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1. Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trialResearch in context

Author

Laure F. Pittet, Nicole L. Messina, Ellie McDonald, Francesca Orsini, Simone Barry, Marc Bonten, John Campbell, Julio Croda, Mariana G. Croda, Margareth Dalcolmo, Kaya Gardiner, Amanda Gwee, Bruno Jardim, Marcus V.G. Lacerda, Michaela Lucas, David J. Lynn, Laurens Manning, Kirsten P. Perrett, Jeffrey J. Post, Cristina Prat-Aymerich, Peter C. Richmond, Jorge L. Rocha, Jesus Rodriguez-Baño, Adilia Warris, Nicholas J. Wood, Andrew Davidson, Nigel Curtis, Tenaya Jamieson, Nicole Messina, Thilanka Morawakage, Susan Perlen, Kirsten Perrett, Laure Pittet, Amber Sastry, Jia Wei Teo, 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, 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, Neil Gow, 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, and Tamsin Venton

Subjects
Bacille Calmette-Guérin (BCG) vaccine, Immunity, Heterologous, Health personnel, Randomised controlled trial, Primary prevention, Medicine (General), R5-920
Abstract

Summary: Background: Bacille Calmette-Guérin (BCG) vaccination has off-target (non-specific) effects that are associated with protection against unrelated infections and decreased all-cause mortality in infants. We aimed to determine whether BCG vaccination prevents febrile and respiratory infections in adults. Methods: This randomised controlled phase 3 trial was done in 36 healthcare centres in Australia, Brazil, the Netherlands, Spain, and the United Kingdom. Healthcare workers were randomised to receive BCG-Denmark (single 0.1 ml intradermal injection) or no BCG in a 1:1 ratio using a web-based procedure, stratified by stage, site, age, and presence of co-morbidity. The difference in occurrence of febrile or respiratory illness were measured over 12 months (prespecified secondary outcome) using the intention-to-treat (ITT) population. This trial is registered with ClinicalTrials.gov, NCT04327206. Findings: Between March 30, 2020, and April 1, 2021, 6828 healthcare workers were randomised to BCG-Denmark (n = 3417) or control (n = 3411; no intervention or placebo) groups. The 12-month adjusted estimated risk of ≥1 episode of febrile or respiratory illness was 66.8% in the BCG group (95% CI 65.3%–68.2%), compared with 63.4% in the control group (95% CI 61.8%–65.0%), a difference of +3.4 percentage points (95% CI +1.3% to +5.5%; p 0.002). The adjusted estimated risk of a severe episode (defined as being incapacitated for ≥3 consecutive days or hospitalised) was 19.4% in the BCG group (95% CI 18.0%–20.7%), compared with 18.8% in the control group (95% CI 17.4%–20.2%) a difference of +0.6 percentage points (95% CI −1.3% to +2.5%; p 0.6). Both groups had a similar number of episodes of illness, pneumonia, and hospitalisation. There were three deaths, all in the control group. There were no safety concerns following BCG vaccination. Interpretation: In contrast to the beneficial off-target effects reported following neonatal BCG in infants, a small increased risk of symptomatic febrile or respiratory illness was observed in the 12 months following BCG vaccination in adults. There was no evidence of a difference in the risk of severe disease. Funding: Bill & Melinda Gates Foundation, 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, the National Health and Medical Research Council, the Swiss National Science Foundation and individual donors.

Published
2024
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2. Specific and off-target immune responses following COVID-19 vaccination with ChAdOx1-S and BNT162b2 vaccines—an exploratory sub-study of the BRACE trialResearch in context

Author

Nicole L. Messina, Susie Germano, Rebecca McElroy, Rhian Bonnici, Branka Grubor-Bauk, David J. Lynn, Ellie McDonald, Suellen Nicholson, Kirsten P. Perrett, Laure F. Pittet, Rajeev Rudraraju, Natalie E. Stevens, Kanta Subbarao, 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, 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, Thanh Dang, Jenny Hua, 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, 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, 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, Margreet Filius, Jet Gisolf, Frances Greven, Danique Huijbens, Robert Jan Hassing, Roos Pon, Lieke Preijers, Joke 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, 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, and Tamsin Venton

Subjects
Vaccine, Off-target, Immunoregulation, Cytokine, SARS-CoV-2, Heterologous immunity, Medicine, Medicine (General), R5-920
Abstract

Summary: Background: The COVID-19 pandemic led to the rapid development and deployment of several highly effective vaccines against SARS-CoV-2. Recent studies suggest that these vaccines may also have off-target effects on the immune system. We sought to determine and compare the off-target effects of the adenovirus vector ChAdOx1-S (Oxford-AstraZeneca) and modified mRNA BNT162b2 (Pfizer-BioNTech) vaccines on immune responses to unrelated pathogens. Methods: Prospective sub-study within the BRACE trial. Blood samples were collected from 284 healthcare workers before and 28 days after ChAdOx1-S or BNT162b2 vaccination. SARS-CoV-2-specific antibodies were measured using ELISA, and whole blood cytokine responses to specific (SARS-CoV-2) and unrelated pathogen stimulation were measured by multiplex bead array. Findings: Both vaccines induced robust SARS-CoV-2 specific antibody and cytokine responses. ChAdOx1-S vaccination increased cytokine responses to heat-killed (HK) Candida albicans and HK Staphylococcus aureus and decreased cytokine responses to HK Escherichia coli and BCG. BNT162b2 vaccination decreased cytokine response to HK E. coli and had variable effects on cytokine responses to BCG and resiquimod (R848). After the second vaccine dose, BNT162b2 recipients had greater specific and off-target cytokine responses than ChAdOx1-S recipients. Interpretation: ChAdOx1-S and BNT162b2 vaccines alter cytokine responses to unrelated pathogens, indicative of potential off-target effects. The specific and off-target effects of these vaccines differ in their magnitude and breadth. The clinical relevance of these findings is uncertain and needs further study. Funding: Bill & Melinda Gates Foundation, National Health and Medical Research Council, Swiss National Science Foundation and the Melbourne Children’s. BRACE trial funding is detailed in acknowledgements.

