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Randomized Controlled Trial Multicenter Study Journal Article Epublish 3 citations

PubMed: 37794431 DOI: 10.1186/s13063-023-07662-w

Bacillus Calmette-Guérin vaccination as defense against SARS-CoV-2 (BADAS): a randomized controlled trial to protect healthcare workers in the USA by enhanced trained immune responses.

Trials 24(1):636

Authors: Andrew R DiNardo, Moshe Arditi, Ashish M Kamat, Kent J Koster, Santiago Carrero, Tomoki Nishiguchi, Maxim Lebedev, Aaron B Benjamin, Pablo Avalos, Marisa Lozano, Madeleine G Moule, Brittany McCune, Baysia Herron, Malik Ladki, Daanish Sheikh, Matthew Spears, Ivan A Herrejon, Courtney Dodge, Sathish Kumar, Robert W Hutchison, Theresa U Ofili, Lynne A Opperman, Jessica A Bernard, Seth P Lerner, George Udeani, Gabriel Neal, Mihai G Netea, Jeffrey D Cirillo

Affiliations

  • Global and Immigrant Health, Baylor College of Medicine, Houston, TX, 77030, USA.
  • Radboud Center for Infectious Diseases, Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.
  • Departments of Pediatrics and Biomedical Sciences, Cedars-Sinai Medical Center, Los Angeles, CA, 90048, USA.
  • Department of Urology, UT MD Anderson Cancer Center, Houston, TX, 77030, USA.
  • Center for Airborne Pathogen Research and Imaging, Texas A&M School of Medicine, Bryan, TX, 77807, USA.
  • Cedars-Sinai Medical Center, Regenerative Medicine Institute, Los Angeles, CA, 90048, USA.
  • Institute of Immunology & Infection Research, School of Biological Sciences, University of Edinburgh, Edinburgh, UK.
  • Texas A&M School of Medicine, Bryan, TX, 77807, USA.
  • College of Osteopathic Medicine, Sam Houston State University, Conroe, TX, 77304, USA.
  • Department of Psychological and Brain Sciences, Texas A&M University, College Station, TX, 77843, USA.
  • Texas A&M School of Medicine, Round Rock, TX, 78665, USA.
  • Department of Pharmacy Practice, Texas A&M School of Pharmacy, College Station, TX, 77843, USA.
  • Center for Craniofacial Research and Diagnosis, Texas A&M School of Dentistry, Dallas, TX, 75246, USA.
  • Department of Psychological and Brain Sciences, Texas A&M Institute for Neuroscience, Texas A&M University, College Station, TX, 77843, USA.
  • Scott Department of Urology, Baylor College of Medicine, Houston, TX, 77030, USA.
  • Department of Pharmacy Practice, Texas A&M School of Pharmacy, Kingsville, TX, 78363, USA.
  • Primary Care and Rural Medicine, Texas A&M School of Medicine, Bryan, TX, 77807, USA.
  • Radboud University Medical Center, Nijmegen, The Netherlands.
  • Center for Airborne Pathogen Research and Imaging, Texas A&M School of Medicine, Bryan, TX, 77807, USA.

Abstract

BACKGROUND

A large epidemic, such as that observed with SARS-CoV-2, seriously challenges available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in vitro and in vivo. Preliminary analyses suggest that regions of the world with existing BCG vaccination programs have lower incidence and mortality from COVID-19. We hypothesize that BCG vaccination can reduce SARS-CoV-2 infection and disease severity.

METHODS

This will be a placebo-controlled adaptive multi-center randomized controlled trial. A total of 1800 individuals considered to be at high risk, including those with comorbidities (hypertension, diabetes, obesity, reactive airway disease, smokers), racial and ethnic minorities, elderly, teachers, police, restaurant wait-staff, delivery personnel, health care workers who are defined as personnel working in a healthcare setting, at a hospital, medical center or clinic (veterinary, dental, ophthalmology), and first responders (paramedics, firefighters, or law enforcement), will be randomly assigned to two treatment groups. The treatment groups will receive intradermal administration of BCG vaccine or placebo (saline) with groups at a 1:1 ratio. Individuals will be tracked for evidence of SARS-CoV-2 infection and severity as well as obtaining whole blood to track immunological markers, and a sub-study will include cognitive function and brain imaging. The majority of individuals will be followed for 6 months, with an option to extend for another 6 months, and the cognitive sub-study duration is 2 years. We will plot Kaplan-Meier curves that will be plotted comparing groups and hazard ratios and p-values reported using Cox proportional hazard models.

DISCUSSION

It is expected this trial will allow evaluation of the effects of BCG vaccination at a population level in high-risk healthcare individuals through a mitigated clinical course of SARS-CoV-2 infection and inform policy making during the ongoing epidemic.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04348370. Registered on April 16, 2020.

MeSH

Sars-Cov-2, Vaccines, Bacillus, Vaccination, Covid-19, Health Personnel, Immunity, Therapeutics, Severe Acute Respiratory Syndrome-Related Coronavirus, Randomized Controlled Trials As Topic, Epidemics, Infections

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