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1. 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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2. 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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3. Vaccines for COVID-19: Where do we stand in 2021?

Author

Archana Koirala, Philip N Britton, Clayton Chiu, Katrina Nicolopoulos, Nicholas Wood, and Ketaki Sharma

Subjects
Pulmonary and Respiratory Medicine, COVID-19 Vaccines, Special populations, Adolescent, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Distribution (economics), Environmental health, Humans, Medicine, Child, Drug Approval, Pandemics, 11 Medical and Health Sciences, Vaccines, SARS-CoV-2, business.industry, COVID-19, Coronavirus, Clinical trial, Vaccination, 1107 Immunology, Pediatrics, Perinatology and Child Health, Observational study, Mini-symposium: COVID 19: The second year, business, High income countries
Abstract

As of July 2021, over 3 billion doses of a COVID-19 vaccines have been administered globally, and there are now 19 COVID-19 vaccines approved for use in at least one country. Several of these have been shown to be highly effective both in clinical trials and real-world observational studies, some of which have included special populations of interest. A small number of countries have approved a COVID-19 vaccine for use in adolescents or children. These are laudable achievements, but the global vaccination effort has been challenged by inequitable distribution of vaccines predominantly to high income countries, with only 0.9% of people in low-income countries having received at least one dose of a COVID-19 vaccine. Addressing this inequity is of critical importance and will result in better control of SARS-CoV-2 globally. Other challenges include: the reduced protection from COVID-19 vaccines against some strains of SARS-CoV-2, necessitating the development of variant specific vaccines; and uncertainties around the duration of protection from vaccine-induced immunity.

Published
2021
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4. Alignment of national COVID-19 vaccine recommendations for pregnant and lactating women

Author

Michelle L. Giles, Ketaki Sharma, Vijay Roach, Kirsten R Palmer, and Ahinsa Gunatilaka

Subjects
medicine.medical_specialty, COVID-19 Vaccines, Breastfeeding, law.invention, law, Pregnancy, Pandemic, medicine, Humans, Lactation, Government, business.industry, SARS-CoV-2, Vaccination, Public Health, Environmental and Occupational Health, COVID-19, medicine.disease, Clinical trial, Policy & Practice, Family medicine, CLARITY, Professional association, Female, Pregnant Women, business
Abstract