Published
2024
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3. Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialResearch in context

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, 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, and Tamsin Venton

Subjects
Herpes simplex virus, Cold sore, Herpes labialis, Bacille Calmette-Guérin, Mycobacterium bovis, Prevention, Medicine (General), R5-920
Abstract

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.

Published
2023
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4. BNT162b2 COVID-19 vaccination in children alters cytokine responses to heterologous pathogens and Toll-like receptor agonists

Author

Andrés Noé, Thanh D. Dang, Christine Axelrad, Emma Burrell, Susie Germano, Sonja Elia, David Burgner, Kirsten P. Perrett, Nigel Curtis, and Nicole L. Messina

Subjects
SARS-CoV-2, heterologous, immunisation, paediatric vaccination, innate immunity, off-target effects, Immunologic diseases. Allergy, RC581-607
Abstract

BackgroundVaccines can have beneficial off-target (heterologous) effects that alter immune responses to, and protect against, unrelated infections. The heterologous effects of COVID-19 vaccines have not been investigated in children.AimTo investigate heterologous and specific immunological effects of BNT162b2 COVID-19 vaccination in children.MethodsA whole blood stimulation assay was used to investigate in vitro cytokine responses to heterologous stimulants (killed pathogens, Toll-like receptor ligands) and SARS-CoV-2 antigens. Samples from 29 children, aged 5-11 years, before and 28 days after a second BNT162b2 vaccination were analysed (V2 + 28). Samples from eight children were analysed six months after BNT162b2 vaccination.ResultsAt V2 + 28, interferon-γ and monocyte chemoattractant protein-1 responses to S. aureus, E. coli, L. monocytogenes, BCG vaccine, H. influenzae, hepatitis B antigen, poly(I:C) and R848 stimulations were decreased compared to pre-vaccination. For most of these heterologous stimulants, IL-6, IL-15 and IL-17 responses were also decreased. There were sustained decreases in cytokine responses to viral, but not bacterial, stimulants six months after BNT162b2 vaccination. Cytokine responses to irradiated SARS-CoV-2, and spike glycoprotein subunits (S1 and S2) were increased at V2 + 28 for most cytokines and remained higher than pre-vaccination responses 6 months after BNT162b2 vaccination for irradiated SARS-CoV-2 and S1. There was no correlation between BNT162b2 vaccination-induced anti-SARS-CoV2-receptor binding domain IgG antibody titre at V2 + 28 and cytokine responses.ConclusionsBNT162b2 vaccination in children alters cytokine responses to heterologous stimulants, particularly one month after vaccination. This study is the first to report the immunological heterologous effects of COVID-19 vaccination in children.

Published
2023
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5. BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial)

Author

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

Subjects
Medicine
Abstract

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.Trial registration ClinicalTrials.gov NCT04327206

Published
2021
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6. Establishing Intra- and Inter-Rater Agreement of the Face, Legs, Activity, Cry, Consolability Scale for Evaluating Pain in Toddlers During Immunization

Author

Rebecca J Gomez, Nick Barrowman, Sonja Elia, Elizabeth Manias, Jenny Royle, and Denise Harrison

Subjects
Medicine (General), R5-920
Abstract

BACKGROUND: The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a five-item tool that was developed to assess postoperative pain in young children. The tool is frequently used as an outcome measure in studies investigating acute procedural pain in young children; however, there are limited published psychometric data in this context.

Published
2013
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7. Influenza vaccine administration in a paediatric intensive care unit

Author

Sonja Elia, Yvette Moore, Trevor Duke, Nigel W Crawford, and Shidan Tosif

Subjects
Influenza Vaccines, Influenza, Human, Vaccination, Pediatrics, Perinatology and Child Health, Humans, Infant, Immunization, Child, Intensive Care Units, Pediatric
Abstract

We describe the clinical profile of children and outcomes of influenza immunisation for patients in a paediatric intensive care unit (PICU).Over two influenza seasons: 19/04/2018 to 07/08/2018 and 02/05/2019 to 10/10/2019, an immunisation nurse and PICU nurse coordinator met weekly and identified patients to receive the influenza vaccine. An inpatient list of PICU patients was screened for eligible patients: greater than 6 months of age, did not have imminent procedures (e.g. surgery) or were not critically unwell, as determined by the treating team, to receive the influenza vaccine. Patients were excluded if they had undergone surgery in the previous 24 hours or were being treated palliatively.Sixty patients in PICU were identified, with 43% (26/60) receiving the vaccine while in PICU and 17% (10/60) once discharged from PICU to the general ward environment. The majority of patients immunised were in PICU due to cardiac surgery/cardiology or general medical conditions, such as cerebral palsy or RSV bronchiolitis. There were no reported adverse events following immunisation.We have demonstrated the suitability and acceptability of children in the PICU receiving the seasonal influenza vaccine and tailored interventions to follow-up once discharged from PICU to optimise protection.

Published
2022

8. Minimising Immunisation Pain of childhood vaccines: The <scp>MIP</scp> pilot study

Author

Francesca Orsini, Kirsten P Perrett, Sonja Elia, and Narelle Jenkins

Subjects
medicine.medical_specialty, Pain, Pilot Projects, law.invention, 03 medical and health sciences, 0302 clinical medicine, Standard care, Randomized controlled trial, law, 030225 pediatrics, Humans, Medicine, 030212 general & internal medicine, Child, Vaccines, business.industry, Australia, Distress, Child, Preschool, Pediatrics, Perinatology and Child Health, Physical therapy, Anxiety, Immunization, Open label, medicine.symptom, business
Abstract

Aim Pain associated with immunisations can result in distress and/or anxiety for children and parents. We assessed the feasibility and acceptability of two novel devices; Coolsense (cold) and Buzzy (vibration ± cooling pads) versus standard care to minimise pain during immunisations. We also evaluated compliance to the devices and parent's perception of the effectiveness of the devices/standard care for minimising pain during immunisation. Design Open label, pilot, randomised controlled trial (RCT). Methods Forty children aged 3.5 to 6 years attending an Immunisation Centre at The Royal Children's Hospital in Melbourne, Australia, were randomised (1:1:1:1) into four groups: (i) Coolsense plus standard care; (ii) Buzzy with cold plus standard care; (iii) Buzzy without cold plus standard care; and (iv) Standard care alone (distraction with bubbles). Results and analysis Recruitment was completed in 12 days. Seventy percent were compliant with Buzzy (±cold), 82% with Coolsense, and 60% with standard care. Buzzy (with cold) was identified as effective by 70% of parents, Coolsense by 64%, Buzzy without cold by 50% and standard care by 60%. Conclusions This pilot study demonstrated feasibility. A larger RCT is needed to provide definitive evidence to inform best practice for minimising immunisation pain in young children.

