BCG vaccination to reduce the impact of COVID-19 in healthcare workers
BCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and o...
| Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Fecha de publicación: | 2021 |
| País: | España |
| Institución: | Universitat Autònoma de Barcelona |
| Repositorio: | Dipòsit Digital de Documents de la UAB |
| Idioma: | inglés |
| OAI Identifier: | oai:ddd.uab.cat:282522 |
| Acceso en línea: | https://ddd.uab.cat/record/282522 https://dx.doi.org/urn:doi:10.1136/bmjopen-2021-052101 |
| Access Level: | acceso abierto |
| Palabra clave: | COVID-19 Immunology Infectious diseases Microbiology Virology |
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BCG vaccination to reduce the impact of COVID-19 in healthcare workersProtocol for a randomised controlled trial (BRACE trial)Pittet, Laure F.|||0000-0002-2395-4574Messina, Nicole L.|||0000-0001-8404-4462Gardiner, Kaya|||0000-0001-9796-4567Orsini, FrancescaAbruzzo, VeronicaBannister, Samantha|||0000-0001-7507-3704Bonten, MarcCampbell, John L.|||0000-0002-6752-3493Croda, JulioDalcolmo, Margareth|||0000-0002-6820-1082Elia, Sonja|||0000-0002-6368-189XGermano, Susie|||0000-0001-9924-7545Goodall, CaseyGwee, Amanda|||0000-0003-4016-8986Jamieson, TenayaJardim, Bruno|||0000-0003-3465-7556Kollmann, Tobias R.|||0000-0003-2403-9762Guimarães Lacerda, Marcus Vinícius|||0000-0003-3374-9985Lee, Katherine J.|||0000-0002-8334-0291Legge, DonnaLucas, Michaela|||0000-0001-8881-9990Lynn, David J.|||0000-0003-4664-1404McDonald, Ellie|||0000-0003-2295-4641Manning, Laurens|||0000-0003-4334-5351Munns, Craig F.|||0000-0001-5898-5808Perrett, Kirsten P.|||0000-0002-5683-996XPrat i Aymerich, Cristina|||0000-0001-6974-9165Richmond, Peter|||0000-0001-7562-7228Shann, Frank|||0000-0002-9899-1804Sudbury, EvaVillanueva, Paola|||0000-0002-6504-2979Wood, Nicholas J.Lieschke, KatherineSubbarao, Kanta|||0000-0003-1713-3056Davidson, AndrewCurtis, Nigel|||0000-0003-3446-4594COVID-19ImmunologyInfectious diseasesMicrobiologyVirologyBCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19. This international multicentre phase III randomised controlled trial aims to determine if BCG vaccination reduces the incidence of symptomatic and severe COVID-19 at 6 months (co-primary outcomes) compared with no BCG vaccination. We plan to randomise 10 078 HCWs from Australia, The Netherlands, Spain, the UK and Brazil in a 1:1 ratio to BCG vaccination or no BCG (control group). The participants will be followed for 1 year with questionnaires and collection of blood samples. For any episode of illness, clinical details will be collected daily, and the participant will be tested for SARS-CoV-2 infection. The secondary objectives are to determine if BCG vaccination reduces the rate, incidence, and severity of any febrile or respiratory illness (including SARS-CoV-2), as well as work absenteeism. The safety of BCG vaccination in HCWs will also be evaluated. Immunological analyses will assess changes in the immune system following vaccination, and identify factors associated with susceptibility to or protection against SARS-CoV-2 and other infections. Ethical and governance approval will be obtained from participating sites. Results will be published in peer-reviewed open-access journals. The final cleaned and locked database will be deposited in a data sharing repository archiving system. ClinicalTrials.gov.Universitat Autònoma de Barcelona 22021-01-0120212021-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/282522https://dx.doi.org/urn:doi:10.1136/bmjopen-2021-052101reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2825222026-06-06T12:50:31Z |
| dc.title.none.fl_str_mv |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers Protocol for a randomised controlled trial (BRACE trial) |
