Safety of BCG vaccination and revaccination in healthcare workers.

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dc.contributor.authorVillanueva, P.
dc.contributor.authorCrawford, N.W.
dc.contributor.authorGarcia Croda, M.
dc.contributor.authorCollopy, S.
dc.contributor.authorAraújo Jardim, B.
dc.contributor.authorde Almeida Pinto Jardim, T.
dc.contributor.authorMarshall, H.
dc.contributor.authorPrat-Aymerich, C.
dc.contributor.authorSawka, A.
dc.contributor.authorSharma, K.
dc.contributor.authorTroeman, D.
dc.contributor.authorWadia, U.
dc.contributor.authorWarris, A.
dc.contributor.authorWood, N.
dc.contributor.authorMessina, N.L.
dc.contributor.authorCurtis, N.
dc.contributor.authorPittet, L.F.
dc.date.issued2023
dc.description.abstractBCG 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.
dc.description.statementofresponsibilityPaola 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, and Laure F. Pittet
dc.identifier.citationHuman Vaccines and Immunotherapeutics, 2023; 19(2):2239088-2239088
dc.identifier.doi10.1080/21645515.2023.2239088
dc.identifier.issn2164-5515
dc.identifier.issn2164-554X
dc.identifier.orcidMarshall, H. [0000-0003-2521-5166]
dc.identifier.urihttps://hdl.handle.net/2440/139231
dc.language.isoen
dc.publisherTaylor & Francis
dc.relation.granthttp://purl.org/au-research/grants/nhmrc/GNT1197117
dc.rights© 2023 The Author(s). Published with license by Taylor & Francis Group, LLC. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The terms on which this article has been published allow the posting of the Accepted Manuscript in a repository by the author(s) or with their consent.
dc.source.urihttps://doi.org/10.1080/21645515.2023.2239088
dc.subjectBCG
dc.subjecthealthcare workers
dc.subjectrevaccination
dc.subjectvaccine adverse events
dc.subject.meshHumans
dc.subject.meshAbscess
dc.subject.meshBCG Vaccine
dc.subject.meshImmunization, Secondary
dc.subject.meshVaccination
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshHealth Personnel
dc.subject.meshInjection Site Reaction
dc.titleSafety of BCG vaccination and revaccination in healthcare workers.
dc.typeJournal article
pubs.publication-statusPublished

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