Published
2020

9. Improving vaccination uptake with the implementation of an immunisation Nurse Practitioner

Author

Fiona Newall, Kirsten P Perrett, and Sonja Elia

Subjects
Advanced and Specialized Nursing, medicine.medical_specialty, Nurse practitioners, business.industry, Specialty, Successful completion, Vaccination, Current management, Family medicine, medicine, Vaccine-preventable diseases, Medical prescription, business, General Nursing, Clinical nursing
Abstract

Patients at increased risk of vaccine preventable diseases require additional vaccines that are not licensed for Nurse Immunisers to administer without a prescription. An Immunisation Nurse Practitioner (NP) at the Royal Children’s Hospital (RCH) Melbourne was introduced to address deficiencies in the current management of these patients. NP endorsement requires successful completion of a Masters level study program, plus the equivalent of three years (5,000) hours full-time experience in advanced clinical nursing. The Immunisation NP was endorsed in May 2017 and since then, the Immunisation service at RCH has recorded a 140% increase in uptake of Meningococcal B vaccine as well as improved delivery of immunisations to special-risk patients. In addition, there was improved access to specialist immunisation advice as well as improved opportunistic immunisation of inpatients. New initiatives were implemented including immunisation of needle phobic patients using nitrous oxide sedation. This paper describes the outcomes of employing an Immunisation NP at the RCH, Melbourne. What is currently known about the topic? Nurse Practitioners provide excellent, patient-centred care whilst also contributing to research, education, leadership and management. There is much literature on describing Nurse Practitioner specialty roles however, none in the area of Immunisation. What this paper adds: A Nurse Practitioner (NP) role in the specialty field of immunisation can contribute to improving hospital inpatient rates of immunisation, facilitate uptake of non-scheduled vaccines and decrease pressure on wait times for a specialist clinic appointment. The Immunisation NP reflects the full diversity of nursing practice and addresses the many service gaps in the previous delivery model, that can be emulated by paediatric nurses in other specialist areas.

Published
2021

10. Impact of Australian mandatory policies on immunisation services, parental attitudes to vaccination and vaccine uptake in a tertiary paediatric hospital

Author

Margie Danchin, Nigel W Crawford, Monsurul Hoq, Kirsten P Perrett, E Kua, Sonja Elia, and Raffaela Armiento

Subjects
Vaccination, medicine.medical_specialty, business.industry, Family medicine, Public Health, Environmental and Occupational Health, Medicine, business
Abstract

Introduction 'No Jab, No Play' and 'No Jab, No Pay' mandatory immunisation policies were introduced in the state of Victoria and Australia nationally in January 2016. They restrict access to childcare/kindergarten and family assistance payments respectively, for under-vaccinated children. We aimed to describe the proportion of attendees to immunisation services of a tertiary hospital, the Royal Children's Hospital Melbourne (RCH), who were motivated by the policies to discuss or catch up vaccination. We also explored the association between policy motivation, vaccine hesitancy (VH) and intent to seek medical exemption, with vaccine-uptake. Referrals to the Specialist Immunisation Clinic (SIC) were also reviewed. Methods Parents/Guardians and clinicians completed surveys October 2016-May 2017 from the nurse-led immunisation Drop in Centre (DIC) or physician-led SIC. Vaccine-uptake was measured using the Australian Immunisation Register at baseline, 1 and 7 months post-attendance. The association between vaccine-uptake, policy motivation and VH was explored by logistic regression. Results Of 607 children included, 393 (65%) were from the DIC and 214 (35%) SIC. 74 (12%) of parents were motivated by the policies to attend immunisation services and 19% were VH. Only 50% of VH parents planned to catch-up vaccination for enrolment to childcare/kindergarten. Fewer children were fully immunised at 7 months if their parents were VH (difference 18%; OR 0.24, CI 0.1-0.54,p Conclusions The 'No Jab' policies motivated attendance to a tertiary immunisation service but children of vaccine hesitant parents and those seeking medical exemption to immunisation were less likely to be fully immunised post attendance, compared to baseline. These data will be used to inform a comprehensive evaluation of the impact of the policies, particularly the educational impact from loss of early childhood education.

Published
2020

11. Impact of Australian mandatory 'No Jab, No Pay' and 'No Jab, No Play' immunisation policies on immunisation services, parental attitudes to vaccination and vaccine uptake, in a tertiary paediatric hospital, the Royal Children's Hospital, Melbourne

Author

Eugene Kua, Kirsten P Perrett, Sonja Elia, Monsurul Hoq, Margie Danchin, Nigel W Crawford, and Raffaela Armiento

Subjects
Parents, medicine.medical_specialty, Health Knowledge, Attitudes, Practice, Victoria, Target groups, Childhood vaccination, Health knowledge, Tertiary Care Centers, 03 medical and health sciences, 0302 clinical medicine, Vaccination status, 030225 pediatrics, medicine, Humans, 030212 general & internal medicine, Child, Motivation, Vaccines, General Veterinary, General Immunology and Microbiology, business.industry, Vaccination, Public Health, Environmental and Occupational Health, Attendance, Infant, Hospitals, Pediatric, Infectious Diseases, Policy, Immunization, Family medicine, Vaccine refusal, Molecular Medicine, business
Abstract

