OBJECTIVES The aim of the study was to estimate the rate of adverse reactions to live BCG Moreau vaccine, manufactured by Biomed in Poland, in severe combined immunodeficiency (SCID) patients. MATERIAL The profiles of 52 SCID patients vaccinated at birth with BCG, hospitalized in Children's Memorial Health Institute, Warsaw (CMHI), in the years 1980-2015 were compared with those of 349 BCG-vaccinated SCID patients from other countries analyzed by Beatriz E. Marciano et al. in a retrospective study (Marciano et al. J Allergy Clin Immunol. 2014;133(4):1134-1141). RESULTS Significantly less disseminated BCG infections (10 out of 52 SCID, 19%) occurred in comparison with Marciano study-119 out of 349, 34% (p = 0.0028), with no death in patients treated with SCID anti-TB drug, except one in lethal condition. In our study, disseminated BCG infection was observed only in SCID with T-B+NK- phenotype and significantly lower NK cell counts (p = 0.0161). NK cells do not influence on the frequency of local BCG reaction. A significantly higher number of hematopoietic stem cells transplantations (HSCT) were performed in CMHI study (p = 0.0001). Anti-TB treatment with at least two medicines was provided. CONCLUSION The BCG Moreau vaccine produced in Poland, with well-documented genetic characteristics, seems to be safer than other BCG substrains used in other regions of the world. Importantly, NK cells seem to play a role in protecting SCID patients against disseminated BCG complications, which NK- SCID patients are more prone to. HSCT and TB therapy could be relevant due to the patients' survival and the fact that they protect against BCG infection.

中文翻译：

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BCG Moreau疫苗的安全性和NK细胞-弥散性BCG感染的双重保护，对52例严重合并免疫功能低下的波兰儿童进行BCG疫苗的回顾性研究。

目的本研究的目的是评估严重合并免疫缺陷症（SCID）患者对波兰Biomed生产的活卡介苗Moreau疫苗的不良反应率。材料将1980-2015年间在华沙儿童纪念健康研究所（CMHI）住院的52例接种卡介苗的SCID患者的概况与来自其他国家的349例接种卡介苗的SCID患者的概况进行了比较（Beatriz E分析）。 Marciano等。在一项回顾性研究中（Marciano et al.J Allergy Clin Immunol.2014; 133（4）：1134-1141）。结果与Marciano研究-349中的119个相比，散布的BCG感染显着较少（52个SCID中的10个，占19％），占34％（p = 0.0028），用SCID抗结核药物治疗的患者没有死亡，除了一名处于致命状态。在我们的研究中 仅在具有T-B + NK-表型且明显降低NK细胞计数的SCID中观察到弥散性BCG感染（p = 0.0161）。NK细胞不影响局部BCG反应的频率。在CMHI研究中进行的造血干细胞移植（HSCT）数量明显增加（p = 0.0001）。提供了至少两种药物的抗结核治疗。结论在波兰生产的BCG Moreau疫苗具有良好的遗传特性，似乎比世界其他地区使用的其他BCG菌株更安全。重要的是，NK细胞似乎在保护SCID患者免受散布的BCG并发症的影响中发挥作用，而NK-SCID患者更容易发生这种情况。HSCT和TB疗法可能因患者的生存以及它们抵抗BCG感染的事实而相关。