Horsburgh C R
Department of Epidemiology and Biostatistics, Boston University School of Public Health, Boston, MA 02118, USA.
Clin Infect Dis. 2000 Jun;30 Suppl 3:S213-6. doi: 10.1086/313884.
Although there are no new tuberculosis vaccines currently available, it is possible to estimate the infrastructure needed for efficacy trials of such a vaccine. A randomized, placebo-controlled vaccine strategy for community-wide vaccination of adults is proposed: a large, simple trial with recipients stratified at enrollment by human immunodeficiency virus serologic status and purified protein derivative-skin test status. The outcome, tuberculous disease, would be assessed by community-wide surveillance. Such a trial could be carried out in populations in developed countries where the annual incidence of tuberculous disease is >100 cases per 100,000 persons and in developing countries where the incidence is >400 per 100,000 persons. In developed countries, enrollment of 14,600-80,000 persons would be needed, depending on the initial assumptions; in developing countries, enrollment would be 4400-27,000 persons. Readiness for tuberculosis vaccine efficacy trials will require epidemiological field studies to identify potential trial sites and investment in local diagnostic, surveillance, and data management capabilities.
尽管目前尚无新的结核病疫苗，但仍有可能估算出此类疫苗进行疗效试验所需的基础设施。现提出一种针对成年人进行社区范围疫苗接种的随机、安慰剂对照疫苗策略：开展一项大型简易试验，受试者在入组时按人类免疫缺陷病毒血清学状态和纯化蛋白衍生物皮肤试验状态进行分层。结局指标为结核病，将通过社区范围监测进行评估。此类试验可在发达国家人群中开展，这些国家结核病年发病率>每10万人100例，也可在发展中国家开展，这些国家发病率>每10万人400例。在发达国家，根据初始假设，需要招募14,600 - 80,000人；在发展中国家，招募人数为4400 - 27,000人。开展结核病疫苗疗效试验需要进行流行病学现场研究，以确定潜在的试验地点，并对当地诊断、监测和数据管理能力进行投资。