'No Jab, No Play' and 'No Jab, No Pay' mandatory immunisation policies were introduced in the state of Victoria and Australia-wide, respectively, in January 2016. They restrict access to childcare/kindergarten and family assistance payments respectively, for under-vaccinated children. We aimed to describe the proportion of attendees to immunisation services of a tertiary hospital, the Royal Children's Hospital Melbourne (RCH), who were motivated by the policies to discuss or catch-up vaccination. We explored the association between motivation by policies, vaccine hesitancy (VH) and intent to seek medical exemption, with vaccine-uptake.Parents/Guardians and clinicians completed surveys October 2016-May 2017 from the nurse-led immunisation Drop in Centre (DIC) or physician-led Specialist Immunisation Clinic (SIC). Vaccine-uptake was measured using the Australian Immunisation Register (AIR) at baseline, 1 and 7 months post-attendance. The association between vaccine-uptake, motivation by policies and VH was explored by logistic regression.Of 607 children, 393 (65%) were from the DIC and 214 (35%) SIC. 74 (12%) parents were motivated by the policies to attend immunisation services and 19% were VH. Only 50% of VH parents planned to catch-up vaccination for enrolment to childcare/kindergarten. Seven months post-attendance there was no association between motivation by policies and full vaccination status (difference 10%, OR 0.42, CI 0.17-1.1, p 0.08). Fewer children were fully immunised at 7 months if their parents were VH (difference 18%; OR 0.24, CI 0.1-0.54, p 0.001) or seeking medical exemption (difference 33%, OR 0.08, CI 0.01-0.6, p 0.015).The 'No Jab' policies motivated attendance to a tertiary immunisation service. However, children of vaccine hesitant parents and those seeking medical exemption to immunisation were less likely to be fully immunised after attendance, than at baseline. The 'No Jab' policies may not be changing vaccination behavior as intended for vaccine hesitant parents who are one of the key target groups, with further evaluation required.

Published
2020

12. Recurrence risk of a hypotonic hyporesponsive episode in two Australian specialist immunisation clinics

Author

Jim Buttery, Jenny Royle, Teresa Lazzaro, Karen Orr, Nicholas Wood, Kirsten P Perrett, Alissa McMinn, Sonja Elia, Margie Danchin, and Nigel W Crawford

Subjects
Adult, Pediatrics, medicine.medical_specialty, Adolescent, Recurrence risk, Young Adult, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Adverse Drug Reaction Reporting Systems, Humans, Medicine, 030212 general & internal medicine, Young adult, Child, Adverse effect, Retrospective Studies, General Veterinary, General Immunology and Microbiology, business.industry, Australia, Public Health, Environmental and Occupational Health, Infant, Retrospective cohort study, Hospitals, Confidence interval, Vaccination, Hypotonic-Hyporesponsive Episode, Infectious Diseases, Immunization, Child, Preschool, Muscle Hypotonia, Molecular Medicine, business
Abstract

Background A hypotonic hyporesponsive episode (HHE) is a well-described adverse event following immunisation (AEFI) in young children. There is limited data regarding recurrence post re-vaccination. Method A retrospective analysis of HHEs reported to two tertiary paediatric hospitals in Australia: The Royal Children’s Hospital, Melbourne [2006–11] and the Children’s Hospital Westmead, Sydney [1997–2014]. HHE definition level of confidence was allocated according to Brighton Collaboration (BC) criteria and defined immediate if within 30 min post vaccination. The Australian Immunisation Register (AIR) was utilised to document current immunisation status. Results 235 HHE cases (135 Melbourne, 100 Sydney) were identified: 47% were female and 67% (157/235) occurred following the routine dose one vaccines at 6–8 weeks of age. Median time following immunisation was 120 min (range 1 min to 14 days) An immediate HHE occurred in 43% (102/235) and by BC criteria, 74% (173/235) were level 1 (definite). Subsequent vaccines were administered under supervision in hospital in 37% overall (86/235); 43% (58/135) in Melbourne and 28% (28/100) in Sydney. HHE recurrence rate was 3% (7/235) [95% confidence interval 1–6%]. AIR records were available in 94% (221/235). At a median age of 3.1 years, 84% (186/221) were up-to-date with recommended vaccines. Conclusion This study highlights the importance of specialist immunization clinics in supporting the National Immunisation Program, through follow-up and management of serious adverse events following immunization.

Published
2018

13. Immunizations under sedation at a paediatric hospital in Melbourne, Australia from 2012–2016

Author

Kirsten P Perrett, Sonja Elia, and Daryl R. Cheng

Subjects
Male, medicine.medical_specialty, Adolescent, Midazolam, Sedation, Conscious Sedation, Nitrous Oxide, Phobic disorder, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030225 pediatrics, Humans, Hypnotics and Sedatives, Medicine, 030212 general & internal medicine, Child, Retrospective Studies, General Veterinary, General Immunology and Microbiology, business.industry, Medical record, Australia, Public Health, Environmental and Occupational Health, Retrospective cohort study, Hospitals, Pediatric, Vaccination, Infectious Diseases, Phobic Disorders, Needles, Anesthetics, Inhalation, Emergency medicine, Molecular Medicine, Anxiety, Female, Immunization, medicine.symptom, business, medicine.drug
Abstract

Background Sedation for immunizations is of particular importance in a subset of paediatric patients with anxiety disorders, needle phobia, developmental or behavioural disorders. The Royal Children’s Hospital (RCH) Melbourne offers a unique immunization under sedation service for these patients. We aimed to evaluate the number and types of patients using inpatient sedation for immunizations, distraction and sedation techniques used, and outcomes of these procedures. Methods A medical record review was conducted on all patients who had immunization under sedation between January 2012 to December 2016 in the RCH Day Medical Unit (DMU). Results A total of 139 children and adolescents had 213 vaccination encounters. More than half of the vaccination encounters involved multiple vaccines. A total of 400 vaccines were administered. One third of patients (32.3%) had multiple DMU admissions for vaccinations. The median age of patients was 13 years. There were only 10 (4.7%) failed attempts at vaccination; all due to patient non-compliance with prescribed sedation. The majority of patients (58.9%) had a diagnosis of needle phobia. Sedation was most commonly adequately achieved with inhaled nitrous oxide (54.7% sole agent). Midazolam was often used as an adjunct therapy (42.8%). Local anaesthetic cream or play therapy, were used in only 5.9% and 3.9% of patients respectively, although this may reflect poor documentation rather than actual practice. Conclusions For a subset of paediatric patients for which standard immunization procedures have failed, distraction techniques and conscious sedation enable immunizations to be given safely and effectively. Future research will develop protocols to streamline immunization procedures under sedation.

