TY - JOUR
T1 - BCG vaccination to reduce the impact of COVID-19 in healthcare workers
T2 - Protocol for a randomised controlled trial (BRACE trial)
AU - Pittet, Laure F.
AU - Messina, Nicole L.
AU - Gardiner, Kaya
AU - Orsini, Francesca
AU - Abruzzo, Veronica
AU - Bannister, Samantha
AU - Bonten, Marc
AU - Campbell, John
AU - Croda, Julio
AU - Dalcolmo, Margareth
AU - Elia, Sonja
AU - Germano, Susie
AU - Goodall, Casey
AU - Gwee, Amanda
AU - Jamieson, Tenaya
AU - Jardim, Bruno
AU - Kollmann, Tobias R.
AU - Lacerda, Marcus Vinícius Guimarães
AU - Lee, Katherine J.
AU - Legge, Donna
AU - Lucas, Michaela
AU - Lynn, David J.
AU - McDonald, Ellie
AU - Manning, Laurens
AU - Munns, Craig F.
AU - Perrett, Kirsten P.
AU - Prat Aymerich, Cristina
AU - Richmond, Peter
AU - Shann, Frank
AU - Sudbury, Eva
AU - Villanueva, Paola
AU - Wood, Nicholas J.
AU - Lieschke, Katherine
AU - Subbarao, Kanta
AU - Davidson, Andrew
AU - Curtis, Nigel
AU - BRACE Trial Consortium Group
AU - Abreu, Carolinne
AU - Addlem, Lynne
AU - Agius, Sophie
AU - Barbosa, Adelita Agripina Refosco
AU - Alamrousi, Ahmed
AU - da Silva dos Santos, Ayla Alcoforado
AU - Al-Hindawi, Yasmeen
AU - Da Silveira, Samyra Almeida
AU - da Cruz, Lais Alves
AU - Anderson, Jeremy
AU - Anthony, Christina
AU - de Almeida dos Reis Pereira, Andrea Antonia Souza
AU - de las Revillas Almajano, Francisco Arnaiz
AU - Arnold, Annabelle
AU - Arrowsmith, Beth
AU - Azzopardi, Kristy
AU - Marti, Cristina Badia
AU - Bahaduri, Twinkle
AU - Barney, Sarah
AU - Barrera, Lydia
AU - Barriocanal, Anabel
AU - Barros, Dayanne
AU - Bartlett, Adam
AU - Batista Silva Muranaka, Lilian
AU - Baulman, Therese
AU - Bealing, Morgan
AU - Beardsley, Justin
AU - Belen Martin Gutierrez, Ana
AU - Bell, Jason
AU - Bennett-Wood, Vicki
AU - Bergant, Nikki
AU - Barbosa, Fabiane Bianca
AU - Bijllaardt, Wouter
AU - Bimboese, Patricia
AU - Bitencourt de Andrade, Camila
AU - Blauwendraat, Kitty
AU - Boersma, Wim
AU - Bohedo Garcia, Pilar
AU - Bonnici, Rhian
AU - Boon, Anne
AU - Bourke, Anna
AU - Bowes, Kirsty
AU - Brasil, Larissa
AU - Brophy, Clare
AU - Buchanan, Sandy
AU - Bucholc, Jess
AU - Burns, Alison
AU - Burrell, Emma
AU - Bustos, Natalia
AU - Byrne, Bridie
AU - Byrne, Anthony
AU - Calbo, Esther
AU - Calvo Montes, Jorge
AU - Camesella, Beatriz
AU - Cangas, Atsegiñe
AU - Carlin, John
AU - Roque, Maria Carmen
AU - Diogo, Roberta Carolina Pereira
AU - Carvalho, Estela
AU - Casas, Irma
AU - Castro, Erika
AU - Castro, Roman
AU - Catterick, Helen
AU - Escobar, Rodrigo Cezar Dutra
AU - Chan, Joyce
AU - Cheah, Jo
AU - Chengodu, Thilakavathi
AU - Ciaverella, Marianna
AU - Clarke, Sharon
AU - Espindola, Marie-Alix Clement
AU - Cobbledick, Annie
AU - Colaco, Clinton
AU - Collopy, Simone
AU - Comella, Patricia
AU - Corbett, Mary
AU - Correa E Castro, Gabriela
AU - Costa, Erlane
AU - Coya, Raquel
AU - Crawford, Nigel
AU - Cruz, Alda
AU - Cushnahan, Jac
AU - Czajko, Anna
AU - da Costa Silva, Renato
AU - Daitiri, Bouchra
AU - Dalton, Karen
AU - Dao, Aiken
AU - Dawe, Phoebe
AU - Dawson, Diane
AU - de Jesus Costa, Miriam
AU - De La Cruz, Karina
AU - de la Serna, Almudena
AU - de Morais Batista, Fabiani
AU - de Oliveira, Adriely
AU - del Alba Rey Morillo, Rocio
AU - Desylva, Maria
AU - Dijkstra, Helga
AU - Dixon, Rachel
