Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context

Summary: Background: Recurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects. Methods...

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Main Authors:	Laure F. Pittet, Cecilia L. Moore, Ellie McDonald, Simone Barry, Marc Bonten, John Campbell, Julio Croda, Margareth Dalcolmo, Andrew Davidson, Mark W. Douglas, Kaya Gardiner, Amanda Gwee, Bruno Jardim, Marcus V.G. Lacerda, Michaela Lucas, David J. Lynn, Laurens Manning, Roberto D. de Oliveira, Kirsten P. Perrett, Cristina Prat-Aymerich, Peter C. Richmond, Jorge L. Rocha, Jesus Rodriguez-Baño, Adilia Warris, Nicholas J. Wood, Nicole L. Messina, Nigel Curtis, Tenaya Jamieson, Nicole Messina, Thilanka Morawakage, Susan Perlen, Kirsten Perrett, Laure Pittet, Amber Sastry, Jia Wei Teo, Francesca Orsini, Katherine Lee, Cecilia Moore, Suzanna Vidmar, Rashida Ali, Ross Dunn, Peta Edler, Grace Gell, Casey Goodall, Richard Hall, Ann Krastev, Nathan La, Nick McPhate, Thao Nguyen, Jack Ren, Luke Stevens, Ahmed Alamrousi, Rhian Bonnici, Thanh Dang, Susie Germano, Jenny Hua, Rebecca McElroy, Monica Razmovska, Scott Reddiex, Xiaofang Wang, Jeremy Anderson, Kristy Azzopardi, Vicki Bennett-Wood, Anna Czajko, Nadia Mazarakis, Conor McCafferty, Frances Oppedisano, Belinda Ortika, Casey Pell, Leena Spry, Ryan Toh, Sunitha Velagapudi, Amanda Vlahos, Ashleigh Wee-Hee, Pedro Ramos, Karina De La Cruz, Dinusha Gamage, Anushka Karunanayake, Isabella Mezzetti, Benjamin Ong, Ronita Singh, Enoshini Sooriyarachchi, Suellen Nicholson, Natalie Cain, Rianne Brizuela, Han Huang, Veronica Abruzzo, Morgan Bealing, Patricia Bimboese, Kirsty Bowes, Emma Burrell, Joyce Chan, Jac Cushnahan, Hannah Elborough, Olivia Elkington, Kieran Fahey, Monique Fernandez, Catherine Flynn, Sarah Fowler, Marie Gentile Andrit, Bojana Gladanac, Catherine Hammond, Norine Ma, Sam Macalister, Emmah Milojevic, Jesutofunmi Mojeed, Jill Nguyen, Liz O'Donnell, Nadia Olivier, Isabelle Ooi, Stephanie Reynolds, Lisa Shen, Barb Sherry, Judith Spotswood, Jamie Wedderburn, Angela Younes, Donna Legge, Jason Bell, Jo Cheah, Annie Cobbledick, Kee Lim, Sonja Elia, Lynne Addlem, Anna Bourke, Clare Brophy, Nadine Henare, Narelle Jenkins, Francesca Machingaifa, Skye Miller, Kirsten Mitchell, Sigrid Pitkin, Kate Wall, Paola Villanueva, Nigel Crawford, Wendy Norton, Niki Tan, Thilakavathi Chengodu, Diane Dawson, Victoria Gordon, Tony Korman, Jess O'Bryan, Sophie Agius, Samantha Bannister, Jess Bucholc, Alison Burns, Beatriz Camesella, John Carlin, Marianna Ciaverella, Maxwell Curtis, Stephanie Firth, Christina Guo, Matthew Hannan, Erin Hill, Sri Joshi, Katherine Lieschke, Megan Mathers, Sasha Odoi, Ashleigh Rak, Chris Richards, Leah Steve, Carolyn Stewart, Eva Sudbury, Helen Thomson, Emma Watts, Fiona Williams, Angela Young, Penny Glenn, Andrew Kaynes, Amandine Philippart De Floy, Sandy Buchanan, Thijs Sondag, Ivy Xie, Harriet Edmund, Bridie Byrne, Tom Keeble, Belle Ngien, Fran Noonan, Michelle Wearing-Smith, Alison Clarke, Pemma Davies, Oliver Eastwood, Alric Ellinghaus, Rachid Ghieh, Zahra Hilton, Emma Jennings, Athina Kakkos, Iris Liang, Katie Nicol, Sally O'Callaghan, Helen Osman, Gowri Rajaram, Sophia Ratcliffe, Victoria Rayner, Ashleigh Salmon, Angela Scheppokat, Aimee Stevens, Rebekah Street, Nicholas Toogood, Nicholas Wood, Twinkle Bahaduri, Therese Baulman, Jennifer Byrne, Candace Carter, Mary Corbett, Aiken Dao, Maria Desylva, Andrew Dunn, Evangeline Gardiner, Rosemary Joyce, Rama Kandasamy, Craig Munns, Lisa Pelayo, Ketaki Sharma, Katrina Sterling, Caitlin Uren, Clinton Colaco, Mark Douglas, Kate Hamilton, Adam Bartlett, Brendan McMullan, Pamela Palasanthiran, Phoebe Williams, Justin Beardsley, Nikki Bergant, Renier Lagunday, Kristen Overton, Jeffrey Post, Yasmeen Al-Hindawi, Sarah Barney, Anthony Byrne, Lee Mead, Marshall Plit, David Lynn, Saoirse Benson, Stephen Blake, Rochelle Botten, Tee Yee Chern, Georgina Eden, Liddy Griffith, Jane James, Miriam Lynn, Angela Markow, Domenic Sacca, Natalie Stevens, Steve Wesselingh, Catriona Doran, Alice Sawka, Sue Evans, Louise Goodchild, Christine Heath, Meredith Krieg, Helen Marshall, Mark McMillan, Mary Walker, Peter Richmond, Nelly Amenyogbe, Christina Anthony, Annabelle Arnold, Beth Arrowsmith, Rym Ben-Othman, Sharon Clark, Jemma Dunnill, Nat Eiffler, Krist Ewe, Carolyn Finucane, Lorraine Flynn, Camille Gibson, Lucy Hartnell, Elysia Hollams, Heidi Hutton, Lance Jarvis, Jane Jones, Jan Jones, Karen Jones, Jennifer Kent, Tobias Kollmann, Debbie Lalich, Wenna Lee, Rachel Lim, Sonia McAlister, Fiona McDonald, Andrea Meehan, Asma Minhaj, Lisa Montgomery, Melissa O'Donnell, Jaslyn Ong, Joanne Ong, Kimberley Parkin, Glady Perez, Catherine Power, Shadie Rezazadeh, Holly Richmond, Sally Rogers, Nikki Schultz, Margaret Shave, Patrycja Skut, Lisa Stiglmayer, Alexandra Truelove, Ushma Wadia, Rachael Wallace, Justin Waring, Michelle England, Erin Latkovic, Susan Herrmann, Marcus Lacerda, Paulo Henrique Andrade, Fabiane Bianca Barbosa, Dayanne Barros, Larissa Brasil, Ana Greyce Capella, Ramon Castro, Erlane Costa, Dilcimar de Souza, Maianne Dias, José Dias, Klenilson Ferreira, Paula Figueiredo, Thamires Freitas, Ana Carolina Furtado, Larissa Gama, Vanessa Godinho, Cintia Gouy, Daniele Hinojosa, Tyane Jardim, Joel Junior, Augustto Lima, Bernardo Maia, Adriana Marins, Kelry Mazurega, Tercilene Medeiros, Rosangela Melo, Marinete Moraes, Elizandra Nascimento, Juliana Neves, Maria Gabriela Oliveira, Thais Oliveira, Ingrid Oliveira, Arthur Otsuka, Rayssa Paes, Handerson Pereira, Gabrielle Pereira, Christiane Prado, Evelyn Queiroz, Laleyska Rodrigues, Bebeto Rodrigues, Vanderson Sampaio, Anna Gabriela Santos, Daniel Santos, Tilza Santos, Evelyn Santos, Ariandra Sartim, Ana Beatriz Silva, Juliana Silva, Emanuelle Silva, Mariana Simão, Caroline Soares, Antonny Sousa, Alexandre Trindade, Fernando Val, Adria Vasconcelos, Heline Vasconcelos, Carolinne Abreu, Katya Martinez Almeida, Camila Bitencourt de Andrade, Jhenyfer Thalyta Campos Angelo, Ghislaine Gonçalvez de Araújo Arcanjo, Bianca Maria Silva Menezes Arruda, Wellyngthon Espindola Ayala, Adelita Agripina Refosco Barbosa, Felipe Zampieri Vieira Batista, Fabiani de Morais Batista, Miriam de Jesus Costa, Mariana Garcia Croda, Lais Alves da Cruz, Roberta Carolina Pereira Diogo, Rodrigo Cezar Dutra Escobar, Iara Rodrigues Fernandes, Leticia Ramires Figueiredo, Leandro Galdino Cavalcanti Gonçalves, Sarita Lahdo, Joyce dos Santos Lencina, Guilherme Teodoro de Lima, Larissa Santos Matos, Bruna Tayara Leopoldina Meireles, Debora Quadros Moreira, Lilian Batista Silva Muranaka, Adriely de Oliveira, Karla Regina Warszawski de Oliveira, Matheus Vieira de Oliveira, Roberto Dias de Oliveira, Andrea Antonia Souza de Almeida dos Reis Pereira, Marco