Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland

• Status: Recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes.

The aim of the study is to answer the following questions:

1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)?

2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects?

3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result?

A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking*.

Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19.

• to measure the level of cytokines involved in cell-mediated immunity process

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hanna Czajka
• Collaborator: Medical Research Agency - Agencja Badań Medycznych

Criteria

Inclusion Criteria:

• a health care professional (physician, nurse, midwife, paramedic, electroradiology technician, laboratory diagnostician, physiotherapist, nutritionist, orderly) aged >25 years

• no confirmed SARS-CoV-2 infection

• informed consent to participate in the trial and consent to personal data processing

• declared availability for telephone contacts throughout the study period

• good health condition

• earlier vaccination against tuberculosis

Exclusion Criteria:

• hypersensitivity to any component of BCG-10

• hypersensitivity to previously administered tuberculin (local skin lesions, necrosis of the skin, blisters, other severe skin reactions at the injection site)

• HIV infection (confirmed or suspected infections, even if they are asymptomatic)

• primary or secondary immunodeficiencies (including interferon - gamma deficiency or DiGeorge syndrome)

• radiotherapy (less than 24 months before the date of inclusion in the trial

• treatment with corticosteroids, ongoing immunosuppressive therapy (including those treated with monoclonal antibodies to TNF-α, such as infliximab) - less than 24 months before the date of inclusion in the trial

• neoplastic diseases (e.g. leukaemia, malignant granuloma, lymphoma or some other cancer of the reticuloendothelial system) - less than 24 months before the date of inclusion in the study

• after stem cell transplantation and organ transplantation

• in the exacerbation stage of chronic diseases (including severe malnutrition)

• pregnancy

• history of tuberculosis

• keloid at the vaccination site after previous BCG vaccination