AU - del Toro Lopez, Maria Dolores
AU - Dominguez, Jose
AU - Dominguez Castellano, Angel
AU - Dos Santos, Glauce
AU - dos Santos Lencina, Joyce
AU - dos Santos Silva, Débora
AU - Douglas, Mark
AU - Dunn, Ross
AU - Dunn, Andrew
AU - Dunnill, Jemma
AU - Edmund, Harriet
AU - Eiffler, Nat
AU - Elborough, Hannah
AU - Elkington, Olivia
AU - England, Michelle
AU - Ayala, Wellyngthon Espindola
AU - Esteve, Maria
AU - Evans, Nick
AU - Ewe, Krist
AU - Fariñ Álvarez, María Carmen
AU - Fairweather, Kieran FaheyJill
AU - Faustman, Denise
AU - Fernandes Silva, Erica
AU - Fernandez, Monique
AU - Fidler, Galina
AU - Filius, P.M.G
AU - Finn, Adam
AU - Finucane, Carolyn
AU - Firth, Stephanie
AU - Fletcher, Emily
AU - Flynn, Catherine
AU - Flynn, Lorraine
AU - Fouracre, Liam
AU - Fowler, Sarah
AU - Freitas, Thamires
AU - Furtado, Ana Carolina
AU - Oliveira, Maria Gabriela
AU - Santos, Anna Gabriela
AU - Gonçalves, Leandro Galdino Cavalcanti
AU - Galletta, Laura
AU - Gama, Larissa
AU - Gamage, Dinusha
AU - Ganpat, Radhika
AU - Garcia, Mariana
AU - Garcia, Carlos
AU - Croda, Mariana Garcia
AU - Gardiner, Evangeline
AU - Gell, Grace
AU - de Oliveira, Aline Gerhardt
AU - Gibbons, Michael
AU - Gibson, Camille
AU - Gifford, Alison
AU - Poderos, Teresa Giménez
AU - Ginsberg, Ann
AU - Gisolf, Jet
AU - Gladanac, Bojana
AU - Glenn, Penny
AU - Godinho, Vanessa
AU - Góes dos Santos, Mayara
AU - Goikoetxea, Josune
AU - Goldenberg, Telma
AU - Gomes, Adriano
AU - Marcos, Susana Gonzalez
AU - Rico, Claudia González
AU - Gordon, Victoria
AU - Greven, Frances
AU - Capella, Ana Greyce
AU - Guo, Christina
AU - Campos, David Gutierrez
AU - Cuadra, Manuel Gutierrez
AU - Hall, Richard
AU - Hall, Lydia
AU - Hamilton, Kate
AU - Hannan, Matthew
AU - Harbech, Houda
AU - Harding, Alex
AU - Harker, Neil
AU - Harrison, Robert
AU - Hassing, Robert Jan
AU - Souza da Rosa, Thaynara Haynara
AU - Haywood, Zaheerah
AU - Henare, Nadine
AU - Andrade, Paulo Henrique
AU - Herrmann, Susan
AU - Hill, Erin
AU - Hilton, Sam
AU - Huijbens, Danique
AU - Hutton, Heidi
AU - Janssen, Axel
AU - Jardim, Tyane
AU - Jarvis, Lance
AU - Jenkins, Narelle
AU - Jones, Jane
AU - Jones, Jan
AU - Jones, Karen
AU - Jorge, Leticia
AU - Rios Vilegas, Maria Jose
AU - Joshi, Sri
AU - Joyce, Rosemary
AU - Junior, Joel
AU - Kandasamy, Rama
AU - Karunanayake, Anushka
AU - Karuppasamy, Hana
AU - Keeble, Tom
AU - Kent, Jennifer
AU - Kloeg, Paul
AU - Kluytmans, Jan
AU - Knight, Bridget
AU - Korman, Tony
AU - Krastev, Ann
AU - La, Nathan
AU - Lacoma, Alicia
AU - Lagunday, Renier
AU - Lalich, Debbie
AU - Latkovic, Erin
AU - Latorre, Irene
AU - Meireles Junior, Paulo Leandro Garcia
PY - 2021/10
Y1 - 2021/10
N2 - Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
AB - Introduction 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. Methods and analysis 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. Ethics and dissemination 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.
KW - COVID-19
KW - immunology
KW - infectious diseases
KW - microbiology
KW - virology
UR - http://www.scopus.com/inward/record.url?scp=85118958887&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-052101
DO - 10.1136/bmjopen-2021-052101
M3 - Article
AN - SCOPUS:85118958887
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - e052101
ER -