The rapid development and roll-out of coronavirus disease 2019 (COVID-19) vaccines is providing hope for a way to control the pandemic. As pregnant and lactating women are generally excluded from clinical trials, the vaccination programme was launched without adequate safety and efficacy data for pregnant women. Yet many professional organizations have recognized the need for administration of COVID-19 vaccines in pregnancy and have issued their own set of recommendations. The lack of evidence, however, has often led to confused messaging, inconsistent language and differing recommendations across organizations, potentially contributing to delay or refusal to accept vaccination by pregnant women. We summarize those differences and recommend that leaders collaborate at a country level to produce joint recommendations. We use the example of Australia, where two professional authorities along with the government and partners in New Zealand worked towards one message, consistent language and a unified recommendation. The aim was to help health professionals and women who are planning pregnancy or who are currently pregnant or breastfeeding to make an informed decision about COVID-19 vaccination. National advisory groups for immunization, professional obstetric organizations and government bodies should be encouraged to coordinate their statements on COVID-19 vaccination for pregnant and lactating women and to use similar language and phrasing for greater clarity.La rapidité de développement et de déploiement des vaccins contre la maladie à coronavirus 2019 (COVID-19) entretient l'espoir d'un jour pouvoir contrôler la pandémie. Étant donné que les femmes enceintes et allaitantes sont généralement exclues des essais cliniques, le programme de vaccination a été lancé en l'absence de données adéquates sur l'efficacité et l'innocuité du vaccin au sein de cette catégorie. Pourtant, de nombreuses associations professionnelles ont reconnu la nécessité de vacciner contre la COVID-19 durant la grossesse, et ont émis leurs propres recommandations. L'absence de preuves a toutefois souvent donné lieu à une communication incohérente, à un discours contradictoire et à des recommandations divergentes d'une organisation à l'autre, ce qui pourrait avoir conduit certaines femmes enceintes à retarder ou refuser la vaccination. Dans le présent document, nous exposons ces différences et exhortons les dirigeants à collaborer au niveau national pour formuler des recommandations communes. Nous utilisons l'exemple de l'Australie, où deux autorités professionnelles ont travaillé avec le gouvernement et des partenaires en Nouvelle-Zélande afin de transmettre un message unique, d'adopter un langage cohérent et de fournir des directives homogènes. L'objectif était d'aider les soignants et les femmes enceintes, allaitantes ou planifiant une grossesse à prendre une décision éclairée en matière de vaccination contre la COVID-19. Les organes consultatifs nationaux sur la vaccination, les associations professionnelles d'obstétrique et les pouvoirs publics devraient être encouragés à aligner leurs déclarations concernant la vaccination contre la COVID-19 chez les femmes enceintes et allaitantes, ainsi qu'à employer des termes et énoncés similaires pour davantage de clarté.El rápido desarrollo y puesta en marcha de las vacunas contra el coronavirus de la enfermedad por coronavirus (COVID-19) está dando esperanzas sobre una forma de controlar la pandemia. Como las mujeres embarazadas y lactantes suelen estar excluidas de los ensayos clínicos, el programa de vacunación se puso en marcha sin datos adecuados de seguridad y eficacia para las mujeres embarazadas. Sin embargo, muchas organizaciones profesionales han reconocido la necesidad de administrar las vacunas contra la COVID-19 durante el embarazo y han emitido su propio conjunto de recomendaciones. Sin embargo, la falta de pruebas a menudo ha ocasionado mensajes confusos, un lenguaje incoherente y recomendaciones diferentes en las distintas organizaciones, lo que puede contribuir a retrasar o rechazar la vacunación de las mujeres embarazadas. Resumimos esas diferencias y recomendamos que los líderes colaboren a nivel de país para elaborar recomendaciones conjuntas. Utilizamos el ejemplo de Australia, donde dos autoridades profesionales, junto con el gobierno y los socios de Nueva Zelanda, trabajaron para lograr transmitir un único mensaje con un lenguaje coherente y una recomendación unificada. El objetivo era ayudar a los profesionales sanitarios y a las mujeres que planean un embarazo o embarazadas o en periodo de lactancia a tomar una decisión informada sobre la vacunación contra la COVID-19. Hay que animar a los grupos consultivos nacionales de inmunización, a las organizaciones profesionales de obstetricia y a los organismos gubernamentales a que coordinen sus declaraciones sobre la vacunación contra la COVID-19 para las mujeres embarazadas y lactantes y a que utilicen un lenguaje y una redacción similares para mayor claridad.إن التطور والطرح السريع للقاحات مرض فيروس كورونا 2019 (كوفيد 19)، يمنحان الأمل في توفير طريقة للسيطرة على الجائحة. ونظرًا لأن النساء الحوامل والمرضعات يتم استبعادهن عمومًا من التجارب الإكلينيكية، فقد تم إطلاق برنامج التطعيم دون توفر بيانات كافية عن السلامة والفعالية بالنسبة للحوامل. إلا أن العديد من المنظمات المهنية قد أدركت الحاجة إلى إعطاء لقاحات كوفيد 19 أثناء الحمل، وأصدرت مجموعة من التوصيات الخاصة بها. ومع ذلك، فقد أدى الافتقار لوجود أدلة في كثير من الأحيان إلى رسائل مربكة، ولغة غير متناغمة، وتوصيات مختلفة من المنظمات المختلفة، وهو ما قد يساهم في تأخير أو رفض قبول التطعيم من جانب النساء الحوامل. نحن نلخص هذه الاختلافات، ونوصي بأن يقوم القادة بالتعاون على مستوى الدولة لوضع توصيات مشتركة. نحن نستخدم المثال الخاص بأستراليا، حيث عملت سلطتان مهنيتان، جنبًا إلى جنب، مع الحكومة، والشركاء في نيوزيلندا معًا، من أجل صياغة رسالة واحدة، ولغة متناغمة، وتوصية موحدة. كان الهدف هو مساعدة أخصائيي الصحة والنساء اللواتي يخططن للحمل، أو الحوامل أو المرضعات حاليًا، لاتخاذ قرار مستنير بشأن تطعيم كوفيد 19. يجب تشجيع المجموعات الاستشارية الوطنية للتحصين، ومنظمات التوليد المهنية، والهيئات الحكومية على تنسيق بياناتها بشأن تطعيم كوفيد 19 للنساء الحوامل والمرضعات، واستخدام لغة وصياغة مماثلة لتحقيق مزيد من الوضوح.新型冠状病毒肺炎疫苗的快速研发和推广为疫情防控工作带来了希望。由于临床试验通常不纳入孕期和哺乳期妇女,所以疫苗接种计划的推行并没有充足的针对孕期妇女的安全和疗效数据。不过,众多专业组织已经意识到在孕期接种新冠疫苗的必要性,并且发布了自己的一套推荐程序。然而,证据的缺乏往往导致不同组织之间的信息混乱、语言不一致和意见分歧,从而有可能导致孕妇推迟或拒绝接种疫苗。我们总结了这些差异并建议各个组织的领导能够在国家层面开展合作以提出意见统一的推荐程序。我们以澳大利亚为例,该国两个专业的权威机构与政府和新西兰的合作伙伴联合提出以一致的语言,传递统一的讯息和推荐程序。其目的在于帮助医护工作者和打算怀孕或者正处于孕期或哺乳期的妇女针对新冠疫苗接种作出明智的决策。我们应鼓励国家免疫咨询小组、专业的产科机构和政府单位统一他们针对孕期和哺乳期妇女接种新冠疫苗方面的陈述,并使用类似的语言和措辞以便更加明确地阐述其意见。.Быстрая разработка и внедрение вакцин против коронавирусной инфекции 2019 года (COVID-19) вселяет надежду в борьбе с этой пандемией. Поскольку беременные и кормящие женщины обычно не участвуют в клинических испытаниях, программа вакцинации была запущена без надлежащих данных о безопасности и эффективности для беременных женщин. Тем не менее многие профессиональные организации признали необходимость применения вакцины против COVID-19 во время беременности и выпустили свой собственный набор рекомендаций. Однако отсутствие доказательств часто приводило к путанице в информационных сообщениях, противоречащим формулировкам и несогласованным рекомендациям в разных организациях, что потенциально способствовало задержке вакцинации или отказу беременных женщин от вакцинации. Авторы приводят сводку этих различий и рекомендуют руководителям сотрудничать на уровне страны для подготовки совместных рекомендаций. В качестве примера использован опыт Австралии, где два профессиональных органа вместе с правительством и партнерами в Новой Зеландии работали над согласованным информированием, едиными формулировками и рекомендациями. Цель заключалась в том, чтобы помочь медицинским работникам и женщинам, планирующим беременность, беременным или кормящим грудью, принять обоснованное решение по поводу вакцинации против COVID-19. Следует поощрять национальные консультативные группы по иммунизации, профессиональные акушерские организации и государственные органы согласовывать свои заявления о вакцинации против COVID-19 для беременных и кормящих женщин, а также использовать схожие формулировки и выражения для обеспечения большей ясности.