Puga, Caroliny Veron Ramos, Thaynara Haynara Souza da Rosa, Karla Lopes dos Santos, Claudinalva Ribeiro dos Santos, Dyenyffer Stéffany Leopoldina dos Santos, Karina Marques Santos, Paulo César Pereira da Silva, Paulo Victor Rocha da Silva, Débora dos Santos Silva, Patricia Vieira da Silva, Bruno Freitas da Rosa Soares, Mariana Gazzoni Sperotto, Mariana Mayumi Tadokoro, Daniel Tsuha, Hugo Miguel Ramos Vieira, Margareth Maria Pretti Dalcolmo, Cíntia Maria Lopes Alves da Paixão, Gabriela Corrêa E Castro, Simone Silva Collopy, Renato da Costa Silva, Samyra Almeida da Silveira, Alda Maria Da-Cruz, Alessandra Maria da Silva Passos de Carvalho, Rita de Cássia Batista, Maria Luciana Silva De Freitas, Aline Gerhardt de Oliveira Ferreira, Ana Paula Conceição de Souza, Paola Cerbino Doblas, Ayla Alcoforado da Silva dos Santos, Vanessa Cristine de Moraes dos Santos, Dayane Alves dos Santos Gomes, Anderson Lage Fortunato, Adriano Gomes-Silva, Monique Pinto Gonçalves, Paulo Leandro Garcia Meireless Junior, Estela Martins da Costa Carvalho, Fernando do Couto Motta, Ligia Maria Olivo de Mendonça, Girlene dos Santos Pandine, Rosa Maria Plácido Pereira, Ivan Ramos Maia, Jorge Luiz da Rocha, João Victor Paiva Romano, Glauce dos Santos, Erica Fernandes da Silva, Marilda Agudo Mendonça Teixeira de Siqueira, Ágatha Cristinne Prudêncio Soares, Sandra Franch Arroyo, Henny Ophorst-den Besten, Anna Boon, Karin M. Brakke, Axel Janssen, Marijke A.H. Koopmans, Toos Lemmens, Titia Leurink, Engelien Septer-Bijleveld, Kimberly Stadhouders, Darren Troeman, Marije van der Waal, Marjoleine van Opdorp, Nicolette van Sluis, Beatrijs Wolters, Jan Kluytmans, Jannie Romme, Wouter van den Bijllaardt, Linda van Mook, M.M.L (Miranda) van Rijen, P.M.G. Filius, Jet Gisolf, Frances Greven, Danique Huijbens, Robert Jan Hassing, R.C. Pon, Lieke Preijers, J.H. van Leusen, Harald Verheij, Wim Boersma, Evelien Brans, Paul Kloeg, Kitty Molenaar-Groot, Nhat Khanh Nguyen, Nienke Paternotte, Anke Rol, Lida Stooper, Helga Dijkstra, Esther Eggenhuizen, Lucas Huijs, Simone Moorlag, Mihai Netea, Eva Pranger, Esther Taks, Jaap ten Oever, Rob ter Heine, Kitty Blauwendraat, Bob Meek, Isil Erkaya, Houda Harbech, Nienke Roescher, Rifka Peeters, Menno te Riele, Carmen Zhou, Esther Calbo, Cristina Badia Marti, Emma Triviño Palomares, Tomás Perez Porcuna, Anabel Barriocanal, Ana Maria Barriocanal, Irma Casas, Jose Dominguez, Maria Esteve, Alicia Lacoma, Irene Latorre, Gemma Molina, Barbara Molina, Antoni Rosell, Sandra Vidal, Lydia Barrera, Natalia Bustos, Ines Portillo Calderón, David Gutierrez Campos, Jose Manuel Carretero, Angel Dominguez Castellano, Renato Compagnone, Encarnacion Ramirez de Arellano, Almudena de la Serna, Maria Dolores del Toro Lopez, Marie-Alix Clement Espindola, Ana Belen Martin Gutierrez, Alvaro Pascual Hernandez, Virginia Palomo Jiménez, Elisa Moreno, Nicolas Navarrete, Teresa Rodriguez Paño, Jesús Rodríguez-Baño, Enriqueta Tristán, Maria Jose Rios Villegas, Atsegiñe Canga Garces, Erika Castro Amo, Raquel Coya Guerrero, Josune Goikoetxea, Leticia Jorge, Cristina Perez, María Carmen Fariñas Álvarez, Manuel Gutierrez Cuadra, Francisco Arnaiz de las Revillas Almajano, Pilar Bohedo Garcia, Teresa Giménez Poderos, Claudia González Rico, Blanca Sanchez, Olga Valero, Noelia Vega, Anna Barnes, Helen Catterick, Tim Cranston, Phoebe Dawe, Emily Fletcher, Liam Fouracre, Alison Gifford, John Kirkwood, Christopher Martin, Amy McAnew, Marcus Mitchell, Georgina Newman, Abby O'Connell, Jakob Onysk, Lynne Quinn, Shelley Rhodes, Samuel Stone, Lorrie Symons, Harry Tripp, Darcy Watkins, Bethany Whale, Alex Harding, Gemma Lockhart, Kate Sidaway-Lee, Sam Hilton, Sarah Manton, Daniel Webber-Rookes, Rachel Winder, James Moore, Freya Bateman, Michael Gibbons, Bridget Knight, Julie Moss, Sarah Statton, Josephine Studham, Lydia Hall, Will Moyle, Tamsin Venton
Format:	Article
Language:	English
Published:	Elsevier 2023-10-01
Series:	EClinicalMedicine
Subjects:	Herpes simplex virus Cold sore Herpes labialis Bacille Calmette-Guérin Mycobacterium bovis Prevention
Online Access:	http://www.sciencedirect.com/science/article/pii/S2589537023003802

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author	Laure F. Pittet Cecilia L. Moore Ellie McDonald Simone Barry Marc Bonten John Campbell Julio Croda Margareth Dalcolmo Andrew Davidson Mark W. Douglas Kaya Gardiner Amanda Gwee Bruno Jardim Marcus V.G. Lacerda Michaela Lucas David J. Lynn Laurens Manning Roberto D. de Oliveira Kirsten P. Perrett Cristina Prat-Aymerich Peter C. Richmond Jorge L. Rocha Jesus Rodriguez-Baño Adilia Warris Nicholas J. Wood Nicole L. Messina Nigel Curtis Nigel Curtis Andrew Davidson Kaya Gardiner Amanda Gwee Tenaya Jamieson Nicole Messina Thilanka Morawakage Susan Perlen Kirsten Perrett Laure Pittet Amber Sastry Jia Wei Teo Francesca Orsini Katherine Lee Cecilia Moore Suzanna Vidmar Laure Pittet Rashida Ali Ross Dunn Peta Edler Grace Gell Casey Goodall Richard Hall Ann Krastev Nathan La Ellie McDonald Nick McPhate Thao Nguyen Jack Ren Luke Stevens Nicole Messina Ahmed Alamrousi Rhian Bonnici Thanh Dang Susie Germano Jenny Hua Rebecca McElroy Monica Razmovska Scott Reddiex Xiaofang Wang Jeremy Anderson Kristy Azzopardi Vicki Bennett-Wood Anna Czajko Nadia Mazarakis Conor McCafferty Frances Oppedisano Belinda Ortika Casey Pell Leena Spry Ryan Toh Sunitha Velagapudi Amanda Vlahos Ashleigh Wee-Hee Pedro Ramos Karina De La Cruz Dinusha Gamage Anushka Karunanayake Isabella Mezzetti Benjamin Ong Ronita Singh Enoshini Sooriyarachchi Suellen Nicholson Natalie Cain Rianne Brizuela Han Huang Veronica Abruzzo Morgan Bealing Patricia Bimboese Kirsty Bowes Emma Burrell Joyce Chan Jac Cushnahan Hannah Elborough Olivia Elkington Kieran Fahey Monique Fernandez Catherine Flynn Sarah Fowler Marie Gentile Andrit Bojana Gladanac Catherine Hammond Norine Ma Sam Macalister Emmah Milojevic Jesutofunmi Mojeed Jill Nguyen Liz O'Donnell Nadia Olivier Isabelle Ooi Stephanie Reynolds Lisa Shen Barb Sherry Judith Spotswood Jamie Wedderburn Angela Younes Donna Legge Jason Bell Jo Cheah Annie Cobbledick Kee Lim Sonja Elia Lynne Addlem Anna Bourke Clare Brophy Nadine Henare Narelle Jenkins Francesca Machingaifa Skye Miller Kirsten Mitchell Sigrid Pitkin Kate Wall Paola Villanueva Nigel Crawford Laure Pittet Wendy Norton Niki Tan Thilakavathi Chengodu Diane Dawson Victoria Gordon Tony Korman Jess O'Bryan Veronica Abruzzo Sophie Agius Samantha Bannister Jess Bucholc Alison Burns Beatriz Camesella John Carlin Marianna Ciaverella Maxwell Curtis Stephanie Firth Christina Guo Matthew Hannan Erin Hill Sri Joshi Katherine Lieschke Megan Mathers Sasha Odoi Ashleigh Rak Chris Richards Leah Steve Carolyn Stewart Eva Sudbury Helen Thomson Emma Watts Fiona Williams Angela Young Penny Glenn Andrew Kaynes Amandine