Published
2018

14. Human papillomavirus vaccine uptake in adolescents with developmental disabilities

Author

Sonja Elia, Kirsten P Perrett, and Jenny O'Neill

Subjects
030506 rehabilitation, Pediatrics, medicine.medical_specialty, business.industry, Incidence (epidemiology), 05 social sciences, virus diseases, Human papillomavirus vaccine, medicine.disease, female genital diseases and pregnancy complications, Education, 03 medical and health sciences, fluids and secretions, Arts and Humanities (miscellaneous), Immunology, Intellectual disability, Medicine, 0501 psychology and cognitive sciences, Human papillomavirus, 0305 other medical science, business, General Psychology, 050104 developmental & child psychology
Abstract

Background: The Human Papillomavirus (HPV) vaccine is offered in Australia to all males and females at 12 to 13 years. In 2015 the national HPV coverage was 77.4% for females and 66.4% for males. T...

Published
2017

15. No jab, no record: Catch-up vaccination of children in immigration detention

Author

Karen Kiang, Georgia A Paxton, and Sonja Elia

Subjects
medicine.medical_specialty, business.industry, Refugee, International health, Audit, Vaccination, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Family medicine, Pediatrics, Perinatology and Child Health, Cohort, Medicine, 030212 general & internal medicine, Community standards, Asylum seeker, business, Immigration detention
Abstract

International Health and Medical Services (IHMS) are contracted to provide health services, including catch-up vaccination, for individuals in immigration detention. Our audit of catch-up vaccination in asylum seeker children who spent time in held detention demonstrates inadequate and suboptimal vaccine delivery in this setting, and no evidence that IHMS recorded vaccines on the Australian Childhood Immunisation Register at the time. We also found substantial shortfalls in vaccination for these children after they were released from detention. Immunisation in this cohort falls well below Australian community standards, does not demonstrate assurance in IHMS provision of care, and has implications for similar asylum seeker cohorts nationally as well as people in held detention.

Published
2018

16. Distribution of Bacillus Calmette-Guérin (BCG) Vaccine in Victoria 2013-2015

Author

Nicole X, Wong, Nigel, Crawford, Jock, Lawrie, Jo, Hickman, Sonja, Elia, and Jim, Buttery

Abstract

The Bacillus Calmette-Guérin (BCG) vaccine has an important role mitigating tuberculosis (TB) disease in high risk children. In Victoria, immunisation services at the Royal Children's Hospital (RCH) and Monash Health (MH) have been funded as the major providers of BCG vaccine since 2013.In this article, we performed retrospective analysis of patients who attended RCH and MH for BCG between 1st November 2013- 30th November 2015. This was compared with local birth data in order to portray the distribution of BCG vaccine across various cohorts.A total of 3,975 patients received BCG vaccine (1,775 at Monash, 2,200 from RCH). Detailed data is only available on 830 RCH patients. The median age of the study population was 6.9 months (IQR 3.9-11.3). The majority of children (98.9%, 2,575/2,604) received BCG vaccine prior to overseas travel. Of these, 96.0% (2,474/2,575) were travelling to countries in Asia. Only 13/2,604 (0.5%) were given BCG vaccine prior to travel to a country with low incidence of TB. Most infants were of Asian descent (93.3% mothers [2,425/2,604], 90.4% [2,346/2,604] fathers). A much smaller proportion was African (1.4% mothers [35/2,604], 1.5% [39/2,604] fathers). This contrasts with 2012 Victorian birth data, which showed that 82.2% (7,508/ 9,134) babies born to mothers from high TB prevalence countries were of Asian descent, whereas 8.9% (816/ 9,134) were of African descent. These results highlight scope to improve awareness and equity of BCG vaccine service, particularly to infants of African background.

Published
2019

17. No jab, no record: Catch-up vaccination of children in immigration detention

Author

Karen M, Kiang, Sonja, Elia, and Georgia A, Paxton

Subjects
Male, Refugees, Vaccination, Australia, Humans, Female, Emigration and Immigration, Child
Abstract

International Health and Medical Services (IHMS) are contracted to provide health services, including catch-up vaccination, for individuals in immigration detention. Our audit of catch-up vaccination in asylum seeker children who spent time in held detention demonstrates inadequate and suboptimal vaccine delivery in this setting, and no evidence that IHMS recorded vaccines on the Australian Childhood Immunisation Register at the time. We also found substantial shortfalls in vaccination for these children after they were released from detention. Immunisation in this cohort falls well below Australian community standards, does not demonstrate assurance in IHMS provision of care, and has implications for similar asylum seeker cohorts nationally as well as people in held detention.

Published
2017

18. Pain management strategies used during early childhood immunisation in Victoria

Author

Elizabeth Manias, Jenny Royle, Sonja Elia, and Denise Harrison

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Breastfeeding, Frequency of use, MEDLINE, Special Interest Group, Pain management, Distraction, Pediatrics, Perinatology and Child Health, Medicine, Early childhood, business, Breast feeding
Abstract

Aim The study aims to identify pain management practices used during scheduled childhood immunisation. Methods A survey of members of the Australian Nurses Federation (Victorian Branch) Immunisation Nurses Special Interest Group. Questions included frequency of use of pain reduction strategies during immunisations for infants, toddlers and children, injection techniques and existence of an articulated pain management policy. Results The survey was emailed to 274 Immunisation Nurses Special Interest Group members with registered email addresses, and 125 (46%) completed the survey. Nineteen respondents (15.2%) stated their main place of employment had a pain management policy during immunisations and 20 (16.0%) respondents were not sure. Distraction strategies were frequently used during immunisation for all age groups, with 95 (76.0%) replying that distraction was used often or always. Breastfeeding during immunisation for infants younger than 6 months was used occasionally (n = 54, 44.6%), often (n = 11, 9.1%) or never (n = 55, 45.5%) and was used even less frequently for infants aged 6–12 months. Sucrose or other sweet solutions were almost never used for infants prior to, or during, immunisation. As a reward, lollies were frequently given to children after immunisations. Topical anaesthetics were almost never used in any age groups. Over half the respondents used a rapid injection technique; 55 (44.7%) used a slow technique and four respondents aspirated the needle before injections. Conclusions Many distraction strategies were used during and following immunisation but sweet solutions, breastfeeding or topical anaesthetics were rarely used. Use of these strategies where feasible, should be facilitated in diverse settings where immunisations take place.