Published
2021

5. Yellow Fever Vaccination In EGG-Allergic Children

Author

Kirsten P Perrett, Nicholas Wood, and Ketaki Sharma

Subjects
Male, Microbiology (medical), Pediatrics, medicine.medical_specialty, Adolescent, Ovalbumin, Yellow fever vaccine, Tertiary Care Centers, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, Yellow Fever, medicine, Humans, 030212 general & internal medicine, Child, Egg Hypersensitivity, Adverse effect, biology, business.industry, Vaccination, Yellow Fever Vaccine, Yellow fever, Australia, Infant, medicine.disease, Infectious Diseases, Immunization, Child, Preschool, Egg allergy, Pediatrics, Perinatology and Child Health, biology.protein, Female, business, Anaphylaxis, medicine.drug
Abstract

Yellow fever vaccine contains ovalbumin, and guidelines for vaccination of egg allergic patients vary widely. We present our experience of administering yellow fever vaccine to 11 egg-allergic children, including 3 with anaphylaxis to egg, in 2 Australian tertiary pediatric hospitals. There was variation in the vaccination protocols used; however, all patients were successfully vaccinated and no serious adverse events were reported.

Published
2020
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6. COVID-19 in children. II: Pathogenesis, disease spectrum and management

Author

David Burgner, Emma Goeman, Philip N Britton, Archana Koirala, Daniel K Yeoh, Brendan McMullan, Annaleise R Howard-Jones, Paul Gray, Asha C. Bowen, Danielle Wurzel, Margie Danchin, Nigel W Crawford, Stephanie Kuek, Ketaki Sharma, Peter Hsu, and Shidan Tosif

Subjects
medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Acute infection, Review Article, SARS‐CoV‐2, Pathogenesis, Post-Acute COVID-19 Syndrome, COVID‐19, PIMS‐TS, Pandemic, medicine, Humans, Child, Intensive care medicine, Review Articles, Pandemics, SARS-CoV-2, business.industry, Disease spectrum, COVID-19, Systemic Inflammatory Response Syndrome, virology, Coronavirus, Pediatrics, Perinatology and Child Health, business, management
Abstract

The global disruption of the COVID-19 pandemic has impacted the life of every child either directly or indirectly. This review explores the pathophysiology, immune response, clinical presentation and treatment of COVID-19 in children, summarising the most up-to-date data including recent developments regarding variants of concern. The acute infection with SARS-CoV-2 is generally mild in children, whilst the post-infectious manifestations, including paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) and 'long COVID' in children, are more complex. Given that most research on COVID-19 has focused on adult cohorts and that clinical manifestations, treatment availability and impacts differ markedly in children, research that specifically examines COVID-19 in children needs to be prioritised.