Philippart De Floy Sandy Buchanan Thijs Sondag Ivy Xie Harriet Edmund Bridie Byrne Tom Keeble Belle Ngien Fran Noonan Michelle Wearing-Smith Alison Clarke Pemma Davies Oliver Eastwood Alric Ellinghaus Rachid Ghieh Zahra Hilton Emma Jennings Athina Kakkos Iris Liang Katie Nicol Sally O'Callaghan Helen Osman Gowri Rajaram Sophia Ratcliffe Victoria Rayner Ashleigh Salmon Angela Scheppokat Aimee Stevens Rebekah Street Nicholas Toogood Nicholas Wood Twinkle Bahaduri Therese Baulman Jennifer Byrne Candace Carter Mary Corbett Aiken Dao Maria Desylva Andrew Dunn Evangeline Gardiner Rosemary Joyce Rama Kandasamy Craig Munns Lisa Pelayo Ketaki Sharma Katrina Sterling Caitlin Uren Clinton Colaco Mark Douglas Kate Hamilton Adam Bartlett Brendan McMullan Pamela Palasanthiran Phoebe Williams Justin Beardsley Nikki Bergant Renier Lagunday Kristen Overton Jeffrey Post Yasmeen Al-Hindawi Sarah Barney Anthony Byrne Lee Mead Marshall Plit David Lynn Saoirse Benson Stephen Blake Rochelle Botten Tee Yee Chern Georgina Eden Liddy Griffith Jane James Miriam Lynn Angela Markow Domenic Sacca Natalie Stevens Steve Wesselingh Catriona Doran Simone Barry Alice Sawka Sue Evans Louise Goodchild Christine Heath Meredith Krieg Helen Marshall Mark McMillan Mary Walker Peter Richmond Nelly Amenyogbe Christina Anthony Annabelle Arnold Beth Arrowsmith Rym Ben-Othman Sharon Clark Jemma Dunnill Nat Eiffler Krist Ewe Carolyn Finucane Lorraine Flynn Camille Gibson Lucy Hartnell Elysia Hollams Heidi Hutton Lance Jarvis Jane Jones Jan Jones Karen Jones Jennifer Kent Tobias Kollmann Debbie Lalich Wenna Lee Rachel Lim Sonia McAlister Fiona McDonald Andrea Meehan Asma Minhaj Lisa Montgomery Melissa O'Donnell Jaslyn Ong Joanne Ong Kimberley Parkin Glady Perez Catherine Power Shadie Rezazadeh Holly Richmond Sally Rogers Nikki Schultz Margaret Shave Patrycja Skut Lisa Stiglmayer Alexandra Truelove Ushma Wadia Rachael Wallace Justin Waring Michelle England Erin Latkovic Laurens Manning Susan Herrmann Michaela Lucas Marcus Lacerda Paulo Henrique Andrade Fabiane Bianca Barbosa Dayanne Barros Larissa Brasil Ana Greyce Capella Ramon Castro Erlane Costa Dilcimar de Souza Maianne Dias José Dias Klenilson Ferreira Paula Figueiredo Thamires Freitas Ana Carolina Furtado Larissa Gama Vanessa Godinho Cintia Gouy Daniele Hinojosa Bruno Jardim Tyane Jardim Joel Junior Augustto Lima Bernardo Maia Adriana Marins Kelry Mazurega Tercilene Medeiros Rosangela Melo Marinete Moraes Elizandra Nascimento Juliana Neves Maria Gabriela Oliveira Thais Oliveira Ingrid Oliveira Arthur Otsuka Rayssa Paes Handerson Pereira Gabrielle Pereira Christiane Prado Evelyn Queiroz Laleyska Rodrigues Bebeto Rodrigues Vanderson Sampaio Anna Gabriela Santos Daniel Santos Tilza Santos Evelyn Santos Ariandra Sartim Ana Beatriz Silva Juliana Silva Emanuelle Silva Mariana Simão Caroline Soares Antonny Sousa Alexandre Trindade Fernando Val Adria Vasconcelos Heline Vasconcelos Julio Croda Carolinne Abreu Katya Martinez Almeida Camila Bitencourt de Andrade Jhenyfer Thalyta Campos Angelo Ghislaine Gonçalvez de Araújo Arcanjo Bianca Maria Silva Menezes Arruda Wellyngthon Espindola Ayala Adelita Agripina Refosco Barbosa Felipe Zampieri Vieira Batista Fabiani de Morais Batista Miriam de Jesus Costa Mariana Garcia Croda Lais Alves da Cruz Roberta Carolina Pereira Diogo Rodrigo Cezar Dutra Escobar Iara Rodrigues Fernandes Leticia Ramires Figueiredo Leandro Galdino Cavalcanti Gonçalves Sarita Lahdo Joyce dos Santos Lencina Guilherme Teodoro de Lima Larissa Santos Matos Bruna Tayara Leopoldina Meireles Debora Quadros Moreira Lilian Batista Silva Muranaka Adriely de Oliveira Karla Regina Warszawski de Oliveira Matheus Vieira de Oliveira Roberto Dias de Oliveira Andrea Antonia Souza de Almeida dos Reis Pereira Marco Puga Caroliny Veron Ramos Thaynara Haynara Souza da Rosa Karla Lopes dos Santos Claudinalva Ribeiro dos Santos Dyenyffer Stéffany Leopoldina dos Santos Karina Marques Santos Paulo César Pereira da Silva Paulo Victor Rocha da Silva Débora dos Santos Silva Patricia Vieira da Silva Bruno Freitas da Rosa Soares Mariana Gazzoni Sperotto Mariana Mayumi Tadokoro Daniel Tsuha Hugo Miguel Ramos Vieira Margareth Maria Pretti Dalcolmo Cíntia Maria Lopes Alves da Paixão Gabriela Corrêa E Castro Simone Silva Collopy Renato da Costa Silva Samyra Almeida da Silveira Alda Maria Da-Cruz Alessandra Maria da Silva Passos de Carvalho Rita de Cássia Batista Maria Luciana Silva De Freitas Aline Gerhardt de Oliveira Ferreira Ana Paula Conceição de Souza Paola Cerbino Doblas Ayla Alcoforado da Silva dos Santos Vanessa Cristine de Moraes dos Santos Dayane Alves dos Santos Gomes Anderson Lage Fortunato Adriano Gomes-Silva Monique Pinto Gonçalves Paulo Leandro Garcia Meireless Junior Estela Martins da Costa Carvalho Fernando do Couto Motta Ligia Maria Olivo de Mendonça Girlene dos Santos Pandine Rosa Maria Plácido Pereira Ivan Ramos Maia Jorge Luiz da Rocha João Victor Paiva Romano Glauce dos Santos Erica Fernandes da Silva Marilda Agudo Mendonça Teixeira de Siqueira Ágatha Cristinne Prudêncio Soares Marc Bonten Sandra Franch Arroyo Henny Ophorst-den Besten Anna Boon Karin M. Brakke Axel Janssen Marijke A.H. Koopmans Toos Lemmens Titia Leurink Cristina Prat-Aymerich Engelien Septer-Bijleveld Kimberly Stadhouders Darren Troeman Marije van der Waal Marjoleine van Opdorp Nicolette van Sluis Beatrijs Wolters Jan Kluytmans Jannie Romme Wouter van den Bijllaardt Linda van Mook M.M.L (Miranda) van Rijen P.M.G. Filius Jet Gisolf Frances Greven Danique Huijbens Robert Jan Hassing R.C. Pon Lieke Preijers J.H. van Leusen Harald Verheij Wim Boersma Evelien Brans Paul Kloeg Kitty Molenaar-Groot Nhat Khanh Nguyen Nienke Paternotte Anke Rol Lida Stooper Helga Dijkstra Esther Eggenhuizen Lucas Huijs Simone Moorlag Mihai Netea Eva Pranger Esther Taks Jaap ten Oever Rob ter Heine Kitty Blauwendraat Bob Meek Isil Erkaya Houda Harbech Nienke Roescher Rifka Peeters Menno te Riele Carmen Zhou Esther Calbo Cristina Badia Marti Emma Triviño Palomares Tomás Perez Porcuna Anabel Barriocanal Ana Maria Barriocanal Irma Casas Jose Dominguez Maria Esteve Alicia Lacoma Irene Latorre Gemma Molina Barbara Molina Antoni Rosell Sandra Vidal Lydia Barrera Natalia Bustos Ines Portillo Calderón David Gutierrez Campos Jose Manuel Carretero Angel Dominguez Castellano Renato Compagnone Encarnacion Ramirez de Arellano Almudena de la Serna Maria Dolores del Toro Lopez Marie-Alix Clement Espindola Ana Belen Martin Gutierrez Alvaro Pascual Hernandez Virginia Palomo Jiménez Elisa Moreno Nicolas Navarrete Teresa Rodriguez Paño Jesús Rodríguez-Baño Enriqueta Tristán Maria Jose Rios Villegas Atsegiñe Canga Garces Erika Castro Amo Raquel Coya Guerrero Josune Goikoetxea Leticia Jorge Cristina Perez María Carmen Fariñas Álvarez Manuel Gutierrez Cuadra Francisco Arnaiz de las Revillas Almajano Pilar Bohedo Garcia Teresa Giménez Poderos Claudia González Rico Blanca Sanchez Olga Valero Noelia Vega John Campbell Anna Barnes Helen Catterick Tim Cranston Phoebe Dawe Emily Fletcher Liam Fouracre Alison Gifford John Kirkwood Christopher Martin Amy McAnew Marcus Mitchell Georgina Newman Abby O'Connell Jakob Onysk Lynne Quinn Shelley Rhodes Samuel Stone Lorrie Symons Harry Tripp Adilia Warris Darcy Watkins Bethany Whale Alex Harding Gemma Lockhart Kate Sidaway-Lee John Campbell Sam Hilton Sarah Manton Daniel Webber-Rookes Rachel Winder James Moore Freya Bateman Michael Gibbons Bridget Knight Julie Moss Sarah Statton Josephine Studham Lydia Hall Will Moyle Tamsin Venton