Published
2013

19. Providing opportunistic immunisations for at-risk inpatients in a tertiary paediatric hospital

Author

Sonja, Elia, Kirsten, Perrett, and Fiona, Newall

Subjects
Male, Inpatients, Risk Management, Adolescent, Vaccination, Australia, Infant, Hospitals, Pediatric, Pediatric Nursing, Tertiary Care Centers, Child, Preschool, Practice Guidelines as Topic, Humans, Female, Immunization, Child
Abstract

Attaining high immunisation coverage rates for children with medical conditions is vital. The Royal Children's Hospital (RCH) Immunisation Service has the opportunity to check each inpatient's immunisation status and provide opportunistic vaccines and/or bring the Australian Childhood Immunisation Register (ACIR) up-to-date. This paper highlights that during admission, one quarter of children were not up-to-date with routine scheduled immunisations and 42% of those inpatients due or overdue for immunisation were vaccinated. The model of establishing routine checking of immunisation records and reminding hospital staff about immunisation can result in improvements in vaccination coverage. Healthcare providers have a responsibility to check immunisation status and offer vaccines when necessary; however, often there are missed opportunities to immunise. This paper demonstrates that having a dedicated Immunisation Service, a partnership with a relevant government agency, and effective collaboration with inpatient clinical teams, opportunistic immunisation can be achieved for inpatients.

Published
2016

20. Immunisation rates of children with cystic fibrosis using the Australian Childhood Immunisation Register

Author

Sonja Elia, Nigel W Crawford, John Massie, Jenny Royle, and Kathryn Cugley

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Influenza vaccine, Immunisation status, medicine.disease, Cystic fibrosis, Vaccination, Immunization, Pneumococcal vaccine, Pediatrics, Perinatology and Child Health, Medicine, Outpatient clinic, business, Childhood immunisation
Abstract

Aim: The Australian Immunisation Handbook (ninth edition) recommends children with cystic fibrosis (CF) receive routine scheduled immunisations plus annual influenza vaccine and an additional pneumococcal vaccine at both 12 months and 4–5 years. Adherence with these recommendations is unknown. This study aimed to determine the immunisation status of children with CF attending the Royal Children's Hospital (RCH), Melbourne. Methods: A retrospective audit of children with CF aged 6 months to 7 years (at 1 January 2008) was performed on the RCH CF outpatient clinic database. The Australian Childhood Immunisation Register (ACIR) and RCH Immunisation Service records were used to determine immunisation status. Results: Eighty-nine children with CF were identified, 52 (58%) were male, with median age of 3.6 years. Eighty-two of 89 children (92%) were up to date with routine immunisations. According to the ACIR, of the 89 children sampled, 24 (27%) were given influenza vaccine in accordance with recommendations in 2007. Eighty children were older than 12 months of age at 1 January 2008 and 17 (21%) of these children had received the additional pneumococcal vaccine at 12 months. Thirty-eight children were older than 4 years of age at 1 January 2008 and 6 (16%) received the recommended 23vPPV booster. Conclusion: Most children with CF received their routine childhood immunisations but not the additional recommended immunisations. This highlights the potential value of the ACIR to accurately record all vaccines administered and for ACIR reminder letters to include the additional vaccines for children in special-risk groups.

Published
2010

21. Providing opportunistic immunisations for at-risk inpatients in a tertiary paediatric hospital

Author

Kirsten P Perrett, Fiona Newall, and Sonja Elia

Subjects
Government, business.industry, Immunisation status, medicine.disease, Pediatrics, Vaccination, 03 medical and health sciences, 0302 clinical medicine, Immunization, 030225 pediatrics, Vaccination coverage, medicine, 030212 general & internal medicine, Medical emergency, Pediatric nursing, business, Healthcare providers, Childhood immunisation
Abstract

Attaining high immunisation coverage rates for children with medical conditions is vital. The Royal Children's Hospital (RCH) Immunisation Service has the opportunity to check each inpatient's immunisation status and provide opportunistic vaccines and/or bring the Australian Childhood Immunisation Register (ACIR) up-to-date. This paper highlights that during admission, one quarter of children were not up-to-date with routine scheduled immunisations and 42% of those inpatients due or overdue for immunisation were vaccinated. The model of establishing routine checking of immunisation records and reminding hospital staff about immunisation can result in improvements in vaccination coverage. Healthcare providers have a responsibility to check immunisation status and offer vaccines when necessary; however, often there are missed opportunities to immunise. This paper demonstrates that having a dedicated Immunisation Service, a partnership with a relevant government agency, and effective collaboration with inpatient clinical teams, opportunistic immunisation can be achieved for inpatients.

Published
2017

22. Syncope and seizures following human papillomavirus vaccination: a retrospective case series

Author

Hazel J Clothier, Jenny Royle, Jim Buttery, Sonja Elia, Teresa Lazzaro, and Nigel W Crawford

Subjects
Adult, Pediatrics, medicine.medical_specialty, Adolescent, Neurological disorder, Syncope, Young Adult, Epilepsy, Seizures, Convulsion, Adverse Drug Reaction Reporting Systems, Humans, Medicine, Papillomavirus Vaccines, Child, Adverse effect, Retrospective Studies, biology, business.industry, Incidence (epidemiology), Syncope (genus), Retrospective cohort study, General Medicine, medicine.disease, biology.organism_classification, Vaccination, Anesthesia, Female, medicine.symptom, business
Abstract

Objective To quantify and characterise the reports of syncope and seizures following quadrivalent (4v) human papillomavirus (HPV) vaccination. Design and setting Retrospective case series of notifications to SAEFVIC (Surveillance of Adverse Events Following Vaccination In the Community), May 2007 - April 2009. Main outcome measures Incidence of syncope and seizure following 4vHPV vaccination; clinical outcomes. Results 97/1653 SAEFVIC reports met the study criteria: afebrile seizures (3), syncopal seizures (31) and syncope alone (63). Median age at vaccination was 15 years (range, 8-26 years). Injuries were reported in seven cases, including one vertebral fracture. A SAEFVIC clinic review was undertaken in 41% (40/97) and 22 patients received further 4vHPV vaccine doses administered supine, with no recurrences. The reporting rate after 4vHPV vaccine for syncope and syncopal seizures was 7.8/100, 000 and 2.6/100, 000 doses distributed, respectively. Conclusion Syncope and syncopal seizures occurred after 4vHPV vaccination in Victoria at rates similar to those seen internationally. Clinical review allowed clarification of the diagnosis and management, including safe administration of further doses under supervision.

