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A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results

Tuberculosis vaccines (Bacillus Calmette-Guérin, BCG) were introduced 100 years ago and are still recommended by the World Health Organization to prevent the disease. Studies have shown that BCG vaccination can stimulate non-specific immune responses and reduce the incidence of certain diseases. At...

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Autores principales: Czajka, Hanna, Zapolnik, Paweł, Krzych, Łukasz, Kmiecik, Wojciech, Stopyra, Lidia, Nowakowska, Anna, Jackowska, Teresa, Darmochwał-Kolarz, Dorota, Szymański, Henryk, Radziewicz-Winnicki, Igor, Mazur, Artur
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8879775/
https://www.ncbi.nlm.nih.gov/pubmed/35214772
http://dx.doi.org/10.3390/vaccines10020314
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author Czajka, Hanna
Zapolnik, Paweł
Krzych, Łukasz
Kmiecik, Wojciech
Stopyra, Lidia
Nowakowska, Anna
Jackowska, Teresa
Darmochwał-Kolarz, Dorota
Szymański, Henryk
Radziewicz-Winnicki, Igor
Mazur, Artur
author_facet Czajka, Hanna
Zapolnik, Paweł
Krzych, Łukasz
Kmiecik, Wojciech
Stopyra, Lidia
Nowakowska, Anna
Jackowska, Teresa
Darmochwał-Kolarz, Dorota
Szymański, Henryk
Radziewicz-Winnicki, Igor
Mazur, Artur
author_sort Czajka, Hanna
collection PubMed
description Tuberculosis vaccines (Bacillus Calmette-Guérin, BCG) were introduced 100 years ago and are still recommended by the World Health Organization to prevent the disease. Studies have shown that BCG vaccination can stimulate non-specific immune responses and reduce the incidence of certain diseases. At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, it was hypothesised that the incidence of COVID-19 was lower in countries with BCG prevention. In an attempt to verify this thesis, we conducted a multicenter, randomised, double-blind, placebo-controlled study on a group of 695 health care workers aged 25 years and over in Poland. All participants in the study had a tuberculin test, after which those who were negative were randomised (1:1) and received either the BCG- or placebo vaccine. From then on, these people were subjected to three months of observation for the occurrence of COVID-19 symptoms. The statistical analysis did not reveal any significant correlation between the frequency of incidents suspected of COVID-19 and BCG-10 vaccination, the result of the tuberculin test and the number of scars. The only statistically significant feature was the type of medical profession—nurses became infected more often than doctors or other medical workers (p = 0.02). The results differ from similar trials in other countries. Perhaps this is due to the lack of an unvaccinated control group. The impact of BCG vaccination on the course of COVID-19 requires further research.
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spelling pubmed-88797752022-02-26 A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results Czajka, Hanna Zapolnik, Paweł Krzych, Łukasz Kmiecik, Wojciech Stopyra, Lidia Nowakowska, Anna Jackowska, Teresa Darmochwał-Kolarz, Dorota Szymański, Henryk Radziewicz-Winnicki, Igor Mazur, Artur Vaccines (Basel) Article Tuberculosis vaccines (Bacillus Calmette-Guérin, BCG) were introduced 100 years ago and are still recommended by the World Health Organization to prevent the disease. Studies have shown that BCG vaccination can stimulate non-specific immune responses and reduce the incidence of certain diseases. At the beginning of the coronavirus disease 2019 (COVID-19) pandemic, it was hypothesised that the incidence of COVID-19 was lower in countries with BCG prevention. In an attempt to verify this thesis, we conducted a multicenter, randomised, double-blind, placebo-controlled study on a group of 695 health care workers aged 25 years and over in Poland. All participants in the study had a tuberculin test, after which those who were negative were randomised (1:1) and received either the BCG- or placebo vaccine. From then on, these people were subjected to three months of observation for the occurrence of COVID-19 symptoms. The statistical analysis did not reveal any significant correlation between the frequency of incidents suspected of COVID-19 and BCG-10 vaccination, the result of the tuberculin test and the number of scars. The only statistically significant feature was the type of medical profession—nurses became infected more often than doctors or other medical workers (p = 0.02). The results differ from similar trials in other countries. Perhaps this is due to the lack of an unvaccinated control group. The impact of BCG vaccination on the course of COVID-19 requires further research. MDPI 2022-02-17 /pmc/articles/PMC8879775/ /pubmed/35214772 http://dx.doi.org/10.3390/vaccines10020314 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Czajka, Hanna
Zapolnik, Paweł
Krzych, Łukasz
Kmiecik, Wojciech
Stopyra, Lidia
Nowakowska, Anna
Jackowska, Teresa
Darmochwał-Kolarz, Dorota
Szymański, Henryk
Radziewicz-Winnicki, Igor
Mazur, Artur
A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results
title A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results
title_full A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results
title_fullStr A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results
title_full_unstemmed A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results
title_short A Multi-Center, Randomised, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Impact of BCG Re-Vaccination on the Incidence and Severity of SARS-CoV-2 Infections among Symptomatic Healthcare Professionals during the COVID-19 Pandemic in Poland—First Results
title_sort multi-center, randomised, double-blind, placebo-controlled phase iii clinical trial evaluating the impact of bcg re-vaccination on the incidence and severity of sars-cov-2 infections among symptomatic healthcare professionals during the covid-19 pandemic in poland—first results
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8879775/
https://www.ncbi.nlm.nih.gov/pubmed/35214772
http://dx.doi.org/10.3390/vaccines10020314
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