author_facet	Laure F. Pittet Cecilia L. Moore Ellie McDonald Simone Barry Marc Bonten John Campbell Julio Croda Margareth Dalcolmo Andrew Davidson Mark W. Douglas Kaya Gardiner Amanda Gwee Bruno Jardim Marcus V.G. Lacerda Michaela Lucas David J. Lynn Laurens Manning Roberto D. de Oliveira Kirsten P. Perrett Cristina Prat-Aymerich Peter C. Richmond Jorge L. Rocha Jesus Rodriguez-Baño Adilia Warris Nicholas J. Wood Nicole L. Messina Nigel Curtis Nigel Curtis Andrew Davidson Kaya Gardiner Amanda Gwee Tenaya Jamieson Nicole Messina Thilanka Morawakage Susan Perlen Kirsten Perrett Laure Pittet Amber Sastry Jia Wei Teo Francesca Orsini Katherine Lee Cecilia Moore Suzanna Vidmar Laure Pittet Rashida Ali Ross Dunn Peta Edler Grace Gell Casey Goodall Richard Hall Ann Krastev Nathan La Ellie McDonald Nick McPhate Thao Nguyen Jack Ren Luke Stevens Nicole Messina Ahmed Alamrousi Rhian Bonnici Thanh Dang Susie Germano Jenny Hua Rebecca McElroy Monica Razmovska Scott Reddiex Xiaofang Wang Jeremy Anderson Kristy Azzopardi Vicki Bennett-Wood Anna Czajko Nadia Mazarakis Conor McCafferty Frances Oppedisano Belinda Ortika Casey Pell Leena Spry Ryan Toh Sunitha Velagapudi Amanda Vlahos Ashleigh Wee-Hee Pedro Ramos Karina De La Cruz Dinusha Gamage Anushka Karunanayake Isabella Mezzetti Benjamin Ong Ronita Singh Enoshini Sooriyarachchi Suellen Nicholson Natalie Cain Rianne Brizuela Han Huang Veronica Abruzzo Morgan Bealing Patricia Bimboese Kirsty Bowes Emma Burrell Joyce Chan Jac Cushnahan Hannah Elborough Olivia Elkington Kieran Fahey Monique Fernandez Catherine Flynn Sarah Fowler Marie Gentile Andrit Bojana Gladanac Catherine Hammond Norine Ma Sam Macalister Emmah Milojevic Jesutofunmi Mojeed Jill Nguyen Liz O'Donnell Nadia Olivier Isabelle Ooi Stephanie Reynolds Lisa Shen Barb Sherry Judith Spotswood Jamie Wedderburn Angela Younes Donna Legge Jason Bell Jo Cheah Annie Cobbledick Kee Lim Sonja Elia Lynne Addlem Anna Bourke Clare Brophy Nadine Henare Narelle Jenkins Francesca Machingaifa Skye Miller Kirsten Mitchell Sigrid Pitkin Kate Wall Paola Villanueva Nigel Crawford Laure Pittet Wendy Norton Niki Tan Thilakavathi Chengodu Diane Dawson Victoria Gordon Tony Korman Jess O'Bryan Veronica Abruzzo Sophie Agius Samantha Bannister Jess Bucholc Alison Burns Beatriz Camesella John Carlin Marianna Ciaverella Maxwell Curtis Stephanie Firth Christina Guo Matthew Hannan Erin Hill Sri Joshi Katherine Lieschke Megan Mathers Sasha Odoi Ashleigh Rak Chris Richards Leah Steve Carolyn Stewart Eva Sudbury Helen Thomson Emma Watts Fiona Williams Angela Young Penny Glenn Andrew Kaynes Amandine Philippart De Floy Sandy Buchanan Thijs Sondag Ivy Xie Harriet Edmund Bridie Byrne Tom Keeble Belle Ngien Fran Noonan Michelle Wearing-Smith Alison Clarke Pemma Davies Oliver Eastwood Alric Ellinghaus Rachid Ghieh Zahra Hilton Emma Jennings Athina Kakkos Iris Liang Katie Nicol Sally O'Callaghan Helen Osman Gowri Rajaram Sophia Ratcliffe Victoria Rayner Ashleigh Salmon Angela Scheppokat Aimee Stevens Rebekah Street Nicholas Toogood Nicholas Wood Twinkle Bahaduri Therese Baulman Jennifer Byrne Candace Carter Mary Corbett Aiken Dao Maria Desylva Andrew Dunn Evangeline Gardiner Rosemary Joyce Rama Kandasamy Craig Munns Lisa Pelayo Ketaki Sharma Katrina Sterling Caitlin Uren Clinton Colaco Mark Douglas Kate Hamilton Adam Bartlett Brendan McMullan Pamela Palasanthiran Phoebe Williams Justin Beardsley Nikki Bergant Renier Lagunday Kristen Overton Jeffrey Post Yasmeen Al-Hindawi Sarah Barney Anthony Byrne Lee Mead Marshall Plit David Lynn Saoirse Benson Stephen Blake Rochelle Botten Tee Yee Chern Georgina Eden Liddy Griffith Jane James Miriam Lynn Angela Markow Domenic Sacca Natalie Stevens Steve Wesselingh Catriona Doran Simone Barry Alice Sawka Sue Evans Louise Goodchild Christine Heath Meredith Krieg Helen Marshall Mark McMillan Mary Walker Peter Richmond Nelly Amenyogbe Christina Anthony Annabelle Arnold Beth Arrowsmith Rym Ben-Othman Sharon Clark Jemma Dunnill Nat Eiffler Krist Ewe Carolyn Finucane Lorraine Flynn Camille Gibson Lucy Hartnell Elysia Hollams Heidi Hutton Lance Jarvis Jane Jones Jan Jones Karen Jones Jennifer Kent Tobias Kollmann Debbie Lalich Wenna Lee Rachel Lim Sonia McAlister Fiona McDonald Andrea Meehan Asma Minhaj Lisa Montgomery Melissa O'Donnell Jaslyn Ong Joanne Ong Kimberley Parkin Glady Perez Catherine Power Shadie Rezazadeh Holly Richmond Sally Rogers Nikki Schultz Margaret Shave Patrycja Skut Lisa Stiglmayer Alexandra Truelove Ushma Wadia Rachael Wallace Justin Waring Michelle England Erin Latkovic Laurens Manning Susan Herrmann Michaela Lucas Marcus Lacerda Paulo Henrique Andrade Fabiane Bianca Barbosa Dayanne Barros Larissa Brasil Ana Greyce Capella Ramon Castro Erlane Costa Dilcimar de Souza Maianne Dias José Dias Klenilson Ferreira Paula Figueiredo Thamires Freitas Ana Carolina Furtado Larissa Gama Vanessa Godinho Cintia Gouy Daniele Hinojosa Bruno Jardim Tyane Jardim Joel Junior Augustto Lima Bernardo Maia Adriana Marins Kelry Mazurega Tercilene Medeiros Rosangela Melo Marinete Moraes Elizandra Nascimento Juliana Neves Maria Gabriela Oliveira Thais Oliveira Ingrid Oliveira Arthur Otsuka Rayssa Paes Handerson Pereira Gabrielle Pereira Christiane Prado Evelyn Queiroz Laleyska Rodrigues Bebeto Rodrigues Vanderson Sampaio Anna Gabriela Santos Daniel Santos Tilza Santos Evelyn Santos Ariandra Sartim Ana Beatriz Silva Juliana Silva Emanuelle Silva Mariana Simão Caroline Soares Antonny Sousa Alexandre Trindade Fernando Val Adria Vasconcelos Heline Vasconcelos Julio Croda Carolinne Abreu Katya Martinez Almeida Camila Bitencourt de Andrade Jhenyfer Thalyta Campos Angelo Ghislaine Gonçalvez de Araújo Arcanjo Bianca Maria Silva Menezes Arruda Wellyngthon Espindola Ayala Adelita Agripina Refosco Barbosa Felipe Zampieri Vieira Batista Fabiani de Morais Batista Miriam de Jesus Costa Mariana Garcia Croda Lais Alves da Cruz Roberta Carolina Pereira Diogo Rodrigo Cezar Dutra Escobar Iara Rodrigues Fernandes Leticia Ramires Figueiredo Leandro Galdino Cavalcanti Gonçalves Sarita