BCG Vaccine for Health Care Workers as Defense Against COVID 19

Completed · Phase 4 · Has a placebo group

Conditions studied: Coronavirus, Coronavirus Infection, Coronavirus as the Cause of Diseases Classified Elsewhere

In brief

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.

Key facts

Study ID

NCT04348370

Run by

Texas A&M University

People needed

659

Starts

2020-04-20

Expected to finish

2023-04-21

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
• Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
• Fever (>38 C) within the past 24 hours
• Age > 75 years
• Pregnancy or planning pregnancy within 30 days of study enrollment
• Breastfeeding
• Suspicion of active viral or bacterial infection
• Any Immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with known neutropenic with less than 1500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) known severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
• Living with someone who is immunosuppressed or taking immunosuppressive drugs
• Previous documented infection with COVID19
• Active solid or non-solid malignancy or lymphoma within the prior two years
• Direct involvement in the design or the execution of the study
• Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
• Not in possession of a smartphone
• Inability to keep the vaccine site covered in the case of a draining pustule.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Texas A&M Family Care Clinic — Bryan, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• Harris Health System - Ben Taub Hospital — Houston, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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