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Using BCG to Protect Senior Citizens During the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04542330
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : November 24, 2020
Sponsor:
Collaborators:
Odense Patient Data Explorative Network
Odense University Hospital
Municipality of Odense
Information provided by (Responsible Party):
Bandim Health Project

Brief Summary:

Background: The virus SARS-CoV-2 has spread rapidly throughout the world. Seniors are at high risk of severe COVID-19 when infected. 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: "trained innate immunity". The investigators hypothesize that BCG vaccination can reduce the risk of COVID-19 and other infections among senior citizens during the COVID-19 pandemic.

Objectives: Primary objective: To reduce senior citizens' risk of acute infection during the COVID-19 pandemic. Secondary objectives: To reduce senior citizens' risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens' risk of self-reported respiratory illness during the COVID-19 pandemic.

Study design: A placebo-controlled randomized trial. Study population: 1900 seniors 65 years of age or above. Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline).

Outcomes: Primary outcome: "Acute infection" identified either by a doctor, antibiotics use, hospitalization, or death due to infection. Secondary outcomes: Verified SARS-CoV-2 infection and self-reported respiratory illness.

With an expected incidence of "acute infection" of 20%, the trial can show a 25% risk reduction in the the intervention group versus the placebo group by including a total of 1900 individuals, 950 individuals in each group.

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. If BCG can reduce the risk of acute infection in seniors by 25% it has tremendous public health importance, both during the COVID-19 pandemic and overall.


Condition or disease Intervention/treatment Phase
Covid19 Non-specific Effects of Vaccines Heterologous Immunity Morbidity Immunosenescence Vaccine Preventable Disease Biological: BCG-Denmark Biological: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo-controlled randomized 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.
Primary Purpose: Prevention
Official Title: Using BCG Vaccine to Enhance Non-specific Protection of Senior Citizens During the COVID-19 Pandemic. A Randomized Clinical Trial.
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BCG-Denmark

Participants that are randomized to the active comparator 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 dose of vaccine contains between 200,000 to 800,000 colony forming units of the live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.

Biological: BCG-Denmark
Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) administered by intradermal injection in the left deltoid region.
Other Names:
  • BCG-1331
  • BCG-AJ
  • BCG-SSI

Placebo Comparator: Control
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.
Biological: Saline
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.
Other Name: NaCl




Primary Outcome Measures :
  1. Acute infection [ Time Frame: 12 months after inclusion ]
    Acute infection identified either by a doctor, antibiotics use, hospitalization or death due to infection.


Secondary Outcome Measures :
  1. SARS-CoV-2 infection [ Time Frame: 12 months after inclusion ]
    SARS-CoV-2 IgM/IgG antibodies

  2. Self-reported respiratory illness [ Time Frame: 12 months after inclusion ]
    Self-reported respiratory illness is based on information on symptoms given by the participants in the biweekly questionnaire.



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Ages Eligible for Study:   65 Years to 110 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

• In order to be eligible to participate in this study, a subject must meet the following criteria: ≥65 years old.

Exclusion Criteria:

  • Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration
  • Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species
  • Previous confirmed COVID-19 infection
  • Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection
  • Vaccination with other live attenuated vaccine within the last 4 weeks
  • Severely immunocompromised subjects. This exclusion category comprises:
  • Subjects with known infection with the human immunodeficiency virus (HIV)
  • Subjects with solid organ transplantation or bone marrow transplantation
  • Subjects under chemotherapy
  • Subjects with primary immunodeficiency
  • Treatment with any anti-cytokine therapy within the last year
  • Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months
  • Active solid or non-solid malignancy or lymphoma within the prior two years
  • Subjects who do not have access to e-Boks.

Information from the National Library of Medicine

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): NCT04542330


Contacts
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Contact: Anne Marie Rosendahl Madsen, MD 22 56 31 34 ext 45 arosendahl@health.sdu.dk
Contact: Christine Stabell Benn, DMSc 25 88 39 64 ext +45 cbenn@health.sdu.dk

Locations
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Denmark
Seniorhuset Recruiting
Odense, Denmark, 5000
Contact: Anne Marie Rosendahl Madsen         
Sponsors and Collaborators
Bandim Health Project
Odense Patient Data Explorative Network
Odense University Hospital
Municipality of Odense
Investigators
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Principal Investigator: Anne Marie Rosendahl Madsen, MD Bandim Health Project, Department of Clinical Research, Uni. Southern Denmark
Study Chair: Christine Stabell Benn, DMSc Bandim Health Project, Department of Clinical Research, Uni. Southern Denmark
Publications:
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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT04542330    
Other Study ID Numbers: BCG-DENMARK-SENIOR
First Posted: September 9, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Non-identifiable individual data can be shared on the basis of a data sharing proposal sent to cbenn@health.sdu.dk
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: When follow-up has been completed and the dataset have been closed
Access Criteria: Per justified request on email (cbenn@health.sdu.dk)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No