Published
2011

23. Establishing intra- and inter-rater agreement of the Face, Legs, Activity, Cry, Consolability scale for evaluating pain in toddlers during immunization

Author

Jenny Royle, Sonja Elia, Elizabeth Manias, Nick Barrowman, Rebecca J Gomez, and Denise Harrison

Subjects
Male, medicine.medical_specialty, Psychometrics, Pain, Context (language use), Crying, Motor Activity, Pediatrics, medicine, Humans, Pain Measurement, Randomized Controlled Trials as Topic, Observer Variation, lcsh:R5-920, Leg, Reproducibility of Results, Procedural Pain, Inter-rater reliability, Anesthesiology and Pain Medicine, Neurology, Scale (social sciences), Child, Preschool, Face, FLACC scale, Physical therapy, Original Article, Female, Immunization, medicine.symptom, lcsh:Medicine (General), Psychometric data, Psychology
Abstract

BACKGROUND: The Face, Legs, Activity, Cry, Consolability (FLACC) scale is a five-item tool that was developed to assess postoperative pain in young children. The tool is frequently used as an outcome measure in studies investigating acute procedural pain in young children; however, there are limited published psychometric data in this context.OBJECTIVE: To establish inter-rater and intrarater agreement of the FLACC scale in toddlers during immunization.METHODS: Participants comprised a convenience sample of toddlers recruited from an immunization drop-in service, who were part of a larger pilot randomized controlled trial. Toddlers were video- and audiotaped during immunization procedures. The first rater scored each video twice in random order over a period of three weeks (intrarater agreement), while the second rater scored each video once and was blinded to the first rater’s scores (inter-rater agreement). The FLACC scale was scored at four time-points throughout the procedure. Intraclass correlation coefficients were used to assess agreement of the FLACC scale.RESULTS: Thirty toddlers between 12 and 18 months of age were recruited, and video data were available for 29. Intrarater agreement coefficients were 0.88 at baseline, 0.97 at insertion of first needle, and 0.80 and 0.81 at 15 s and 30 s following the final injection, respectively. Inter-rater coefficients were 0.40 at baseline, 0.95 at insertion of first needle, and 0.81 and 0.78 at 15 s and 30 s following the final injection, respectively.CONCLUSIONS: The FLACC scale has sufficient agreement in assessing pain in toddlers during immunizations, especially during the most painful periods of the procedure.

Published
2013

24. Pain management strategies used during early childhood immunisation in Victoria

Author

Denise, Harrison, Sonja, Elia, Jenny, Royle, and Elizabeth, Manias

Subjects
Breast Feeding, Victoria, Child, Preschool, Health Care Surveys, Sweetening Agents, Humans, Infant, Pain Management, Immunization, Anesthetics, Local, Play and Playthings
Abstract

The study aims to identify pain management practices used during scheduled childhood immunisation.A survey of members of the Australian Nurses Federation (Victorian Branch) Immunisation Nurses Special Interest Group. Questions included frequency of use of pain reduction strategies during immunisations for infants, toddlers and children, injection techniques and existence of an articulated pain management policy.The survey was emailed to 274 Immunisation Nurses Special Interest Group members with registered email addresses, and 125 (46%) completed the survey. Nineteen respondents (15.2%) stated their main place of employment had a pain management policy during immunisations and 20 (16.0%) respondents were not sure. Distraction strategies were frequently used during immunisation for all age groups, with 95 (76.0%) replying that distraction was used often or always. Breastfeeding during immunisation for infants younger than 6 months was used occasionally (n = 54, 44.6%), often (n = 11, 9.1%) or never (n = 55, 45.5%) and was used even less frequently for infants aged 6-12 months. Sucrose or other sweet solutions were almost never used for infants prior to, or during, immunisation. As a reward, lollies were frequently given to children after immunisations. Topical anaesthetics were almost never used in any age groups. Over half the respondents used a rapid injection technique; 55 (44.7%) used a slow technique and four respondents aspirated the needle before injections.Many distraction strategies were used during and following immunisation but sweet solutions, breastfeeding or topical anaesthetics were rarely used. Use of these strategies where feasible, should be facilitated in diverse settings where immunisations take place.

Published
2012

25. Immunisation rates of children with cystic fibrosis using the Australian Childhood Immunisation Register

Author

Kathryn, Cugley, Nigel, Crawford, Jenny, Royle, Sonja, Elia, and John, Massie

Subjects
Male, Cystic Fibrosis, Immunization Programs, Child, Preschool, Australia, Humans, Infant, Female, Registries, Child, Retrospective Studies
Abstract

The Australian Immunisation Handbook (ninth edition) recommends children with cystic fibrosis (CF) receive routine scheduled immunisations plus annual influenza vaccine and an additional pneumococcal vaccine at both 12 months and 4-5 years. Adherence with these recommendations is unknown. This study aimed to determine the immunisation status of children with CF attending the Royal Children's Hospital (RCH), Melbourne.A retrospective audit of children with CF aged 6 months to 7 years (at 1 January 2008) was performed on the RCH CF outpatient clinic database. The Australian Childhood Immunisation Register (ACIR) and RCH Immunisation Service records were used to determine immunisation status.Eighty-nine children with CF were identified, 52 (58%) were male, with median age of 3.6 years. Eighty-two of 89 children (92%) were up to date with routine immunisations. According to the ACIR, of the 89 children sampled, 24 (27%) were given influenza vaccine in accordance with recommendations in 2007. Eighty children were older than 12 months of age at 1 January 2008 and 17 (21%) of these children had received the additional pneumococcal vaccine at 12 months. Thirty-eight children were older than 4 years of age at 1 January 2008 and 6 (16%) received the recommended 23vPPV booster.Most children with CF received their routine childhood immunisations but not the additional recommended immunisations. This highlights the potential value of the ACIR to accurately record all vaccines administered and for ACIR reminder letters to include the additional vaccines for children in special-risk groups.

