LARGE-SCALE EFFICACY TRIALS OF HEPATITIS-B VACCINES IN THE USA - BASELINE DATA AND PROTOCOLS
LARGE-SCALE EFFICACY TRIALS OF HEPATITIS-B VACCINES IN THE USA - BASELINE DATA AND PROTOCOLS
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DOI：
10.1002/jmv.1890040411
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发表时间：
1979-01-01
影响因子：
12.7
通讯作者：
SZMUNESS, W
中科院分区：
文献类型：
--
作者：
SZMUNESS, W
描述了3项安慰剂对照、随机、双盲临床试验的方案，以评估灭活乙型肝炎病毒（HBV）疫苗在透析患者和工作人员以及男性同性恋者中的疗效。根据预计的对照组乙型肝炎病毒的发病率、疫苗效力和随访失踪率，需要对3000多名参与者进行至少12个月的随访才能证明疫苗的效力。本文回顾了这些人群的长期基线研究结果。
Protocols of 3 placebo-controlled, randomized, double-blind clinical trials to assess the efficacy of an inactivated hepatitis B virus (HBV) vaccine in dialysis patients and staff and in male homosexuals are described. Based on the projected attack rates of HBV in the controls, vaccine efficacy and rates of loss to follow-up, over 3000 participants followed for at least 12 mo. are required to prove the efficacy of the vaccine. The results of long-term baseline studies in these populations are reviewed.