Year: 2023
Type: article
Abstract: BCG vaccination and revaccination are increasingly being considered for the protection of adolescents and adults against tuberculosis and, more broadly, for the off-target protective immunological effects against other infectious and noninfectious diseases. Within an international randomized controlled trial of BCG vaccination in healthcare workers (the BRACE trial), we evaluated the incidence of local and serious adverse events, as well as the impact of previous BCG vaccination on local injection site reactions (BCG revaccination). Prospectively collected data from 99% (5351/5393) of participants in Australia, Brazil, Spain, The Netherlands and the UK was available for analysis. Most BCG recipients experienced the expected self-limiting local injection site reactions (pain, tenderness, erythema, swelling). BCG injection site itch was an additional common initial local symptom reported in 49% of BCG recipients. Compared to BCG vaccination in BCG-naïve individuals, BCG revaccination was associated with increased frequency of mild injection site reactions, as well as earlier onset and shorter duration of erythema and swelling, which were generally self-limiting. Injection site abscess and regional lymphadenopathy were the most common adverse events and had a benign course. Self-resolution occurred within a month in 80% of abscess cases and 100% of lymphadenopathy cases. At a time when BCG is being increasingly considered for its off-target effects, our findings indicate that BCG vaccination and revaccination have an acceptable safety profile in adults.
Authors: Paola Villanueva, Nigel W. Crawford, Mariana Garcia Croda, Simone Collopy, Bruno Araújo Jardim, Tyane de Almeida Pinto Jardim, Helen Marshall, Cristina Prat-Aymerich, Alice Sawka, Ketaki Sharma, Darren Troeman, Ushma Wadia, Adilia Warris, Nicholas Wood, Nicole L. Messina, Nigel Curtis, Laure F. Pittet
Institutions: Royal Children's Hospital, The University of Melbourne, Murdoch Children's Research Institute, Universidade Federal de Mato Grosso do Sul, Universidade do Estado do Rio de Janeiro, Fundação de Medicina Tropical, Women's and Children's Health Network, The University of Adelaide, Universitat Autònoma de Barcelona, Utrecht University, Instituto de Salud Carlos III, University Medical Center Utrecht, Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Royal Adelaide Hospital, Children's Hospital at Westmead, Westmead Hospital, National Centre for Immunisation Research & Surveillance, The Kids Research Institute Australia, University of Exeter, Great Ormond Street Hospital, MRC Centre for Medical Mycology, The University of Sydney, University of Geneva, University Hospital of Geneva
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,134
Funders: National Science Foundation, Bill and Melinda Gates Foundation, Children's Hospital Foundation, Government of South Australia, Australian Government, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, University of Melbourne, Ministry of Health, British Columbia, State Government of Victoria, Minderoo Foundation, Medical Research Council, National Health and Medical Research Council
Awards: Murdoch Childrens Research Institute - to evaluate the potential of the Bacillus Calmette-Guérin vaccine to protect against COVID-19 disease and to further understanding of how Bacillus ..., Exploring the heterologous effect of vaccination, Improving the diagnosis, treatment and prevention of infectious diseases in children, G3660576293, G3816067056, Medical Research Council Centre for Medical Mycology
OpenAlex ID: W4385665147