Snider D E
Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
Clin Infect Dis. 2000 Jun;30 Suppl 3:S271-5. doi: 10.1086/313872.
Bacille Calmette-Guérin (BCG) vaccines are widely used, even though estimates of efficacy have ranged from zero to 80%. BCG is a relatively safe vaccine, but it can cause disseminated infection, especially in immunocompromised hosts. Thus, the development of a more reliably efficacious and safer vaccine is important to the control of tuberculosis. The testing of any new vaccine in human populations presents a number of ethical challenges that must be addressed. These include (1) the appropriateness of conducting such trials in developing countries; (2) the use of a BCG-vaccinated population as the control group; (3) the provision of tuberculin skin-test screening and preventive therapy to study participants; (4) the involvement of various "communities" in the trial(s); (5) the structure and process of ethical review; (6) establishing an effective method of obtaining informed consent; and (7) the roles and responsibilities of researchers and others in ensuring that trial results are available to the study population after the trial ends.
卡介苗（BCG）疫苗被广泛使用，尽管其效力估计值在0%至80%之间波动。卡介苗是一种相对安全的疫苗，但它可引起播散性感染，尤其是在免疫功能低下的宿主中。因此，开发一种更可靠有效的且更安全的疫苗对于控制结核病很重要。在人群中测试任何新疫苗都存在一些必须解决的伦理挑战。这些挑战包括：（1）在发展中国家开展此类试验是否合适；（2）将接种卡介苗的人群作为对照组；（3）为研究参与者提供结核菌素皮肤试验筛查和预防性治疗；（4）各类“社区”参与试验；（5）伦理审查的结构和流程；（6）建立有效的获得知情同意的方法；以及（7）研究人员和其他人员在确保试验结束后研究人群能够获得试验结果方面的作用和责任。
