Texas A&M intensified its battle against the novel coronavirus as tuberculosis expert Dr. Jeffrey Cirillo leads a group of world-renown institutions in a clinical trial that could potentially deliver a SARS-CoV-2 treatment within six months. This group represents one of a number of investigators worldwide pursuing an existing tuberculosis vaccine known as BCG, which has been around for decades. There is actually data that leads some to hypothesize that a BCG vaccine can mitigate COVID-19 infection. The first clinical investigational site with federal approval to test the vaccine on humans in a clinical trial targeting COVID-19, they are at work recruiting and vaccinating health workers in College Station and Houston. Others collaborators include Cedars Sinai, MD Anderson, Harvard and Baylor.
As SARS-CoV-2 spreads around the world, the pandemic challenged the available hospital capacity—matters get worse when healthcare workers become infected by the pathogen. Hence, strategies to prevent infection and disease severity of healthcare workers are 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%.
TrialSite News showcased a similar Massachusetts General Hospital study and highlighted that a pattern of COVID-19-based mortality could be correlated to the lack of systematic BCG testing. Texas A&M is following the same research trajectory noting in preliminary analysis that regions with existing BCG vaccination appear to have lower SARS-CoV-2-caused mortality rates. That study is led by Dr. Denise Faustman, Director of immunobiology.
Hence, the investigators led by Texas A&M believe that BCG vaccination can reduce healthcare worker infection and disease severity during an epidemic phase of SARS-CoV-2, the virus behind the COVID-19 pandemic.
This study will use FDA-approved BCG Tice strain, procured from Merck. The vaccine will be reconstituted according to the package insert. IN brief, a viral containing ~1×10^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL(~2×10^5 CFU) will be administered by slow intradermal injection using a 25 gauge/0.5 mm syringe in the deltoid area.
Sponsored by Texas A&M, the Aggie-led team includes some prominent company such as Baylor College of Medicine (Houston, TX), MD Anderson Cancer Center (Houston, Tx), Cedars-Sinai Medical Center (Los Angeles, CA) and Harvard University (Cambridge, MA). The study commenced on April 20, 2020 and will run through until November 2021.
Participants will be randomized via a centralized computer software (e.g. IXRS) generating a stratification per hospital in random blocks of 2,4 and 6. The BCG vaccine will be administered by research nurses. Participants and investigators will be blinded. The research nurse that administers the BCG vaccine or placebo will not be blinded. The research nurse will not be involved in the collection of outcome data.
Primary outcome measures centers on the development of a COVID-19 infection. The study team will employ Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert—defined as number of new cases during the six-month study period.
Other BCG Studies
On April 9, TrialSite News found three (3) BCG studies focusing on the COVID-19 connection. Now just weeks later, that figure has doubled with six (6) clinical trials testing the BCG and COVID-19 premise. Two new studies opened up in Egypt, including one sponsored by Ain Shams University, led by Iman Hassan, MD and another one sponsored by Assiut University and led by a professor of pulmonology named Aliae AR Mohamed-Hussein.
Jefferey D. Cirillo, PhD, Regents Professor, Department of Microbial Pathogenesis and Immunology
Professor Cirillo has over 30 years of experience researching tuberculosis related science. At the helm of a research team, they employ both animal and molecular models to understand airborne pathogens and to develop novel prevention, treatment and diagnostic strategies to improve global health. Dr. Cirillo leads the Center for Airborne Pathogens Research and Tuberculosis Image Resources (CAPRI) formed in 2007 and the Small Animal Model Vaccines and Pathogenesis (SAMVAP) group. In addition to this latest important BCM research, he has been awarded over $5 million from the Bill Melinda Gates Foundation’s Global Health Program and currently has over $1 million from NIH, supporting ongoing work such as real-time optical imaging and detection of tuberculosis.
Andrew Dinardo, MD, Assistant Professor Baylor College of Medicine
Other Research Site Investigators
Moshe Arditi, MD, Cedars-Sinai
Megan Murray, MD, MPH, Harvard
Seth Lerner, MD, Baylor St. Lukes Medical Center
Anna Marie Mandalakas, MD, Baylor College of Medicine
Ashish Kamat, MD, MD Anderson Cancer Center
Call to Action: An important study, there is a growing call to consider the BCM strategy against the novel coronavirus. Sign for TrialSite News daily newsletter to keep up with all of the moving pieces.