BCG Vaccination to Prevent COVID-19 (NUEVA)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, BCG, vaccine, clinical trial
Eligibility Criteria
Inclusion Criteria:
- Physicians, physician assistants, nurse practitioners, nurses, medics, respiratory therapists and other HCWs who are likely to care for patients with COVID-19 illness
- Eligible for care in DoD facilities (DEERS eligible)*
- 18-64 years old
- Willingness to permit review of medical records
- Women of childbearing potential must be willing to use an effective form of birth control for 30 days post vaccination
Exclusion Criteria:
- Previously (medical history) or currently infected or ill with COVID-19
- Previous TB disease
- Fever (>38 C) within the past 24 hours
- Currently pregnant or breastfeeding or planning on becoming pregnant within 30 days of enrollment
Current serious underlying medical conditions including: diabetes mellitus, chronic kidney disease, or any other immunocompromising condition:
- Known infection by Human Immunodeficiency Virus (HIV)
- History of solid organ or bone marrow transplantation
- Currently under chemotherapy
- Currently on any anti-cytokine therapy
- History of immunodeficiency (including history of anti B cell therapy)
- Currently taking immunosuppressive drugs
- Treatment with oral or intravenous steroids, defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
- Active solid or non-solid malignancy or lymphoma within the past two years
- Suspicion of active viral or bacterial infection
- Living with someone HIV+, who is immunocompromised, or is taking an immunosuppressive drug
- Known allergy to (components of) the BCG vaccine or a serious reaction to prior BCG administration
- Plan to terminate their employment at the participating health care facility or change duty stations within the next three months
- Not in possession of a smartphone
- Current participation in a COVID-19 interventional trial
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
TICE BCG (for intravesical use, Merck) BCG LIVE
placebo vaccine
Participants randomized to the BCG arm will receive Tice® BCG (for intravesical use) BCG LIVE is a live freeze-dried vaccine made from an attenuated strain of Mycobacterium bovis. The freeze-dried vaccine will be delivered in vials, each containing 1 to 8 x108 colony forming units (CFU). Tice® BCG (for intravesical use) BCG LIVE will be reconstituted in ~5 mL of preservative-free saline, as needed for yielding 2- x107 CFU/ mL. [34] Administration of 0.1 mL will contain 2x106 CFU, which accounts for approximately 0.1 mg of the attenuated Mycobacterium bovis. Administration of 0.1 mL of diluted vaccine will be given per dose, intradermally. A sterile tuberculin 1mL syringe and sterile fine short needle (25 or 26 gauge with 3/8-3/4 length), will be used for each injection. The injection should be made slowly after inserting the needle ~2 mm into the superficial layer of the dermis of the upper arm (usually deltoid area), to make a symmetrical superficial bleb.
Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm. Placebo will comprise 0.1 mL of the diluent (preservative-free saline) to ensure the same quantity and same color as the resuspended BCG vaccine, rendering the two indistinguishable.