TY - JOUR
T1 - Factors influencing scar formation following Bacille Calmette-Guérin (BCG) vaccination
AU - Villanueva, Paola
AU - Crawford, Nigel W.
AU - Croda, Mariana Garcia
AU - Collopy, Simone
AU - Jardim, Bruno Araújo
AU - de Almeida Pinto Jardim, Tyane
AU - Manning, Laurens
AU - Lucas, Michaela
AU - Marshall, Helen
AU - Prat-Aymerich, Cristina
AU - Sawka, Alice
AU - Sharma, Ketaki
AU - Troeman, Darren
AU - Wadia, Ushma
AU - Warris, Adilia
AU - Wood, Nicholas
AU - Messina, Nicole L.
AU - Curtis, Nigel
AU - Pittet, Laure F.
N1 - Funding Information:
We thank the BRACE trial participants for making this study possible. We also thank the researchers involved in establishing the BRACE trial (see Supplemental Material 4 for the BRACE trial commenced in Australia), in particular: Ms. Veronica Abruzzo, Ms. Sonja Elia, Mr. Richard Hall, Ms. Casey Goodall, Dr. Ellie McDonald, Ms. Ann Krastev, Dr. Samantha Bannister, Ms. Grace Gell, Dr. Wendy Norton, Dr. Joyce Chan, A/Prof. Peter Richmond, Prof. Tobias Kollmann, Dr. Susan Hermann, Ms. Erin Latkovic, Ms. Michelle England, Dr. Roberto Oliveira, Dr. Estela Carvalho, Dr. Helen Catterick, Ms. Glauce Dos Santos, Ms. Catriona Doran, Dr. Alison Gifford, Dr. Telma Goldenberg, Dr. Christina Guo, Dr. Georgina Newman, Dr. Ligia Olivio, Dr. Lorrie Symons, Dr. Niki Tan, Dr. Laura Tate, Dr. Tina Zhou. The Murdoch Children's Research Institute (MCRI) leads the BRACE trial across five countries. It is supported by the Victorian Government's Operational Infrastructure Support Programme. The trial is also supported by the Bill & Melinda Gates Foundation [INV-017302], the Minderoo Foundation [COV-001], Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation [2020–1263 BRACE Trial], Health Services Union NSW, the Peter Sowerby Foundation, the Ministry of Health Government of South Australia is in Australia, the NAB Foundation, the Calvert-Jones Foundation is in Australia, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare and individual donors. The sponsors had no role in the collection, analysis and interpretation of data or in the preparation, review or approval of the manuscript. P.V. is supported by the Australian Government Research Training Programme Scholarship provided by the Australian Commonwealth Government and the University of Melbourne, and an MCRI Ph.D. Top-Up Scholarship. L.F.P. is supported by the Swiss National Science Foundation is based in Switzerland [Early Postdoc Mobility Grant, P2GEP3_178155]. N.C. is supported by a National Health and Medical Research Council Investigator Grant [GNT1197117].
Funding Information:
We thank the BRACE trial participants for making this study possible. We also thank the researchers involved in establishing the BRACE trial (see Supplemental Material 4 for the BRACE trial commenced in Australia), in particular: Ms. Veronica Abruzzo, Ms. Sonja Elia, Mr. Richard Hall, Ms. Casey Goodall, Dr. Ellie McDonald, Ms. Ann Krastev, Dr. Samantha Bannister, Ms. Grace Gell, Dr. Wendy Norton, Dr. Joyce Chan, A/Prof. Peter Richmond, Prof. Tobias Kollmann, Dr. Susan Hermann, Ms. Erin Latkovic, Ms. Michelle England, Dr. Roberto Oliveira, Dr. Estela Carvalho, Dr. Helen Catterick, Ms. Glauce Dos Santos, Ms. Catriona Doran, Dr. Alison Gifford, Dr. Telma Goldenberg, Dr. Christina Guo, Dr. Georgina Newman, Dr. Ligia Olivio, Dr. Lorrie Symons, Dr. Niki Tan, Dr. Laura Tate, Dr. Tina Zhou. The Murdoch Children's Research Institute (MCRI) leads the BRACE trial across five countries. It is supported by the Victorian Government's Operational Infrastructure Support Programme. The trial is also supported by the Bill & Melinda Gates Foundation [INV-017302], the Minderoo Foundation [COV-001], Sarah and Lachlan Murdoch, the Royal Children's Hospital Foundation [2020–1263 BRACE Trial], Health Services Union NSW, the Peter Sowerby Foundation, the Ministry of Health Government of South Australia is in Australia, the NAB Foundation, the Calvert-Jones Foundation is in Australia, the Modara Pines Charitable Foundation, the UHG Foundation Pty Ltd, Epworth Healthcare and individual donors. The sponsors had no role in the collection, analysis and interpretation of data or in the preparation, review or approval of the manuscript. P.V. is supported by the Australian Government Research Training Programme Scholarship provided by the Australian Commonwealth Government and the University of Melbourne, and an MCRI Ph.D. Top-Up Scholarship. L.F.P. is supported by the Swiss National Science Foundation is based in Switzerland [Early Postdoc Mobility Grant, P2GEP3_178155]. N.C. is supported by a National Health and Medical Research Council Investigator Grant [GNT1197117].
