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

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.

Conditions

• Covid19
• Non-specific Effects of Vaccines
• Heterologous Immunity
• Morbidity
• Immunosenescence
• Vaccine Preventable Disease

Interventions

BIOLOGICAL

BCG-Denmark

Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) administered 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.

Sponsors & Collaborators

• Odense Patient Data Explorative Network

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Municipality of Odense

  collaborator OTHER_GOV

• Bandim Health Project

  lead OTHER

Principal Investigators

• Anne Marie Rosendahl Madsen, MD · Bandim Health Project, Department of Clinical Research, Uni. Southern Denmark

• Christine Stabell Benn, DMSc · Bandim Health Project, Department of Clinical Research, Uni. Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-15

Primary Completion

2023-01-11

Completion

2023-01-11

Countries

• Denmark

Study Locations