Published
2010

26. Hypersensitivity reactions to human papillomavirus vaccine in Australian schoolgirls: retrospective cohort study

Author

Jenny Royle, Jim Buttery, Liew Woei Kang, Mimi L.K. Tang, Patrick Quinn, Michael Gold, Sonja Elia, Christine Ziegler, Nigel W Crawford, and Sharon Choo

Subjects
Pediatrics, medicine.medical_specialty, Allergy, Adolescent, Victoria, Adolescent Health, Dermatology, Cohort Studies, Drug Hypersensitivity, Papillomavirus Vaccines, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, South Australia, Medicine, Humans, General Environmental Science, Retrospective Studies, Immunology (Including Allergy), business.industry, Research, Papillomavirus Infections, General Engineering, Child Health, Retrospective cohort study, General Medicine, medicine.disease, Vaccination, Epidemiologic Studies, Clinical research, El Niño, Immunology, General Earth and Planetary Sciences, Female, business, Anaphylaxis, Cohort study
Abstract

OBJECTIVE: To describe the outcomes of clinical evaluation, skin testing, and vaccine challenge in adolescent schoolgirls with suspected hypersensitivity to the quadrivalent human papillomavirus vaccine introduced in Australian schools in 2007. DESIGN: Retrospective cohort study. SETTING: Two tertiary paediatric allergy centres in Victoria and South Australia, Australia. PARTICIPANTS: 35 schoolgirls aged 12 to 18.9 years with suspected hypersensitivity reactions to the quadrivalent human papillomavirus vaccine. MAIN OUTCOME MEASURES: Clinical review and skin prick and intradermal testing with the quadrivalent vaccine and subsequent challenge with the vaccine. RESULTS: 35 schoolgirls with suspected hypersensitivity to the quadrivalent human papillomavirus vaccine were notified to the specialised immunisation services in 2007, after more than 380 000 doses had been administered in schools. Of these 35 schoolgirls, 25 agreed to further evaluation. Twenty three (92%) experienced reactions after the first dose. Thirteen (52%) experienced urticaria or angio-oedema, and of these, two experienced anaphylaxis. Thirteen had generalised rash, one with angio-oedema. The median time to reaction was 90 minutes. Nineteen (76%) underwent skin testing with the quadrivalent vaccine: all were skin prick test negative and one was intradermal test positive. Eighteen (72%) were subsequently challenged with the quadrivalent vaccine and three (12%) elected to receive the bivalent vaccine. Seventeen tolerated the challenge and one reported limited urticaria four hours after the vaccine had been administered. Only three of the 25 schoolgirls were found to have probable hypersensitivity to the quadrivalent vaccine. CONCLUSION: True hypersensitivity to the quadrivalent human papillomavirus vaccine in Australian schoolgirls was uncommon and most tolerated subsequent doses.

Published
2008

27. Mass psychogenic response to human papillomavirus vaccination

Author

Bruce Bolam, Jim Buttery, Sarah Hanieh, Sophie La Vincente, Nigel W Crawford, Simon Madin, Lindsay J Smith, and Sonja Elia

Subjects
Adolescent, business.industry, Australia, General Medicine, Virology, Mass Vaccination, Human papillomavirus vaccination, Vaccination, Papillomavirus Vaccines, Immunology, Psychogenic disease, Medicine, Adverse Drug Reaction Reporting Systems, Humans, Mass vaccination, Female, Viral disease, Human papillomavirus, business, Child, Somatoform Disorders, Mass Behavior, School Health Services
Published
2008

28. Effect of a postcard immunisation reminder in hospital outpatients: A randomised controlled trial.

Author

Crawford N., Buttery J., Royle J., Sonja Elia R.N., South M., Crawford N., Buttery J., Royle J., Sonja Elia R.N., and South M.

Abstract

Background: Missed immunisation opportunities occur at hospital outpatient visits. The Australian Childhood Immunisation Register (ACIR) identifies children <7 years not up-to-date with routine immunisations, but is under-utilised in hospitals. Aim(s): To determine whether a randomly assigned postcard-size immunisation reminder, provided at the clinic visit for 'not up-to-date' children, could facilitate catch-up immunisation within 3 and 12 months. Method(s): All children <7 years attending the Royal Children's Hospital (RCH) outpatients and not up-to-date according to ACIR were identified. Exclusion criteria included attending an immunosuppression clinic or allied-health appointment. On alternate days, rotating weekly, immunisation reminder postcards were distributed to identified parents and the clinic doctor. The postcard also highlighted the RCH Immunisation Drop-in Centre as a place to discuss immunisations. Individual ACIR records were reviewed again 3 and 12 months post the initial visit. Result(s): Between 28 February - 25 August 2008, 1563 children were flagged by ACIR [332 misclassified; 102 allied health clinics; 15 immunosuppression clinic], leaving 1114 study participants [648 control; 466 intervention group]. At 3 months 26.5% (123/464) were up-to-date in the intervention group, 0.4% greater than controls [Odds ration (OR) 1.02 (95% confidence intervals (CI) 0.77; 1.36), P = 0.88]. At 12 months 31.2% (144/462) were up-to-date in the intervention group, controls 31.1% (OR 1.00 [95% CI 0.77; 1.31] P = 0.98). In univariate analysis medical appointments versus surgical were 1.6% more likely to be up-to-date at 3 months (P = 0.65). 27 patients attended the Drop-in Centre; 10 had ACIR records updated and 65% (11/17) requiring vaccines had them administered. Conclusion(s): The postcard reminder did not provide additional benefit regarding up-to-date status. The ability to link outpatient appointments with immunisation outcomes was established. The proposed i

Published
2011

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