BCG Vaccination to Prevent COVID-19

• Status: Withdrawn
• Trial end date: 2021-03-23
• Target enrollment: 0
• Participant gender: All

Summary

The current COVID-19 epidemic threatens to overwhelm the capacity of many countries to meet their populations' health care needs. Although several vaccines specific for SARS-CoV-2 have been or are being developed, these require testing in animal and human safety studies and they are unlikely to be available during the expected peak periods of the growing epidemic. Two groups at especially high risk of infection and disease are front line health care workers working directly with COVID-19 patients and elderly residents of group homes or facilities that provide skilled nursing care to this frail population. Interim measures to protect these groups while we await a high efficacy vaccine are desperately needed.

Based on the capacity of BCG to (1) reduce the incidence of respiratory tract infections in children and adults; (2) exert antiviral effects in experimental models; and (3) reduce viremia in an experimental human model of viral infection, we hypothesize that BCG vaccination may induce (partial) protection against susceptibility to and/or severity of SARS-CoV-2 infection.

This study will evaluate the efficacy of BCG to reduce risk of infection by SARS-CoV-2 and mitigate COVID-19 disease severity in at risk health care providers.

A phase III randomized controlled trial provides the highest validity to answer this research question. Given the immediate threat of the SARS-CoV-2 epidemic the trial has been designed as a pragmatic study with a highly feasible primary endpoint, which can be continuously measured. This allows for the most rapid identification of a beneficial outcome that would allow other at-risk individuals, including the control population, to also benefit from the intervention if and as soon as it has demonstrated efficacy and safety.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Collaborators: Harvard Medical School; Harvard Medical School (HMS and HSDM); Immunization HealthCare Division, Defense Health Agency; Uniformed Services University of the Health Sciences; United States Department of Defense
• Treatments: BCG Vaccine

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