Publisher Copyright:
© 2023 The Authors
PY - 2023/4
Y1 - 2023/4
N2 - The prevalence of scar formation following Bacille Calmette-Guérin (BCG) vaccination varies globally. The beneficial off-target effects of BCG are proposed to be stronger amongst children who develop a BCG scar. Within an international randomised trial (‘BCG vaccination to reduce the impact of coronavirus disease 2019 (COVID-19) in healthcare workers’; BRACE Trial), this nested prospective cohort study assessed the prevalence of and factors influencing scar formation, as well as participant perception of BCG scarring 12 months following vaccination. Amongst 3071 BCG-recipients, 2341 (76%) developed a BCG scar. Scar prevalence was lowest in Spain and highest in UK. Absence of post-injection wheal (OR 0.4, 95%CI 0.2–0.9), BCG revaccination (OR 1.7, 95%CI 1.3–2.0), female sex (OR 2.0, 95%CI 1.7–2.4), older age (OR 0.4, 95%CI 0.4–0.5) and study country (Brazil OR 1.6, 95%CI 1.3–2.0) influenced BCG scar prevalence. Of the 2341 participants with a BCG scar, 1806 (77%) did not mind having the scar. Participants more likely to not mind were those in Brazil, males and those with a prior BCG vaccination history. The majority (96%) did not regret having the vaccine. Both vaccination-related (amenable to optimisation) and individual-related factors affected BCG scar prevalence 12 months following BCG vaccination of adults, with implications for maximising the effectiveness of BCG vaccination.
AB - The prevalence of scar formation following Bacille Calmette-Guérin (BCG) vaccination varies globally. The beneficial off-target effects of BCG are proposed to be stronger amongst children who develop a BCG scar. Within an international randomised trial (‘BCG vaccination to reduce the impact of coronavirus disease 2019 (COVID-19) in healthcare workers’; BRACE Trial), this nested prospective cohort study assessed the prevalence of and factors influencing scar formation, as well as participant perception of BCG scarring 12 months following vaccination. Amongst 3071 BCG-recipients, 2341 (76%) developed a BCG scar. Scar prevalence was lowest in Spain and highest in UK. Absence of post-injection wheal (OR 0.4, 95%CI 0.2–0.9), BCG revaccination (OR 1.7, 95%CI 1.3–2.0), female sex (OR 2.0, 95%CI 1.7–2.4), older age (OR 0.4, 95%CI 0.4–0.5) and study country (Brazil OR 1.6, 95%CI 1.3–2.0) influenced BCG scar prevalence. Of the 2341 participants with a BCG scar, 1806 (77%) did not mind having the scar. Participants more likely to not mind were those in Brazil, males and those with a prior BCG vaccination history. The majority (96%) did not regret having the vaccine. Both vaccination-related (amenable to optimisation) and individual-related factors affected BCG scar prevalence 12 months following BCG vaccination of adults, with implications for maximising the effectiveness of BCG vaccination.
KW - BCG scar
KW - BCG vaccine
KW - Vaccination technique
KW - Vaccine safety
UR - http://www.scopus.com/inward/record.url?scp=85153583286&partnerID=8YFLogxK
U2 - 10.1016/j.heliyon.2023.e15241
DO - 10.1016/j.heliyon.2023.e15241
M3 - Article
C2 - 37113782
AN - SCOPUS:85153583286
SN - 2405-8440
VL - 9
JO - Heliyon
JF - Heliyon
IS - 4
M1 - e15241
ER -
