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BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial)
Version 2 2024-10-20, 00:07
Version 1 2024-08-20, 06:41
journal contribution
posted on 2024-10-20, 00:07 authored by Laure F Pittet, Nicole L Messina, Kaya Gardiner, Francesca Orsini, Veronica Abruzzo, Samantha Bannister, Marc Bonten, John L Campbell, Julio Croda, Margareth Dalcolmo, Sonja Elia, Susie Germano, Casey Goodall, Amanda Gwee, Tenaya Jamieson, Bruno Jardim, Tobias R Kollmann, Marcus Lacerda, Katherine J Lee, Donna Legge, Michaela Lucas, David J Lynn, Ellie McDonald, Laurens Manning, Craig F Munns, Kirsten P Perrett, Cristina Prat Aymerich, Peter Richmond, Frank Shann, Eva Sudbury, Paola Villanueva, Nick Wood, Katherine Lieschke, Kanta Subbarao, Andrew Davidson, Nigel Curtis, Carolinne Abreu, Lynne Addlem, Sophie Agius, Adelita Agripina Refosco Barbosa, Ahmed Alamrousi, Ayla Alcoforado da Silva dos Santos, Yasmeen Al-Hindawi, Samyra Almeida Da Silveira, Lais Alves da Cruz, Jeremy Anderson, Christina Anthony, Andrea Antonia Souza de Almeida dos Reis Pereira, Francisco Arnaiz de las Revillas Almajano, Annabelle Arnold, Beth Arrowsmith, Kristy Azzopardi, Cristina Badia Marti, Twinkle Bahaduri, Sarah Barney, Lydia Barrera, Ana Maria Barriocanal, Dayanne Barros, Adam Bartlett, Lilian Batista Silva Muranaka, Therese Baulman, Morgan Bealing, Justin Beardsley, Ana Belen Martin Gutierrez, Jason Bell, Vicki Bennett-Wood, Nikki Bergant, Fabiane Bianca Barbosa, Wouter Bijllaardt, Patricia Bimboese, Camila Bitencourt de Andrade, Kitty Blauwendraat, Wim Boersma, Pilar Bohedo Garcia, Rhian Bonnici, Anne Boon, Anna Bourke, Kirsty Bowes, Larissa Brasil, Clare Brophy, Sandy Buchanan, Jessica BucholcJessica Bucholc, Alison Burns, Emma Burrell, Natalia Bustos, Bridie Byrne, Anthony Byrne, Esther Calbo, Jorge Calvo Montes, Beatriz Camesella, John Campbell, Atsegiñe Cangas, John Carlin, Maria Carmen Roque, Roberta Carolina Pereira Diogo, Estela Carvalho, Irma Casas, Erika Castro, Ramon Castro, Helen Catterick, Rodrigo Cezar Dutra Escobar, Joyce Chan, Jo Cheah, Thilakavathi Chengodu, Marianna Ciaverella, Sharon Clark, Marie Alix Clement Espindola, Annie Cobbledick, Clinton Colaco, Simone Collopy, Patricia Comella, Mary Corbett, Gabriela Correa E Castro, Erlane Costa, Raquel Coya, Nigel Crawford, Alda Cruz, Jac Cushnahan, Anna Czajko, Renato da Costa Silva, Bouchra Daitiri, Karen Dalton, Aiken Dao, Phoebe Dawe, Diane Dawson, Miriam de Jesus Costa, Karina De La Cruz, Almudena de la Serna, Fabiani de Morais Batista, Adriely de Oliveira, Rocio del Alba Rey Morillo, Maria Desylva, Helga Dijkstra, Rachel Dixon, Maria Dolores del Toro Lopez, Jose Dominguez, Angel Dominguez Castellano, Glauce Dos Santos, Joyce dos Santos Lencina, Débora dos Santos Silva, Mark Douglas, Ross Dunn, Andrew Dunn, Jemma Dunnill, Harriet Edmund, Nat Eiffler, Hannah Elborough, Olivia Elkington, Michelle England, Wellyngthon Espindola Ayala, Maria Esteve, Nick Evans, Krist Ewe, María Carmen Fariñ Álvarez, Kieran Fahey Jill Fairweather, Denise Faustman, Erica Fernandes