Lahdo Joyce dos Santos Lencina Guilherme Teodoro de Lima Larissa Santos Matos Bruna Tayara Leopoldina Meireles Debora Quadros Moreira Lilian Batista Silva Muranaka Adriely de Oliveira Karla Regina Warszawski de Oliveira Matheus Vieira de Oliveira Roberto Dias de Oliveira Andrea Antonia Souza de Almeida dos Reis Pereira Marco Puga Caroliny Veron Ramos Thaynara Haynara Souza da Rosa Karla Lopes dos Santos Claudinalva Ribeiro dos Santos Dyenyffer Stéffany Leopoldina dos Santos Karina Marques Santos Paulo César Pereira da Silva Paulo Victor Rocha da Silva Débora dos Santos Silva Patricia Vieira da Silva Bruno Freitas da Rosa Soares Mariana Gazzoni Sperotto Mariana Mayumi Tadokoro Daniel Tsuha Hugo Miguel Ramos Vieira Margareth Maria Pretti Dalcolmo Cíntia Maria Lopes Alves da Paixão Gabriela Corrêa E Castro Simone Silva Collopy Renato da Costa Silva Samyra Almeida da Silveira Alda Maria Da-Cruz Alessandra Maria da Silva Passos de Carvalho Rita de Cássia Batista Maria Luciana Silva De Freitas Aline Gerhardt de Oliveira Ferreira Ana Paula Conceição de Souza Paola Cerbino Doblas Ayla Alcoforado da Silva dos Santos Vanessa Cristine de Moraes dos Santos Dayane Alves dos Santos Gomes Anderson Lage Fortunato Adriano Gomes-Silva Monique Pinto Gonçalves Paulo Leandro Garcia Meireless Junior Estela Martins da Costa Carvalho Fernando do Couto Motta Ligia Maria Olivo de Mendonça Girlene dos Santos Pandine Rosa Maria Plácido Pereira Ivan Ramos Maia Jorge Luiz da Rocha João Victor Paiva Romano Glauce dos Santos Erica Fernandes da Silva Marilda Agudo Mendonça Teixeira de Siqueira Ágatha Cristinne Prudêncio Soares Marc Bonten Sandra Franch Arroyo Henny Ophorst-den Besten Anna Boon Karin M. Brakke Axel Janssen Marijke A.H. Koopmans Toos Lemmens Titia Leurink Cristina Prat-Aymerich Engelien Septer-Bijleveld Kimberly Stadhouders Darren Troeman Marije van der Waal Marjoleine van Opdorp Nicolette van Sluis Beatrijs Wolters Jan Kluytmans Jannie Romme Wouter van den Bijllaardt Linda van Mook M.M.L (Miranda) van Rijen P.M.G. Filius Jet Gisolf Frances Greven Danique Huijbens Robert Jan Hassing R.C. Pon Lieke Preijers J.H. van Leusen Harald Verheij Wim Boersma Evelien Brans Paul Kloeg Kitty Molenaar-Groot Nhat Khanh Nguyen Nienke Paternotte Anke Rol Lida Stooper Helga Dijkstra Esther Eggenhuizen Lucas Huijs Simone Moorlag Mihai Netea Eva Pranger Esther Taks Jaap ten Oever Rob ter Heine Kitty Blauwendraat Bob Meek Isil Erkaya Houda Harbech Nienke Roescher Rifka Peeters Menno te Riele Carmen Zhou Esther Calbo Cristina Badia Marti Emma Triviño Palomares Tomás Perez Porcuna Anabel Barriocanal Ana Maria Barriocanal Irma Casas Jose Dominguez Maria Esteve Alicia Lacoma Irene Latorre Gemma Molina Barbara Molina Antoni Rosell Sandra Vidal Lydia Barrera Natalia Bustos Ines Portillo Calderón David Gutierrez Campos Jose Manuel Carretero Angel Dominguez Castellano Renato Compagnone Encarnacion Ramirez de Arellano Almudena de la Serna Maria Dolores del Toro Lopez Marie-Alix Clement Espindola Ana Belen Martin Gutierrez Alvaro Pascual Hernandez Virginia Palomo Jiménez Elisa Moreno Nicolas Navarrete Teresa Rodriguez Paño Jesús Rodríguez-Baño Enriqueta Tristán Maria Jose Rios Villegas Atsegiñe Canga Garces Erika Castro Amo Raquel Coya Guerrero Josune Goikoetxea Leticia Jorge Cristina Perez María Carmen Fariñas Álvarez Manuel Gutierrez Cuadra Francisco Arnaiz de las Revillas Almajano Pilar Bohedo Garcia Teresa Giménez Poderos Claudia González Rico Blanca Sanchez Olga Valero Noelia Vega John Campbell Anna Barnes Helen Catterick Tim Cranston Phoebe Dawe Emily Fletcher Liam Fouracre Alison Gifford John Kirkwood Christopher Martin Amy McAnew Marcus Mitchell Georgina Newman Abby O'Connell Jakob Onysk Lynne Quinn Shelley Rhodes Samuel Stone Lorrie Symons Harry Tripp Adilia Warris Darcy Watkins Bethany Whale Alex Harding Gemma Lockhart Kate Sidaway-Lee John Campbell Sam Hilton Sarah Manton Daniel Webber-Rookes Rachel Winder James Moore Freya Bateman Michael Gibbons Bridget Knight Julie Moss Sarah Statton Josephine Studham Lydia Hall Will Moyle Tamsin Venton
author_sort	Laure F. Pittet
collection	DOAJ
description	Summary: Background: Recurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects. Methods: In this nested randomised controlled trial within the multicentre, phase 3 BRACE trial, 6828 healthcare workers were randomised in 36 sites in Australia, the Netherlands, Spain, the United Kingdom and Brazil, to receive BCG-Denmark or no BCG (1:1 ratio using a web-based procedure) and followed for 12 months with 3-monthly questionnaires. Exclusion criteria included contraindication to BCG vaccine or previous vaccination with BCG within the past year, any other live-attenuated vaccine within the last month, or any COVID-specific vaccine. The intervention group received one intradermal dose of 0.1 mL of BCG-Denmark corresponding to 2−8 x 105 colony forming units of Mycobacterium bovis, Danish strain 1331. The primary outcome was the difference in restricted mean survival time (i.e., time to first cold-sore recurrence), in participants with frequent recurrent herpes labialis (≥4 recurrences/year), analysed by intention-to-treat. Secondary outcomes addressed additional questions, including analyses in other sub-populations. Adverse events were monitored closely during the first 3 months and were reported in all participants who received one dose of study drug according to intervention received. The BRACE trial is registered with ClinicalTrials.gov, NCT04327206. Findings: Between March 30, 2020 and February 18, 2021, 84 individuals with frequent recurrent cold sores were randomly assigned to BCG (n = 38) or control (n = 46). The average time to first cold-sore recurrence was 1.55 months longer in the BCG group (95% CI 0.27–2.82, p = 0.02) than the control group (hazard ratio 0.54, 95% CI 0.32–0.91; intention-to-treat). The beneficial effect of BCG was greater in the as-treated population (difference 1.91 months, 95% CI 0.69–3.12, p = 0.003; hazard ratio 0.45, 95% CI 0.26–0.76). In prespecified subgroup analyses, only sex modified the treatment effect (interaction p = 0.007), with benefit restricted to males. Over 12 months, a greater proportion of participants in the BCG group compared with the control group reported a decrease in duration (61% vs 21%), severity (74% vs 21%), frequency (55% vs 21%), and impact on quality of life (42% vs 15%) of cold sore recurrences. In participants who had ever had a cold sore, there was also a decrease in self-reported burden of recurrences in the BCG group. In participants who had never had a cold sore, there was an increased risk of a first episode in the BCG group (risk difference 1.4%; 95% CI 0.3–2.6%, p = 0.02). There were no safety concerns. Interpretation: BCG-Denmark vaccination had a beneficial effect on herpes labialis, particularly in males with frequent recurrences, but may increase the risk of a first cold sore. Funding: Bill & Melinda Gates Foundation, the Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare, and individual donors.
