BCG Vaccination to Prevent COVID-19

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.

Conditions

• COVID-19

Interventions

DRUG

Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine

Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine will be diluted in preservative-free saline and given intradermally (0.1mL) in the deltoid area.

DRUG

Preservative-free saline

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.

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Uniformed Services University of the Health Sciences

  collaborator FED

• United States Department of Defense

  collaborator FED

• Defense Health Agency

  collaborator FED

• Henry M. Jackson Foundation for the Advancement of Military Medicine

  lead OTHER

Principal Investigators

• Jeffrey R Livezey, MD · Uniformed Services University of the Health Sciences

• Naomi E Aronson · Uniformed Services University of the Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-07

Primary Completion

2021-03-23

Completion

2021-03-23

FDA Drug

Yes