Using BCG Vaccine to Protect Health Care Workers in the COVID-19 Pandemic
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|ClinicalTrials.gov Identifier: NCT04373291|
Recruitment Status : Active, not recruiting
First Posted : May 4, 2020
Last Update Posted : February 2, 2021
Background: The COVID-19 pandemic challenges the available hospital capacity, and this will be augmented by absenteeism of healthcare workers (HCW). HCW are at high risk, currently HCW constitute 20% of all the COVID-19 cases in Denmark. Strategies to prevent absenteeism of HCW are urgently needed.
Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified.
We hypothesize that BCG vaccination can reduce HCW absenteeism during the COVID-19 pandemic.
Primary objective: To reduce absenteeism among HCW with direct patient contacts during the COVID-19 epidemic. Secondary objective: To reduce the number of HCW that are infected with SARS-CoV-2 during the COVID-19 epidemic and to reduce the number of hospital admissions amongst HCW with direct patient contacts during the COVID-19 epidemic.
Study design: A multi-center randomized placebo controlled trial. Study population: 1500 HCW with direct patient contacts; defined as nurses, physicians and other medical staff working at emergency rooms and wards where COVID-infected patients are treated.
Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline).
Main study parameters/endpoints: Primary endpoint: Number of days of (unplanned) absenteeism for any reason. Secondary endpoints: Number of days of (unplanned) absenteeism because of documented COVID infection. Cumulative incidence of hospital admissions.
Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the potential beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of COVID infection.
|Condition or disease||Intervention/treatment||Phase|
|COVID-19 Non-specific Effects of Vaccines Morbidity Absenteeism Heterologous Immunity||Biological: BCG-Denmark Biological: Saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1293 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A multi-center randomized placebo-controlled trial|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Participants will be blinded to treatment. The physicians administering the BCG vaccine or placebo will not be blinded. In case of serious adverse events, the participant can be unblinded after consultation with the coordinating PI or sponsor.|
|Official Title:||Using BCG Vaccine to Enhance Non-specific Protection of Health Care Workers During the COVID-19 Pandemic. A Randomized Controlled Multi-center Trial|
|Actual Study Start Date :||May 18, 2020|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Active Comparator: BCG vaccine
Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (BCG-Denmark, AJ Vaccines) in the skin covering the left upper deltoid muscle.
Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units of the live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.
Participants randomized to receive BCG will receive one 0.1 ml dose of Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) by intradermal injection in the left deltoid region.
Placebo Comparator: Control
Placebo will be 0.1 ml sterile 0.9 % NaCl, which has a similar color as the resuspended BCG vaccine.
Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.
- Number of days of unplanned absenteeism for any reason [ Time Frame: 6 months ]
- The cumulative incidence of documented COVID [ Time Frame: 6 months ]
- The cumulative incidence of hospital admission for any reason [ Time Frame: 6 months ]
- The number of days of unplanned absenteeism, because of documented COVID [ Time Frame: 6 months ]
- The number of days of absenteeism, because of imposed quarantine as a result of exposure to SARS-CoV-2 [ Time Frame: 6 months ]
- The number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented SARS- CoV-2 infection [ Time Frame: 6 months ]
- The number of days of unplanned absenteeism because of self-reported acute respiratory symptoms [ Time Frame: 6 months ]
- The number of days of self-reported fever (≥38 °C) [ Time Frame: 6 months ]
- The number of days of self-reported acute respiratory symptoms [ Time Frame: 6 months ]
- The cumulative incidence of self-reported acute respiratory symptoms [ Time Frame: 6 months ]
- The cumulative incidence of death for any reason [ Time Frame: 6 months ]
- The cumulative incidence of death due to documented COVID [ Time Frame: 6 months ]
- The cumulative incidence of Intensive Care Admission for any reason [ Time Frame: 6 months ]
- The cumulative incidence of Intensive Care Admission due to documented COVID [ Time Frame: 6 months ]
- The cumulative incidence of Hospital Admission due to documented COVID [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373291
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Frederik Schaltz-Buchholzer, MD||Bandim Health Project, University of Southern Denmark|
|Principal Investigator:||Anne Marie Rosendahl Madsen, MD||Bandim Health Project, University of Southern Denmark|
|Study Chair:||Christine Stabell Benn, Professor||Bandim Health Project, University of Southern Denmark|