first_indexed	2024-03-12T01:21:36Z
format	Article
id	doaj.art-896389b1c1db439ea00e6df21a06d395
institution	Directory Open Access Journal
issn	2589-5370
language	English
last_indexed	2024-03-12T01:21:36Z
publishDate	2023-10-01
publisher	Elsevier
record_format	Article
series	EClinicalMedicine
spelling	doaj.art-896389b1c1db439ea00e6df21a06d3952023-09-13T04:25:28ZengElsevierEClinicalMedicine2589-53702023-10-0164102203Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in contextLaure F. Pittet0Cecilia L. Moore1Ellie McDonald2Simone Barry3Marc Bonten4John Campbell5Julio Croda6Margareth Dalcolmo7Andrew Davidson8Mark W. Douglas9Kaya Gardiner10Amanda Gwee11Bruno Jardim12Marcus V.G. Lacerda13Michaela Lucas14David J. Lynn15Laurens Manning16Roberto D. de Oliveira17Kirsten P. Perrett18Cristina Prat-Aymerich19Peter C. Richmond20Jorge L. Rocha21Jesus Rodriguez-Baño22Adilia Warris23Nicholas J. Wood24Nicole L. Messina25Nigel Curtis26Nigel CurtisAndrew DavidsonKaya GardinerAmanda GweeTenaya JamiesonNicole MessinaThilanka MorawakageSusan PerlenKirsten PerrettLaure PittetAmber SastryJia Wei TeoFrancesca OrsiniKatherine LeeCecilia MooreSuzanna VidmarLaure PittetRashida AliRoss DunnPeta EdlerGrace GellCasey GoodallRichard HallAnn KrastevNathan LaEllie McDonaldNick McPhateThao NguyenJack RenLuke StevensNicole MessinaAhmed AlamrousiRhian BonniciThanh DangSusie GermanoJenny HuaRebecca McElroyMonica RazmovskaScott ReddiexXiaofang WangJeremy AndersonKristy AzzopardiVicki Bennett-WoodAnna CzajkoNadia MazarakisConor McCaffertyFrances OppedisanoBelinda OrtikaCasey PellLeena SpryRyan TohSunitha VelagapudiAmanda VlahosAshleigh Wee-HeePedro RamosKarina De La CruzDinusha GamageAnushka KarunanayakeIsabella MezzettiBenjamin OngRonita SinghEnoshini SooriyarachchiSuellen NicholsonNatalie CainRianne BrizuelaHan HuangVeronica AbruzzoMorgan BealingPatricia BimboeseKirsty BowesEmma BurrellJoyce ChanJac CushnahanHannah ElboroughOlivia ElkingtonKieran FaheyMonique FernandezCatherine FlynnSarah FowlerMarie Gentile AndritBojana GladanacCatherine HammondNorine MaSam MacalisterEmmah MilojevicJesutofunmi MojeedJill NguyenLiz O'DonnellNadia OlivierIsabelle OoiStephanie ReynoldsLisa ShenBarb SherryJudith SpotswoodJamie WedderburnAngela YounesDonna LeggeJason BellJo CheahAnnie CobbledickKee LimSonja EliaLynne AddlemAnna BourkeClare BrophyNadine HenareNarelle JenkinsFrancesca MachingaifaSkye MillerKirsten MitchellSigrid PitkinKate WallPaola VillanuevaNigel CrawfordLaure PittetWendy NortonNiki TanThilakavathi ChengoduDiane DawsonVictoria GordonTony KormanJess O'BryanVeronica AbruzzoSophie AgiusSamantha BannisterJess BucholcAlison BurnsBeatriz CamesellaJohn CarlinMarianna CiaverellaMaxwell CurtisStephanie FirthChristina GuoMatthew HannanErin HillSri JoshiKatherine LieschkeMegan MathersSasha OdoiAshleigh RakChris RichardsLeah SteveCarolyn StewartEva SudburyHelen ThomsonEmma WattsFiona WilliamsAngela YoungPenny GlennAndrew KaynesAmandine Philippart De FloySandy BuchananThijs SondagIvy XieHarriet EdmundBridie ByrneTom KeebleBelle NgienFran NoonanMichelle Wearing-SmithAlison ClarkePemma DaviesOliver EastwoodAlric EllinghausRachid GhiehZahra HiltonEmma JenningsAthina KakkosIris LiangKatie NicolSally O'CallaghanHelen OsmanGowri RajaramSophia RatcliffeVictoria RaynerAshleigh SalmonAngela ScheppokatAimee StevensRebekah StreetNicholas ToogoodNicholas WoodTwinkle BahaduriTherese BaulmanJennifer ByrneCandace CarterMary CorbettAiken DaoMaria DesylvaAndrew DunnEvangeline GardinerRosemary JoyceRama KandasamyCraig MunnsLisa PelayoKetaki SharmaKatrina SterlingCaitlin UrenClinton ColacoMark DouglasKate HamiltonAdam BartlettBrendan McMullanPamela PalasanthiranPhoebe WilliamsJustin BeardsleyNikki BergantRenier LagundayKristen OvertonJeffrey PostYasmeen Al-HindawiSarah BarneyAnthony ByrneLee MeadMarshall PlitDavid LynnSaoirse BensonStephen BlakeRochelle BottenTee Yee ChernGeorgina EdenLiddy GriffithJane JamesMiriam LynnAngela MarkowDomenic SaccaNatalie StevensSteve WesselinghCatriona DoranSimone BarryAlice SawkaSue EvansLouise GoodchildChristine HeathMeredith KriegHelen MarshallMark McMillanMary WalkerPeter RichmondNelly AmenyogbeChristina AnthonyAnnabelle ArnoldBeth ArrowsmithRym Ben-OthmanSharon ClarkJemma DunnillNat EifflerKrist EweCarolyn FinucaneLorraine FlynnCamille GibsonLucy HartnellElysia HollamsHeidi HuttonLance JarvisJane JonesJan JonesKaren JonesJennifer KentTobias KollmannDebbie LalichWenna LeeRachel LimSonia McAlisterFiona McDonaldAndrea MeehanAsma MinhajLisa MontgomeryMelissa O'DonnellJaslyn OngJoanne OngKimberley ParkinGlady PerezCatherine PowerShadie RezazadehHolly RichmondSally RogersNikki SchultzMargaret ShavePatrycja SkutLisa StiglmayerAlexandra TrueloveUshma WadiaRachael WallaceJustin WaringMichelle EnglandErin LatkovicLaurens ManningSusan HerrmannMichaela LucasMarcus LacerdaPaulo Henrique AndradeFabiane Bianca BarbosaDayanne BarrosLarissa BrasilAna Greyce CapellaRamon CastroErlane CostaDilcimar de SouzaMaianne DiasJosé DiasKlenilson FerreiraPaula FigueiredoThamires FreitasAna Carolina FurtadoLarissa GamaVanessa GodinhoCintia GouyDaniele HinojosaBruno JardimTyane JardimJoel JuniorAugustto LimaBernardo MaiaAdriana MarinsKelry MazuregaTercilene MedeirosRosangela MeloMarinete MoraesElizandra NascimentoJuliana NevesMaria Gabriela OliveiraThais OliveiraIngrid OliveiraArthur OtsukaRayssa PaesHanderson PereiraGabrielle PereiraChristiane PradoEvelyn QueirozLaleyska RodriguesBebeto RodriguesVanderson SampaioAnna Gabriela SantosDaniel SantosTilza SantosEvelyn SantosAriandra SartimAna Beatriz SilvaJuliana SilvaEmanuelle SilvaMariana SimãoCaroline SoaresAntonny SousaAlexandre TrindadeFernando ValAdria VasconcelosHeline VasconcelosJulio CrodaCarolinne AbreuKatya Martinez AlmeidaCamila Bitencourt de AndradeJhenyfer Thalyta Campos AngeloGhislaine Gonçalvez de Araújo ArcanjoBianca Maria Silva Menezes ArrudaWellyngthon Espindola AyalaAdelita Agripina Refosco BarbosaFelipe Zampieri Vieira BatistaFabiani de Morais BatistaMiriam de Jesus CostaMariana Garcia CrodaLais Alves da CruzRoberta Carolina Pereira DiogoRodrigo Cezar Dutra EscobarIara Rodrigues FernandesLeticia Ramires FigueiredoLeandro Galdino Cavalcanti GonçalvesSarita LahdoJoyce dos Santos LencinaGuilherme Teodoro de LimaLarissa Santos MatosBruna Tayara Leopoldina MeirelesDebora Quadros MoreiraLilian Batista Silva MuranakaAdriely de OliveiraKarla Regina Warszawski de OliveiraMatheus Vieira de OliveiraRoberto Dias de OliveiraAndrea Antonia Souza de Almeida dos Reis PereiraMarco PugaCaroliny Veron RamosThaynara Haynara