Silva, Monique Fernandez, Galina Fidler, PMG Filius, Adam Finn, Carolyn Finucane, Stephanie Firth, Emily Fletcher, Catherine Flynn, Lorraine Flynn, Liam Fouracre, Sarah Fowler, Thamires Freitas, Ana Carolina Furtado, Maria Gabriela Oliveira, Anna Gabriela Santos, Leandro Galdino Cavalcanti Gonçalves, Laura Galletta, Larissa Gama, Dinusha Gamage, Radhika Ganpat, Mariana Garcia, Carlos García, Mariana Garcia Croda, Evangeline Gardiner, Grace Gell, Aline Gerhardt de Oliveira, Michael Gibbons, Camille Gibson, Alison Gifford, Teresa Giménez Poderos, Ann Ginsberg, Jet Gisolf, Bojana Gladanac, Penny Glenn, Vanessa Godinho, Mayara Góes dos Santos, Josune Goikoetxea, Telma Goldenberg, Adriano Gomes, Susana Gonzalez Marcos, Claudia González Rico, Victoria Gordon, Frances Greven, Ana Greyce Capella, Christina Guo, David Gutierrez Campos, Manuel Gutierrez Cuadra, Richard Hall, Lydia Hall, Kate Hamilton, Matthew Hannan, Houda Harbech, Alex Harding, Neil Harker, Robert Harrison, Robert Jan Hassing, Thaynara Haynara Souza da Rosa, Zaheerah Haywood, Nadine Henare, Paulo Henrique Andrade, Susan Herrmann, Erin Hill, Sam Hilton, Danique Huijbens, Heidi Hutton, Axel Janssen, Tyane Jardim, Lance Jarvis, Narelle Jenkins, Jane Jones, Jan Jones, Karen Jones, Leticia Jorge, Maria Jose Rios Vilegas, Sri Joshi, Rosemary Joyce, Joel Junior, Rama Kandasamy, Anushka Karunanayake, Hana Karuppasamy, Tom Keeble, Jennifer Kent, Paul Kloeg, Jan Kluytmans, Bridget Knight, Tobias Kollmann, Tony Korman, Ann Krastev, Nathan La, Alicia Lacoma, Renier Lagunday, Debbie Lalich, Erin Latkovic, Irene Latorre, Paulo Leandro Garcia Meireles, Katherine Lee, Toos Lemmers, Titia Leurink, Kee Lim, Gemma Lockhart, Cíntia Lopes Bogéa, Karla Lopes dos Santos, Reyes Lopez Marques, Maria Luciana Silva De Freitas, Norine Ma, Sam Macalister, Cristiane Machado, Matheus Machado Ramos, Francesca Machingaifa, Ivan Maia, Bernardo Maia, Richard Malley, Sarah Manton, Jose Manuel Carrerero, Cíntia Maria Lopes Alves, Rosa Maria Plácido Pereira, Bianca Maria Silva Menezes Arruda, Adriana Marins, Christopher Martin, Katya Martinez Almeida, Wayne Mather, Megan Mathers, Fábio Mauricio Nogueira Gomes, Mariana Mayumi Tadokoro, Nadia Mazarakis, Kelry Mazurega, Sonia McAlister, Amy McAndrews, Fiona McDonald, Rebecca McElroy, Brendan McMullan, Nick McPhate, Lee Mead, Andrea Meehan, Bob Meek, Rosangela Melo, Guillermo Mena, Daniella Mesquita, Isabella Mezzetti, Hugo Miguel Ramos Vieira, Skye Miller, Kirsten Mitchell, Marcus Mitchell, Jesutofunmi Mojeed, Kitty Molenaar, Gemma Molina, Barbara Molina, Lisa Montgomery, Cecilia Moore, James Moore, Simone Moorlag, Thilanka Morawakage, Julie Moss, Will Moyle, Kim Mulholland, Craig Munns, Elizandra Nascimento, Nicolas Navarrette, Mihai Netea, Juliana Neves, Georgina Newman, Belle Ngien, Jill Nguyen, Khanh Nguyen, Fran Noonan, Wendy Norton, Melissa O'Donnell, Jess O'Bryan, Abby O'Connell, Sasha Odoi, Liz O'Donnell, Roberto Oliveira, Marilena Oliveira, Thais Oliveira, Ingrid Oliveira, Nadia Olivier, Ligia Olivio, Benjamin Ong, Jaslyn Ong, Joanne Ong, Jakob