Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Infectious Diseases Research Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Infectious Diseases Unit, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia; Population Allergy Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia; Department of Allergy and Immunology, Royal Children's Hospital Melbourne, Parkville, Victoria, Australia.
Vaccine. 2021 May 12;39(20):2736-2745. doi: 10.1016/j.vaccine.2020.08.016. Epub 2021 Mar 31.
Revaccination with Bacillus Calmette-Guérin (BCG) vaccine is not generally recommended due to a lack of proven efficacy of repeat doses for protection against tuberculosis. However, there is a growing interest in the use of BCG vaccine for its 'off-target' effects which might involve revaccination. We did a systematic review of the safety of BCG revaccination.
MEDLINE (1946 to March 2020) and the BCG World Atlas (updated 2017) were searched, limiting to studies of BCG administration by the intradermal or percutaneous route. Adverse events as well as patient and vaccine characteristics were reviewed.
The search identified 388 articles, of which 24 met the inclusion criteria. These reported 22 studies comprising eight randomised trials, four case-control studies, four observational studies and six case series or reports. Overall, there was evidence for a small increase in the rate of mild local and systemic reactions. No serious adverse events were reported in immunocompetent individuals.
Evidence to date suggests that revaccination with BCG vaccine carries minimal risk. Future studies of BCG vaccine for novel applications should report adverse event data stratified by prior BCG vaccination status.
由于重复剂量的卡介苗（BCG）疫苗在预防结核病方面的疗效缺乏证据，因此通常不建议进行再接种。然而，人们对 BCG 疫苗的“非靶向”作用越来越感兴趣，这些作用可能涉及再接种。我们对 BCG 再接种的安全性进行了系统评价。
我们对 MEDLINE（1946 年至 2020 年 3 月）和 BCG 世界地图集（2017 年更新）进行了检索，仅限于皮内或皮外途径给予 BCG 的研究。我们回顾了不良反应以及患者和疫苗的特征。
搜索共确定了 388 篇文章，其中 24 篇符合纳入标准。这些文章报告了 22 项研究，其中包括 8 项随机试验、4 项病例对照研究、4 项观察性研究和 6 项病例系列或报告。总的来说，有证据表明轻度局部和全身反应的发生率略有增加。在免疫功能正常的个体中，没有报告严重的不良事件。
目前的证据表明，BCG 疫苗再接种的风险很小。未来针对新型应用的 BCG 疫苗研究应报告按既往 BCG 接种状况分层的不良事件数据。