Souza da RosaKarla Lopes dos SantosClaudinalva Ribeiro dos SantosDyenyffer Stéffany Leopoldina dos SantosKarina Marques SantosPaulo César Pereira da SilvaPaulo Victor Rocha da SilvaDébora dos Santos SilvaPatricia Vieira da SilvaBruno Freitas da Rosa SoaresMariana Gazzoni SperottoMariana Mayumi TadokoroDaniel TsuhaHugo Miguel Ramos VieiraMargareth Maria Pretti DalcolmoCíntia Maria Lopes Alves da PaixãoGabriela Corrêa E CastroSimone Silva CollopyRenato da Costa SilvaSamyra Almeida da SilveiraAlda Maria Da-CruzAlessandra Maria da Silva Passos de CarvalhoRita de Cássia BatistaMaria Luciana Silva De FreitasAline Gerhardt de Oliveira FerreiraAna Paula Conceição de SouzaPaola Cerbino DoblasAyla Alcoforado da Silva dos SantosVanessa Cristine de Moraes dos SantosDayane Alves dos Santos GomesAnderson Lage FortunatoAdriano Gomes-SilvaMonique Pinto GonçalvesPaulo Leandro Garcia Meireless JuniorEstela Martins da Costa CarvalhoFernando do Couto MottaLigia Maria Olivo de MendonçaGirlene dos Santos PandineRosa Maria Plácido PereiraIvan Ramos MaiaJorge Luiz da RochaJoão Victor Paiva RomanoGlauce dos SantosErica Fernandes da SilvaMarilda Agudo Mendonça Teixeira de SiqueiraÁgatha Cristinne Prudêncio SoaresMarc BontenSandra Franch ArroyoHenny Ophorst-den BestenAnna BoonKarin M. BrakkeAxel JanssenMarijke A.H. KoopmansToos LemmensTitia LeurinkCristina Prat-AymerichEngelien Septer-BijleveldKimberly StadhoudersDarren TroemanMarije van der WaalMarjoleine van OpdorpNicolette van SluisBeatrijs WoltersJan KluytmansJannie RommeWouter van den BijllaardtLinda van MookM.M.L (Miranda) van RijenP.M.G. FiliusJet GisolfFrances GrevenDanique HuijbensRobert Jan HassingR.C. PonLieke PreijersJ.H. van LeusenHarald VerheijWim BoersmaEvelien BransPaul KloegKitty Molenaar-GrootNhat Khanh NguyenNienke PaternotteAnke RolLida StooperHelga DijkstraEsther EggenhuizenLucas HuijsSimone MoorlagMihai NeteaEva PrangerEsther TaksJaap ten OeverRob ter HeineKitty BlauwendraatBob MeekIsil ErkayaHouda HarbechNienke RoescherRifka PeetersMenno te RieleCarmen ZhouEsther CalboCristina Badia MartiEmma Triviño PalomaresTomás Perez PorcunaAnabel BarriocanalAna Maria BarriocanalIrma CasasJose DominguezMaria EsteveAlicia LacomaIrene LatorreGemma MolinaBarbara MolinaAntoni RosellSandra VidalLydia BarreraNatalia BustosInes Portillo CalderónDavid Gutierrez CamposJose Manuel CarreteroAngel Dominguez CastellanoRenato CompagnoneEncarnacion Ramirez de ArellanoAlmudena de la SernaMaria Dolores del Toro LopezMarie-Alix Clement EspindolaAna Belen Martin GutierrezAlvaro Pascual HernandezVirginia Palomo JiménezElisa MorenoNicolas NavarreteTeresa Rodriguez PañoJesús Rodríguez-BañoEnriqueta TristánMaria Jose Rios VillegasAtsegiñe Canga GarcesErika Castro AmoRaquel Coya GuerreroJosune GoikoetxeaLeticia JorgeCristina PerezMaría Carmen Fariñas ÁlvarezManuel Gutierrez CuadraFrancisco Arnaiz de las Revillas AlmajanoPilar Bohedo GarciaTeresa Giménez PoderosClaudia González RicoBlanca SanchezOlga ValeroNoelia VegaJohn CampbellAnna BarnesHelen CatterickTim CranstonPhoebe DaweEmily FletcherLiam FouracreAlison GiffordJohn KirkwoodChristopher MartinAmy McAnewMarcus MitchellGeorgina NewmanAbby O'ConnellJakob OnyskLynne QuinnShelley RhodesSamuel StoneLorrie SymonsHarry TrippAdilia WarrisDarcy WatkinsBethany WhaleAlex HardingGemma LockhartKate Sidaway-LeeJohn CampbellSam HiltonSarah MantonDaniel Webber-RookesRachel WinderJames MooreFreya BatemanMichael GibbonsBridget KnightJulie MossSarah StattonJosephine StudhamLydia HallWill MoyleTamsin VentonInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia; Immunology, Vaccinology, and Infectious Diseases Unit, Department of Paediatrics, Gynaecology and Obsterics, Faculty of Medicine, University of Geneva and University Hospitals of Geneva, Geneva, SwitzerlandDepartment of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Melbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, AustraliaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, AustraliaPrecision Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia; Department of Thoracic Medicine, Royal Adelaide Hospital, Adelaide, South Australia, AustraliaJulius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the NetherlandsExeter Collaboration for Academic Primary Care, University of Exeter Medical School, Exeter, United KingdomFiocruz Mato Grosso do Sul, Fundação Oswaldo Cruz, Campo Grande, Brazil; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA; Universidade Federal de Mato Grosso do Sul, Campo Grande, BrazilHelio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Curicica, Brazil; Catholic University, Rio de Janeiro, BrazilMelbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, AustraliaStorr Liver Centre, The Westmead Institute for Medical Research, The University of Sydney, Westmead, New South Wales, Australia; Centre for Infectious Diseases and Microbiology, Sydney Infectious Diseases Institute, The University of Sydney at Westmead Hospital, Westmead, New South Wales, AustraliaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Research Operations, The Royal Children's Hospital Melbourne, Parkville, Victoria, AustraliaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, Victoria, AustraliaInstitute of Clinical Research Carlos Borborema, Doctor Heitor Vieira Dourado Tropical Medicine Foundation, Manaus, BrazilInstitute of Clinical Research Carlos Borborema, Doctor Heitor Vieira Dourado Tropical Medicine Foundation, Manaus, Brazil; Instituto Leônidas & Maria Deane, Oswaldo Cruz Foundation Ministry of Health, Manaus, Brazil; University of Texas Medical Branch, Galveston, TX, USADepartment of Immunology, Pathwest, Queen Elizabeth II Medical Centre, Nedlands, Western Australia, Australia; Department of Immunology, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia; Department of Immunology and General Paediatrics, Perth Children's Hospital, Nedlands, Western Australia, Australia; School of Medicine, University of Western Australia, Perth, Western Australia, AustraliaPrecision Medicine Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia; Flinders Health and Medical Research Institute, Flinders University, Bedford Park, South Australia, AustraliaSchool of Medicine, University of Western Australia, Perth, Western Australia, Australia; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia; Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, AustraliaNursing Course, State University of Mato Grosso do Sul, Dourados, Brazil; Graduate Program in Health Sciences, Federal University of Grande Dourados, Dourados, BrazilDepartment of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Melbourne Children's Trial Centre, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Allergy and Immunology, Royal Children's Hospital