BCG Vaccine for Health Care Workers as Defense Against COVID 19

NCT04348370 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2020-0432F
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 6

Brief Summary

SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

Conditions

Coronavirus; Coronavirus Infection; Coronavirus as the Cause of Diseases Classified Elsewhere

Keywords

BACILLUS CALMETTE-GUÉRIN VACCINATION; BCG Vaccine; Coronavirus; SARS-CoV-2; COVID19; COVID

Outcome Measures

Primary Outcomes (1)

• Number of New COVID 19 Infections

  The primary outcome measure is development of COVID19 infection. This will be reported as the number of individuals receiving the intervention who are PCR-positive or seroconvert, defined as number of new cases during the 6 month time period

  6 months

Secondary Outcomes (1)

• Disease Severity

  6 months

Study Arms (2)

BCG Group

EXPERIMENTAL

FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing \~1x10\^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (\~2x10\^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.

Biological: BCG Vaccine

Placebo Group

PLACEBO COMPARATOR

A single dose will consist of 0.1 mL saline

Biological: Placebo Vaccine

Interventions

BCG Vaccine BIOLOGICAL

BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.

BCG Group

Placebo Vaccine BIOLOGICAL

Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years)
• Male or female
• Hospital personnel taking care for patients with known or suspected SARS-CoV-2 infection and providing, on average, at least 25 hours per week of direct patient care

You may not qualify if:

• Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
• Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
• Fever (\>38 C) within the past 24 hours
• Age \> 75 years
• Pregnancy or planning pregnancy within 30 days of study enrollment
• Breastfeeding
• Suspicion of active viral or bacterial infection
• Living with someone who is immunosuppressed or taking immunosuppressive drugs
• Previous documented infection with COVID19
• Active solid or non-solid malignancy or lymphoma within the prior two years
• Direct involvement in the design or the execution of the study
• Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
• Not in possession of a smartphone
• Inability to keep the vaccine site covered in the case of a draining pustule.

Sponsors & Collaborators

• Texas A&M University: lead
• Baylor College of Medicine: collaborator
• M.D. Anderson Cancer Center: collaborator
• Cedars-Sinai Medical Center: collaborator
• Harvard University: collaborator

Study Sites (6)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Texas A&M Family Care Clinic

Bryan, Texas, 77802, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Baylor St. Luke's Medical Center

Houston, Texas, 77030, United States

Location

Harris Health System - Ben Taub Hospital

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Jeffrey D. Cirillo
• Organization: Texas A&M University College of Medicine

jdcirillo@tamu.edu

979-436-0343

Study Officials

• Jeffrey D Cirillo, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Andrew DiNardo, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Ashish M Kamat, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Moshe Arditi, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be done centrally and computer generated with stratification per hospital in random blocks of 2, 4 and 6. The BCG vaccine will be administered by research nurses. Participants and investigators will be blinded. The research nurse that administers the BCG vaccine or placebo will not be blinded. This research nurse will not be involved in the collection of outcome data.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to BCG:placebo in a 1:1 ratio.

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 16, 2020
• Study Start: April 20, 2020
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: October 8, 2024
• Results First Posted: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)