| title |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers |
| spellingShingle |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers Pittet, Laure F.|||0000-0002-2395-4574 COVID-19 Immunology Infectious diseases Microbiology Virology |
| title_short |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers |
| title_full |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers |
| title_fullStr |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers |
| title_full_unstemmed |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers |
| title_sort |
BCG vaccination to reduce the impact of COVID-19 in healthcare workers |
| dc.creator.none.fl_str_mv |
Pittet, Laure F.|||0000-0002-2395-4574 Messina, Nicole L.|||0000-0001-8404-4462 Gardiner, Kaya|||0000-0001-9796-4567 Orsini, Francesca Abruzzo, Veronica Bannister, Samantha|||0000-0001-7507-3704 Bonten, Marc Campbell, John L.|||0000-0002-6752-3493 Croda, Julio Dalcolmo, Margareth|||0000-0002-6820-1082 Elia, Sonja|||0000-0002-6368-189X Germano, Susie|||0000-0001-9924-7545 Goodall, Casey Gwee, Amanda|||0000-0003-4016-8986 Jamieson, Tenaya Jardim, Bruno|||0000-0003-3465-7556 Kollmann, Tobias R.|||0000-0003-2403-9762 Guimarães Lacerda, Marcus Vinícius|||0000-0003-3374-9985 Lee, Katherine J.|||0000-0002-8334-0291 Legge, Donna Lucas, Michaela|||0000-0001-8881-9990 Lynn, David J.|||0000-0003-4664-1404 McDonald, Ellie|||0000-0003-2295-4641 Manning, Laurens|||0000-0003-4334-5351 Munns, Craig F.|||0000-0001-5898-5808 Perrett, Kirsten P.|||0000-0002-5683-996X Prat i Aymerich, Cristina|||0000-0001-6974-9165 Richmond, Peter|||0000-0001-7562-7228 Shann, Frank|||0000-0002-9899-1804 Sudbury, Eva Villanueva, Paola|||0000-0002-6504-2979 Wood, Nicholas J. Lieschke, Katherine Subbarao, Kanta|||0000-0003-1713-3056 Davidson, Andrew Curtis, Nigel|||0000-0003-3446-4594 |
| author |
Pittet, Laure F.|||0000-0002-2395-4574 |
| author_facet |
Pittet, Laure F.|||0000-0002-2395-4574 Messina, Nicole L.|||0000-0001-8404-4462 Gardiner, Kaya|||0000-0001-9796-4567 Orsini, Francesca Abruzzo, Veronica Bannister, Samantha|||0000-0001-7507-3704 Bonten, Marc Campbell, John L.|||0000-0002-6752-3493 Croda, Julio Dalcolmo, Margareth|||0000-0002-6820-1082 Elia, Sonja|||0000-0002-6368-189X Germano, Susie|||0000-0001-9924-7545 Goodall, Casey Gwee, Amanda|||0000-0003-4016-8986 Jamieson, Tenaya Jardim, Bruno|||0000-0003-3465-7556 Kollmann, Tobias R.|||0000-0003-2403-9762 Guimarães Lacerda, Marcus Vinícius|||0000-0003-3374-9985 Lee, Katherine J.|||0000-0002-8334-0291 Legge, Donna Lucas, Michaela|||0000-0001-8881-9990 Lynn, David J.|||0000-0003-4664-1404 McDonald, Ellie|||0000-0003-2295-4641 Manning, Laurens|||0000-0003-4334-5351 Munns, Craig F.|||0000-0001-5898-5808 Perrett, Kirsten P.|||0000-0002-5683-996X Prat i Aymerich, Cristina|||0000-0001-6974-9165 Richmond, Peter|||0000-0001-7562-7228 Shann, Frank|||0000-0002-9899-1804 Sudbury, Eva Villanueva, Paola|||0000-0002-6504-2979 Wood, Nicholas J. Lieschke, Katherine Subbarao, Kanta|||0000-0003-1713-3056 Davidson, Andrew Curtis, Nigel|||0000-0003-3446-4594 |
| author_role |
author |
| author2 |
Messina, Nicole L.|||0000-0001-8404-4462 Gardiner, Kaya|||0000-0001-9796-4567 Orsini, Francesca Abruzzo, Veronica Bannister, Samantha|||0000-0001-7507-3704 Bonten, Marc Campbell, John L.|||0000-0002-6752-3493 Croda, Julio Dalcolmo, Margareth|||0000-0002-6820-1082 Elia, Sonja|||0000-0002-6368-189X Germano, Susie|||0000-0001-9924-7545 Goodall, Casey Gwee, Amanda|||0000-0003-4016-8986 Jamieson, Tenaya Jardim, Bruno|||0000-0003-3465-7556 Kollmann, Tobias R.|||0000-0003-2403-9762 Guimarães Lacerda, Marcus Vinícius|||0000-0003-3374-9985 Lee, Katherine J.|||0000-0002-8334-0291 Legge, Donna Lucas, Michaela|||0000-0001-8881-9990 Lynn, David J.|||0000-0003-4664-1404 McDonald, Ellie|||0000-0003-2295-4641 Manning, Laurens|||0000-0003-4334-5351 Munns, Craig F.|||0000-0001-5898-5808 Perrett, Kirsten P.|||0000-0002-5683-996X Prat i Aymerich, Cristina|||0000-0001-6974-9165 Richmond, Peter|||0000-0001-7562-7228 Shann, Frank|||0000-0002-9899-1804 Sudbury, Eva Villanueva, Paola|||0000-0002-6504-2979 Wood, Nicholas J. Lieschke, Katherine Subbarao, Kanta|||0000-0003-1713-3056 Davidson, Andrew Curtis, Nigel|||0000-0003-3446-4594 |