Melbourne, Parkville, Victoria, AustraliaJulius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht University, the Netherlands; Institut d'Investigació Germans Trias i Pujol, Departament de Genètica i Microbiologia, Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red (CIBER) de Enfermedades Respiratorias, Instituto de Salud Carlos III, Barcelona, SpainDepartment of Immunology and General Paediatrics, Perth Children's Hospital, Nedlands, Western Australia, Australia; School of Medicine, University of Western Australia, Perth, Western Australia, Australia; Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, AustraliaHelio Fraga Reference Center, Oswaldo Cruz Foundation Ministry of Health, Curicica, BrazilDivision of Infectious Diseases and Microbiology, Department of Medicine, Hospital Universitario Virgen Macarena, University of Seville, Biomedicines Institute of Seville-Consejo Superior de Investigaciones Científicas, Seville, Spain; CIBER de Enfermedades Infecciosas, Instituto de Salud Carloss III, Madrid, SpainMedical Research Council Centre for Medical Mycology, University of Exeter, Exeter, United KingdomFaculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia; Sydney Children's Hospital Network, Westmead, New South Wales, Australia; National Centre for Immunisation Research and Surveillance of Vaccine Preventable Disease, Westmead, New South Wales, AustraliaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, AustraliaInfectious Diseases Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia; Corresponding author. Department of Paediatrics, University of Melbourne, Royal Children's Hospital Melbourne, 50 Flemington Rd., Parkville, Victoria, 3052, Australia.Summary: Background: Recurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects. Methods: In this nested randomised controlled trial within the multicentre, phase 3 BRACE trial, 6828 healthcare workers were randomised in 36 sites in Australia, the Netherlands, Spain, the United Kingdom and Brazil, to receive BCG-Denmark or no BCG (1:1 ratio using a web-based procedure) and followed for 12 months with 3-monthly questionnaires. Exclusion criteria included contraindication to BCG vaccine or previous vaccination with BCG within the past year, any other live-attenuated vaccine within the last month, or any COVID-specific vaccine. The intervention group received one intradermal dose of 0.1 mL of BCG-Denmark corresponding to 2−8 x 105 colony forming units of Mycobacterium bovis, Danish strain 1331. The primary outcome was the difference in restricted mean survival time (i.e., time to first cold-sore recurrence), in participants with frequent recurrent herpes labialis (≥4 recurrences/year), analysed by intention-to-treat. Secondary outcomes addressed additional questions, including analyses in other sub-populations. Adverse events were monitored closely during the first 3 months and were reported in all participants who received one dose of study drug according to intervention received. The BRACE trial is registered with ClinicalTrials.gov, NCT04327206. Findings: Between March 30, 2020 and February 18, 2021, 84 individuals with frequent recurrent cold sores were randomly assigned to BCG (n = 38) or control (n = 46). The average time to first cold-sore recurrence was 1.55 months longer in the BCG group (95% CI 0.27–2.82, p = 0.02) than the control group (hazard ratio 0.54, 95% CI 0.32–0.91; intention-to-treat). The beneficial effect of BCG was greater in the as-treated population (difference 1.91 months, 95% CI 0.69–3.12, p = 0.003; hazard ratio 0.45, 95% CI 0.26–0.76). In prespecified subgroup analyses, only sex modified the treatment effect (interaction p = 0.007), with benefit restricted to males. Over 12 months, a greater proportion of participants in the BCG group compared with the control group reported a decrease in duration (61% vs 21%), severity (74% vs 21%), frequency (55% vs 21%), and impact on quality of life (42% vs 15%) of cold sore recurrences. In participants who had ever had a cold sore, there was also a decrease in self-reported burden of recurrences in the BCG group. In participants who had never had a cold sore, there was an increased risk of a first episode in the BCG group (risk difference 1.4%; 95% CI 0.3–2.6%, p = 0.02). There were no safety concerns. Interpretation: BCG-Denmark vaccination had a beneficial effect on herpes labialis, particularly in males with frequent recurrences, but may increase the risk of a first cold sore. Funding: Bill & Melinda Gates Foundation, the Minderoo Foundation, Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation, Health Services Union NSW, the Peter Sowerby Foundation, SA Health, the Insurance Advisernet Foundation, the NAB Foundation, the Calvert-Jones Foundation, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare, and individual donors.http://www.sciencedirect.com/science/article/pii/S2589537023003802Herpes simplex virusCold soreHerpes labialisBacille Calmette-GuérinMycobacterium bovisPrevention
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title	Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context
title_full	Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context
title_fullStr	Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context
title_full_unstemmed	Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context
title_short	Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context
title_sort	bacillus calmette guerin vaccination for protection against recurrent herpes labialis a nested randomised controlled trialresearch in context
topic	Herpes simplex virus Cold sore Herpes labialis Bacille Calmette-Guérin Mycobacterium bovis Prevention
url	http://www.sciencedirect.com/science/article/pii/S2589537023003802
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davidgutierrezcampos bacilluscalmetteguerinvaccinationforprotectionagainstrecurrentherpeslabialisanestedrandomisedcontrolledtrialresearchincontext AT josemanuelcarretero bacilluscalmetteguerinvaccinationforprotectionagainstrecurrentherpeslabialisanestedrandomisedcontrolledtrialresearchincontext AT angeldominguezcastellano bacilluscalmetteguerinvaccinationforprotectionagainstrecurrentherpeslabialisanestedrandomisedcontrolledtrialresearchincontext AT renatocompagnone bacilluscalmetteguerinvaccinationforprotectionagainstrecurrentherpeslabialisanestedrandomisedcontrolledtrialresearchincontext AT encarnacionramirezdearellano bacilluscalmetteguerinvaccinationforprotectionagainstrecurrentherpeslabialisanestedrandomisedcontrolledtrialresearchincontext AT almudenadelaserna bacilluscalmetteguerinvaccinationforprotectionagainstrecurrentherpeslabialisanestedrandomisedcontrolledtrialresearchincontext AT mariadoloresdeltorolopez 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