几内亚比绍健康新生儿早期接种bcg -丹麦或bcg -日本与bcg -俄罗斯:一项随机对照试验

F. Schaltz-Buchholzer, M. Bjerregaard-Andersen, C. B. Øland, C. Golding, Elise Brenno Stjernholm, I. Monteiro, P. Aaby, C. Benn
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引用次数: 21

摘要

背景:卡介苗接种仍然是防治结核病的基石。随机对照试验(RCT)表明,丹麦的bcg降低了全因死亡率,但最近的一项RCT发现俄罗斯的bcg没有效果。观察性研究表明,遗传差异的卡介苗株具有不同的效果。方法在几内亚比绍国立医院进行平行组、开放标签随机对照试验。健康新生儿按1:1随机分为bcg -丹麦组(2851名随机,2840名分析)和bcg -俄罗斯组(2845名随机,2837名分析)。我们假设BCG- denmark会降低发病率(主要结局)和死亡率,同时诱导更多的BCG反应和纯化蛋白衍生物(PPD)反应(次要结局)。试验进行到一半,bcg -丹麦的生产停止,试验继续比较bcg -日本(随机3191例,分析3184例)和bcg -俄罗斯(随机3170例,分析3160例)。通过电话、家访和国立医院收集死亡率和发病率数据,并用cox模型进行评估,提供6周死亡率比(MRRs)和住院发病率比(IRRs)。结果6周龄时,接种bcg -丹麦的新生儿入院140例,接种bcg -俄罗斯的新生儿入院130例,IRR=1.08(95%可信区间:0.84-1.37)。bcg -日本有185人,而bcg -俄罗斯有161人,IRR=1.15(0.93-1.43)。6周死亡率无差异,丹麦/俄罗斯的MRR=1.15 (0.74-1.81);bcg -日本/ bcg -俄罗斯MRR=0.71(0.43-1.19)。BCG-丹麦和BCG-日本比BCG-俄罗斯引起更多的BCG疤痕和PPD反应。结论卡介苗株对发病率无影响。通过传统上被视为成功免疫替代指标的措施,bcg -丹麦和bcg -日本比bcg -俄罗斯更具免疫原性。菌株差异对结核病保护和整体健康的影响值得进一步研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Early vaccination with BCG-Denmark or BCG-Japan versus BCG-Russia to healthy newborns in Guinea-Bissau: A randomized controlled trial.
BACKGROUND Bacille Calmette-Guérin (BCG) vaccination remains a cornerstone against tuberculosis. Randomized controlled trials (RCTs) has demonstrated that BCG-Denmark lowers all-cause mortality, but a recent RCT found no effect of BCG-Russia. Observational studies indicate that the genetically divergent BCG strains have different effects. METHODS Parallel-group, open-label RCT conducted at the National Hospital in Guinea-Bissau. Healthy neonates were randomized 1:1 to BCG-Denmark (2,851 randomized, 2,840 analyzed) versus BCG-Russia (2,845 randomized, 2,837 analyzed). We hypothesized that BCG-Denmark would reduce morbidity (primary outcome) and mortality while inducing more BCG reactions and Purified Protein Derivative (PPD) responses (secondary outcomes). Halfway through the trial, production of BCG-Denmark was halted, and the trial continued comparing BCG-Japan (3,191 neonates randomized, 3,184 analyzed) with BCG-Russia (3,170 randomized, 3,160 analyzed). Mortality and morbidity data were collected by telephone, at home-visits and at the National Hospital and assessed in Cox-models providing 6-week Mortality Rate Ratios (MRRs) and hospitalization Incidence Rate Ratios (IRRs). RESULTS By age 6 weeks, there were 140 admissions among neonates vaccinated with BCG-Denmark and 130 admissions for BCG-Russia, IRR=1.08 (95% Confidence Interval: 0.84-1.37). For BCG-Japan there were 185 admissions versus 161 admissions for BCG-Russia, IRR=1.15 (0.93-1.43). The 6-week mortality did not differ, BCG-Denmark/BCG-Russia MRR=1.15 (0.74-1.81); BCG-Japan/BCG-Russia MRR=0.71 (0.43-1.19). BCG-Denmark and BCG-Japan induced more BCG scars and PPD reactions than BCG-Russia. CONCLUSION BCG strains did not affect morbidity. BCG-Denmark and BCG-Japan were more immunogenic than BCG-Russia by the measures traditionally viewed as surrogates for successful immunization. The implications of strain differences for tuberculosis protection and overall health warrant further study.
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