| author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
| dc.contributor.none.fl_str_mv |
Universitat Autònoma de Barcelona |
| dc.subject.none.fl_str_mv |
COVID-19 Immunology Infectious diseases Microbiology Virology |
| topic |
COVID-19 Immunology Infectious diseases Microbiology Virology |
| description |
BCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19. This international multicentre phase III randomised controlled trial aims to determine if BCG vaccination reduces the incidence of symptomatic and severe COVID-19 at 6 months (co-primary outcomes) compared with no BCG vaccination. We plan to randomise 10 078 HCWs from Australia, The Netherlands, Spain, the UK and Brazil in a 1:1 ratio to BCG vaccination or no BCG (control group). The participants will be followed for 1 year with questionnaires and collection of blood samples. For any episode of illness, clinical details will be collected daily, and the participant will be tested for SARS-CoV-2 infection. The secondary objectives are to determine if BCG vaccination reduces the rate, incidence, and severity of any febrile or respiratory illness (including SARS-CoV-2), as well as work absenteeism. The safety of BCG vaccination in HCWs will also be evaluated. Immunological analyses will assess changes in the immune system following vaccination, and identify factors associated with susceptibility to or protection against SARS-CoV-2 and other infections. Ethical and governance approval will be obtained from participating sites. Results will be published in peer-reviewed open-access journals. The final cleaned and locked database will be deposited in a data sharing repository archiving system. ClinicalTrials.gov. |
| publishDate |
2021 |
| dc.date.none.fl_str_mv |
2 2021-01-01 2021 2021-01-01 |
| dc.type.none.fl_str_mv |
Article http://purl.org/coar/resource_type/c_6501 VoR http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| dc.type.openaire.fl_str_mv |
info:eu-repo/semantics/article |
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article |
| dc.identifier.none.fl_str_mv |
https://ddd.uab.cat/record/282522 https://dx.doi.org/urn:doi:10.1136/bmjopen-2021-052101 |
| url |
https://ddd.uab.cat/record/282522 https://dx.doi.org/urn:doi:10.1136/bmjopen-2021-052101 |
| dc.language.none.fl_str_mv |
Inglés eng |
| language_invalid_str_mv |
Inglés |
| language |
eng |
| dc.rights.none.fl_str_mv |
open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/ |
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info:eu-repo/semantics/openAccess |
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open access http://purl.org/coar/access_right/c_abf2 https://creativecommons.org/licenses/by/4.0/ |
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openAccess |
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application/pdf |
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reponame:Dipòsit Digital de Documents de la UAB instname:Universitat Autònoma de Barcelona |
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Universitat Autònoma de Barcelona |
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Dipòsit Digital de Documents de la UAB |
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Dipòsit Digital de Documents de la UAB |
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