Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy

Paola Villanueva; Ushma Wadia; Nigel Crawford; Nicole L Messina; Tobias R Kollmann; Michaela Lucas; Laurens Manning; Peter Richmond; Laure F Pittet; Nigel Curtis

doi:10.1038/s41541-021-00421-5

Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy

NPJ Vaccines. 2022 Jan 14;7(1):6. doi: 10.1038/s41541-021-00421-5.

Authors

Paola Villanueva^{1

2

3}, Ushma Wadia⁴, Nigel Crawford^{5

6

7

8}, Nicole L Messina^{5

6}, Tobias R Kollmann⁴, Michaela Lucas^{9

10

11

12}, Laurens Manning^{4

9

13}, Peter Richmond^{4

9

11}, Laure F Pittet^{5

6

14}, Nigel Curtis^{15

16

17}

Affiliations

¹ Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia. paola.villanueva@rch.org.au.
² Infection and Immunity, Murdoch Children's Research Institute, Parkville, VIC, Australia. paola.villanueva@rch.org.au.
³ Department of General Medicine, Royal Children's Hospital, Melbourne, Parkville, VIC, Australia. paola.villanueva@rch.org.au.
⁴ Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, WA, Australia.
⁵ Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia.
⁶ Infection and Immunity, Murdoch Children's Research Institute, Parkville, VIC, Australia.
⁷ Department of General Medicine, Royal Children's Hospital, Melbourne, Parkville, VIC, Australia.
⁸ Immunisation Service, Royal Children's Hospital Melbourne, Parkville, VIC, Australia.
⁹ School of Medicine, University of Western Australia, Perth, WA, Australia.
¹⁰ Department of Immunology, Sir Charles Gairdner Hospital, Perth, WA, Australia.
¹¹ Departments of Immunology and General Paediatrics, Perth Children's Hospital, Perth, WA, Australia.
¹² Department of Immunology, Pathwest, QE2 Medical Centre, Perth, WA, Australia.
¹³ Department of Infectious Diseases, Fiona Stanley Hospital, Perth, WA, Australia.
¹⁴ Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, VIC, Australia.
¹⁵ Department of Paediatrics, The University of Melbourne, Parkville, VIC, Australia. nigel.curtis@rch.org.au.
¹⁶ Infection and Immunity, Murdoch Children's Research Institute, Parkville, VIC, Australia. nigel.curtis@rch.org.au.
¹⁷ Infectious Diseases, Royal Children's Hospital Melbourne, Parkville, VIC, Australia. nigel.curtis@rch.org.au.

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.

Abstract

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