CompletedPhase 3

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

Denmark1,700 participantsStarted 2020-09-15

Plain-language 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.

Who can participate

Age range65 Years – 110 Years

SexALL

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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.

What they're measuring

Acute Infection

Timeframe: 12 months after inclusion

Trial details

NCT IDNCT04542330

SponsorBandim Health Project

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-11

Results submitted2024-03-26