Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy
Abstract The reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk facto...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2022-01-01
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| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-021-00421-5 |
| _version_ | 1797427229710352384 |
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| author | Paola Villanueva Ushma Wadia Nigel Crawford Nicole L. Messina Tobias R. Kollmann Michaela Lucas Laurens Manning Peter Richmond Laure F. Pittet Nigel Curtis |
| author_facet | Paola Villanueva Ushma Wadia Nigel Crawford Nicole L. Messina Tobias R. Kollmann Michaela Lucas Laurens Manning Peter Richmond Laure F. Pittet Nigel Curtis |
| author_sort | Paola Villanueva |
| collection | DOAJ |
| description | Abstract The reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk factors for the development of BCG injection site abscess and regional lymphadenopathy. Injection site abscess occurred in 3% of 1387 BCG-vaccinated participants; the majority (34/41, 83%) resolved without treatment. The rate was higher in BCG-revaccinated participants (OR 3.6, 95% CI 1.7–7.5), in whom abscess onset was also earlier (median 16 vs. 27 days, p = 0.008). No participant with an abscess had a positive interferon-gamma release assay. Regional lymphadenopathy occurred in 48/1387 (3%) of BCG-vaccinated participants, with a higher rate in revaccinated participants (OR 2.1, 95% CI 1.1–3.9). BCG-associated lymphadenopathy, but not injection site abscess, was influenced by age and sex. A previous positive tuberculin skin test was not associated with local reactions. The increased risk of injection site abscess or lymphadenopathy following BCG revaccination is relevant to BCG vaccination policy in an era when BCG is increasingly being considered for novel applications. |
| first_indexed | 2024-03-09T08:42:13Z |
| format | Article |
| id | doaj.art-bfc9e101ceab4d0a838dae4f6a03123a |
| institution | Directory Open Access Journal |
| issn | 2059-0105 |
| language | English |
| last_indexed | 2024-03-09T08:42:13Z |
| publishDate | 2022-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj.art-bfc9e101ceab4d0a838dae4f6a03123a2023-12-02T16:40:35ZengNature Portfolionpj Vaccines2059-01052022-01-017111010.1038/s41541-021-00421-5Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathyPaola Villanueva0Ushma Wadia1Nigel Crawford2Nicole L. Messina3Tobias R. Kollmann4Michaela Lucas5Laurens Manning6Peter Richmond7Laure F. Pittet8Nigel Curtis9Department of Paediatrics, The University of MelbourneWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids InstituteDepartment of Paediatrics, The University of MelbourneDepartment of Paediatrics, The University of MelbourneWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids InstituteSchool of Medicine, University of Western AustraliaWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids InstituteWesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids InstituteDepartment of Paediatrics, The University of MelbourneDepartment of Paediatrics, The University of MelbourneAbstract The reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk factors for the development of BCG injection site abscess and regional lymphadenopathy. Injection site abscess occurred in 3% of 1387 BCG-vaccinated participants; the majority (34/41, 83%) resolved without treatment. The rate was higher in BCG-revaccinated participants (OR 3.6, 95% CI 1.7–7.5), in whom abscess onset was also earlier (median 16 vs. 27 days, p = 0.008). No participant with an abscess had a positive interferon-gamma release assay. Regional lymphadenopathy occurred in 48/1387 (3%) of BCG-vaccinated participants, with a higher rate in revaccinated participants (OR 2.1, 95% CI 1.1–3.9). BCG-associated lymphadenopathy, but not injection site abscess, was influenced by age and sex. A previous positive tuberculin skin test was not associated with local reactions. The increased risk of injection site abscess or lymphadenopathy following BCG revaccination is relevant to BCG vaccination policy in an era when BCG is increasingly being considered for novel applications.https://doi.org/10.1038/s41541-021-00421-5 |
| spellingShingle | Paola Villanueva Ushma Wadia Nigel Crawford Nicole L. Messina Tobias R. Kollmann Michaela Lucas Laurens Manning Peter Richmond Laure F. Pittet Nigel Curtis Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy npj Vaccines |
| title | Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy |
| title_full | Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy |
| title_fullStr | Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy |
| title_full_unstemmed | Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy |
| title_short | Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy |
| title_sort | revaccination with bacille calmette guerin bcg is associated with an increased risk of abscess and lymphadenopathy |
| url | https://doi.org/10.1038/s41541-021-00421-5 |
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