Cargando…
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...
Autores principales: | , , , , , , , , , , |
---|---|
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 |
_version_ | 1784658986381869056 |
---|---|
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. |
format | Online Article Text |
id | pubmed-8879775 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT czajkahanna amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT zapolnikpaweł amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT krzychłukasz amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT kmiecikwojciech amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT stopyralidia amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT nowakowskaanna amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT jackowskateresa amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT darmochwałkolarzdorota amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT szymanskihenryk amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT radziewiczwinnickiigor amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT mazurartur amulticenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT czajkahanna multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT zapolnikpaweł multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT krzychłukasz multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT kmiecikwojciech multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT stopyralidia multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT nowakowskaanna multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT jackowskateresa multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT darmochwałkolarzdorota multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT szymanskihenryk multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT radziewiczwinnickiigor multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults AT mazurartur multicenterrandomiseddoubleblindplacebocontrolledphaseiiiclinicaltrialevaluatingtheimpactofbcgrevaccinationontheincidenceandseverityofsarscov2infectionsamongsymptomatichealthcareprofessionalsduringthecovid19pandemicinpolandfirstresults |