Published
2021

7. Aggregatibacter actinomycetemcomitans osteomyelitis in a 12 year old boy: case report emphasizing the importance of tissue culture, and review of literature

Author

John Whitehall, Poonam Mudgil, Ketaki Sharma, and Iain B Gosbell

Subjects
0301 basic medicine, Microbiology (medical), Male, Pathology, medicine.medical_specialty, medicine.drug_class, 030106 microbiology, Antibiotics, Case Report, Bacteremia, Drug resistance, Cefotaxime, Microbial Sensitivity Tests, Aggregatibacter actinomycetemcomitans, 03 medical and health sciences, 0302 clinical medicine, Medical microbiology, medicine, Humans, Child, Periodontitis, biology, Osteomyelitis, Soft tissue, Amoxicillin, 030206 dentistry, General Medicine, Toes, medicine.disease, biology.organism_classification, Dermatology, Anti-Bacterial Agents, Infectious Diseases
Abstract

Background Aggregatibacter actinomycetemcomitans most commonly causes periodontitis but has been reported to infect heart valves, soft tissue, brain and lungs, and distal bones. Osteomyelitis distal to the jaw is rarely described. Case presentation We report an unusual and rare case of chronic osteomyelitis caused by A. actinomycetemcomitans in the toe of a paediatric patient, and review the available literature. The infection was managed with intravenous antibiotics followed by oral antibiotics. Conclusion This is an unusual presentation of A. actinomycetemcomitans causing chronic osteomyelitis presumed due to nidation in a minimally damaged bone, associated with bacteraemia of an oral commensal. It occurred in the toe, without obvious dental predisposition; associated with minimal clinical disturbance and with muted immune response.

Published
2017

8. Meningococcal vaccines in Australia: a 2019 update

Author

Clayton Chiu, Nicholas Wood, and Ketaki Sharma

Subjects
education.field_of_study, Pediatrics, medicine.medical_specialty, business.industry, Transmission (medicine), Neisseria meningitidis, Population, immunisation, meningitis, Meningococcal vaccine, meningococcal vaccines, medicine.disease, medicine.disease_cause, Meningococcal disease, Article, Vaccination, 03 medical and health sciences, 0302 clinical medicine, Carriage, Medicine, Pharmacology (medical), 030212 general & internal medicine, education, business, Meningitis
Abstract

Invasive meningococcal disease is a rare but serious infection caused by Neisseria meningitidis Serogroup B was the predominant serogroup causing invasive meningococcal disease in Australia until 2015. Serogroup W disease has increased substantially since 2014, and in 2017, serogroups B and W caused similar numbers of invasive disease cases Vaccines against serogroups A, C, W, Y and B are available for anyone who wishes to reduce the risk of meningococcal disease Vaccination is strongly recommended for people in high-risk age or population groups. These are children under 2 years, 15–19 year olds, Aboriginal and Torres Strait Islander children, and people with medical, occupational, behavioural or travel-related risk factors for invasive meningococcal disease Meningococcal ACWY vaccine is funded under the National Immunisation Program for babies aged 12 months. Since April 2019, it has been funded for year 10 students through a school program. There are additional state and territory-based programs for both meningococcal ACWY and meningococcal B vaccines Keywords: immunisation, meningitis, meningococcal vaccines Introduction Neisseria meningitidis is normally a commensal of the nasopharynx. However, it has the potential to invade the mucosa and cause invasive meningococcal disease, which most commonly presents as meningitis, septicaemia or both. There are 13 serogroups of N. meningitidis. Groups A, B, C, W135, Y and X cause the majority of disease.1 Transmission occurs via large-droplet spread or direct contact with oral secretions. Carriage rates vary by population worldwide and by age. Asymptomatic carriage is most common in adolescents and young adults.2 The incidence of invasive disease is highest in 0–4 year olds, especially infants, with a secondary peak in late adolescence and young adults. Invasive meningococcal disease is more common in Aboriginal and Torres Strait Islander children.

Published
2019
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