Start Date: April 20, 2020
Estimated Completion Date: May 2023
Participants
Target number of participants: 1800
Treatments
Experimental: BCG Group
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing ~1x10^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (~2x10^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
Placebo Comparator: Placebo Group
A single dose will consist of 0.1 mL saline
Authors
Seth Lerner, Andrew DiNardo, Anna Mandalakas, Megan Murray, Ashish Kamat, Jeffrey D Cirillo, Megan D Murray, Moshe Arditi
Sponsors
Leads: Texas A&M University
Collaborators: Baylor College of Medicine, M.D. Anderson Cancer Center, Cedars-Sinai Medical Center, Harvard University

This content was sourced from clinicaltrials.gov

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