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
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