Fletcher Helen, McShane Helen
University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford OX3 7LJ, UK.
Expert Opin Emerg Drugs. 2006 May;11(2):207-15. doi: 10.1517/14728214.11.2.207.
There is an urgent need to develop more effective tuberculosis vaccines as chemotherapy and Bacille Calmette-Guérin (BCG) have failed to control the current epidemic. BCG does have some protective effect in childhood, so using a second vaccine to boost BCG would be the most ethical and logistically feasible strategy. The cost of tuberculosis efficacy trials will be high and return on investment into the development of a tuberculosis vaccine will be low. Incentives such as orphan drug status could encourage industrial interest. As more vaccines enter into early clinical trials, there is an urgent need for the identification of correlates of protection to aid decisions about which vaccines should go forward into efficacy testing. Research efforts that focus on reducing the cost and risk of conducting clinical trials will be of direct benefit to tuberculosis vaccine development.
由于化疗和卡介苗（BCG）未能控制当前的结核病流行，因此迫切需要开发更有效的结核病疫苗。卡介苗在儿童期确实有一定的保护作用，所以使用第二种疫苗来增强卡介苗的效果将是最符合伦理且在后勤方面可行的策略。结核病疗效试验的成本将很高，而投资开发结核病疫苗的回报将很低。诸如孤儿药地位等激励措施可能会激发产业界的兴趣。随着越来越多的疫苗进入早期临床试验，迫切需要确定保护相关性，以帮助决定哪些疫苗应进入疗效测试阶段。专注于降低进行临床试验的成本和风险的研究工作将直接有利于结核病疫苗的开发。
