BCG Vaccination to Prevent COVID-19

NCT04632537 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: USUHS.2020-062
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

COVID-19; BCG; vaccine; clinical trial

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic rt-PCR-confirmed SARS-CoV-2 infection

  The primary outcome measure is the development of symptomatic COVID 19 infections. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of COVID-19. This will be reported as the incidence of rt-PCR-confirmed symptomatic SARS-CoV-2 infection following BCG vaccination compared to that following placebo, starting from 3 days post-vaccination through 6 months.

  6 months

Secondary Outcomes (4)

• incidence of Serology-confirmed infection with SARS-CoV-2

  6 months

• severity of COVID-19 disease

  6 months

• symptomatic respiratory infection

  6 months

• effect of prior adult immunization with other vaccines associated with trained immunity

  6 months

Study Arms (2)

TICE BCG (for intravesical use, Merck) BCG LIVE

ACTIVE COMPARATOR

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.

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

placebo vaccine

PLACEBO COMPARATOR

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.

Drug: Preservative-free saline

Interventions

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

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.

TICE BCG (for intravesical use, Merck) BCG LIVE

Preservative-free saline DRUG

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.

placebo vaccine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)\*
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Harvard Medical School (HMS and HSDM): collaborator
• Uniformed Services University of the Health Sciences: collaborator
• United States Department of Defense: collaborator
• Defense Health Agency: collaborator

Related Publications (41)

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MeSH Terms

Conditions

COVID-19

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Jeffrey R Livezey, MD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

• Naomi E Aronson

  Uniformed Services University of the Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 17, 2020
• Study Start: December 7, 2020
• Primary Completion: March 23, 2021
• Study Completion: March 23, 2021
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share