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Protective Efficacy and Pulmonary Immune Response Following Subcutaneous and Intranasal BCG Administration in Mice
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Published on: September 19, 2016

使用结合Mycobacterium leprae/BCG疫苗预防麻风的免疫预防试验:初步结果

J Convit1, C Sampson, M Zúñiga

  • 1Instituto de Biomedicina, Caracas, Venezuela.

Lancet (London, England)
|February 22, 1992
PubMed
概括

这项研究将BCG疫苗单独与BCG与Mycobacterium leprae进行了比较,以预防麻风. 结果显示,添加M. leprae并没有显著的额外保护,但BCG单独提供了相当大的麻风保护.

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科学领域:

  • 免疫学 免疫学 免疫学
  • 传染性疾病 传染性疾病
  • 疫苗学 疫苗学 疫苗学

背景情况:

  • 巴西尔·卡尔梅特-盖林 (BCG) 疫苗用于预防麻风,但提供了不一致的保护.
  • 开发一种更有效的麻风疫苗是全球卫生优先事项.
  • 麻风病例的密切接触者具有最高风险,因此被选为本试验.

研究的目的:

  • 评估BCG疫苗中添加已杀死的Mycobacterium leprae是否与单独BCG相比增强了对麻风的保护.
  • 评估一种新型麻风疫苗候选药物在高风险人群中的有效性.

主要方法:

  • 一项随机对照试验,涉及29113名委内瑞拉的麻风病例接触者.
  • 参与者接受了单独的BCG疫苗或与辐射的Mycobacterium leprae结合的BCG.
  • 随访包括每年进行临床检查,并排除具有先前存在麻风或M. leprae抗原强烈皮肤测试反应的个体.

主要成果:

  • 在超过15万人年的随访中,确认了59例麻风病例 (31例BCG,28例BCG/M. 这里是Leprae).
  • 在预期疫苗效果最高的子组中,BCG/M. 勒普雷的病例比BCG单独的病例少18% (95%CL70%).
  • 追溯分析表明,单独BCG提供了56%的麻风疫苗疗效.

结论:

  • 在最初的5年随访期间,将Mycobacterium leprae添加到BCG中并没有显著改善对麻风的保护.
  • 仅BCG接种疫苗似乎就能对麻风有显著的保护作用.
  • 需要进一步的研究,以充分确定结合BCG/M.的长期疗效. 麻风疫苗. 麻风疫苗.