Onysk, Isabelle Ooi, Frances Oppedisano, Belinda Ortika, Orygen Group, Arthur Otsuka, Kristen Overton, Rosie Owens, Rayssa Paes, Pamela Palasanthiran, Virginia Palomo Jiménez, Girlene Pandine, Kimberley Parkin, Alvaro Pascual Hernandez, Nienke Paternotte, David Paterson, Ana Paula Conceição de Souza, Lisa Pelayo, Casey Pell, Sille Pelser, Handerson Pereira, Gabrielle Pereira, Glady Perez, Cristina Perez, Tomás Perez Porcuna, Susan PerlenSusan Perlen, Amandine Philippart De Floy, Sigrid Pitkin, RC Pon, Ines Portillo Calderón, Jeffrey Post, Catherine Power, Christiane Prado, Endriaen Prajitno, Lieke Preijers, Marco Puga, Evelyn Queiroz, Lynne Quinn, Ashleigh Rak, Leticia Ramires Figueiredo, Encarnacion Ramirez de Arellano, Pedro Ramos, Karla Regina Warszawski de Oliveira, Jack Ren, Stephanie Reynolds, Shelley Rhodes, Claudinalva Ribeiro dos Santos, Chris Richards, Holly Richmond, Ana Rita Lopes Souza, Jorge Rocha, Teresa Rodrigues, Laleyska Rodrigues, Bebeto Rodrigues, Iara Rodrigues Fernandes, Jesús Rodríguez-Baño, Nienke Roescher, Sally Rogers, Anke Rol, Jannie Romme, Antoni Rosell, Maria Roser Font, Sonia Sallent, Vanderson Sampaio, Nuria Sanchez, Blanca Sanchez, Daniel Santos, Tilza Santos, Ariandra Sartim, Amber Sastry, Alice Sawka, Nikki Schultz, Clare Seamark, David Seamark, Engelien Septer-Bijleveld, Raquel Serrano, Ketaki Sharma, Margaret Shave, Lisa Shen, Kate Sidaway-Lee, Adrian Siles Baena, Rafaela Silva, Juliana Silva, Emanuelle Silva, Mariana Simão, Ronita Singh, Marilda Siqueira, Marciléia Soares D Allão Chaves, Thijs Sondag, Enoshini Sooriyarachchi, Antonny Sousa, Leena Spry, Sarah Statton, Andrew Steer, Dyenyffer Stéffany Leopoldina dos Santos, Katrina Sterling, Leah Steve, Luke Stevens, Carolyn Stewart, Lisa Stiglmayer, Lida Stooper, Josephine Studham, Astrid Suiker, Lorrie Symons, Esther Taks, Niki Tan, Bruna Tayara Leopoldina Meireles, Mennote Riele, Jaap ten Oever, Guilherme Teodoro de Lima, Rob ter Heine, Jhenyfer Thalyta Campos Angelo, Helen Thomson, Ryan Toh, Alexandre Trindade, Harry Tripp, Enriqueta Tristán, Darren Troeman, Alexandra Truelove, Daniel Tsuha, Marlot Uffing, Fernando Val, Olga Valero, Ester Valls, Chantal van de Ven, Leo Van Den Heuvel, Sigrid van der Veen, Marije van der Waal, JH van Leusen, Linda van Mook, H van Onzenoort, Marjoleine van Opdorp, Miranda van Rijen, Nicolette van Sluis, Adria Vasconcelos, Noelia Vega, Sunitha Velagapudi, Louise Vennells, Tamsin Venton, Harald Verheij, PM Verhoeven, Caroliny Veron Ramos, Paulo Victor Rocha da Silva, Sandra Vidal, Patricia Vieira, Matheus Vieira de Oliveira, Rosario Vigo Ortega, Raquel Villar, Amanda Vlahos, Ushma Wadia, Kate Wall, Rachael Wallace, Justin Waring, Ruth Warren, Adilia Warris, Emma Watts, Michelle Wearing-Smith, Daniel Webber-Rookes, Jamie Wedderburn, Ashleigh Wee-Hee, Jia Wei TeoIntroductionBCG 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 analysisThis 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 disseminationEthical 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.Trial registrationClinicalTrials.gov NCT04327206
