Szmuness W, Stevens C E, Harley E J, Zang E A, Oleszko W R, William D C, Sadovsky R, Morrison J M, Kellner A
N Engl J Med. 1980 Oct 9;303(15):833-41. doi: 10.1056/NEJM198010093031501.
We assessed the efficacy of an inactivated hepatitis B vaccine in a placebo-controlled, randomized, double-blind trial in 1083 homosexual men known to be at high risk for hepatitis B virus infection. The vaccine was found to be safe and the incidence of side effects was low. Within two months, 77% of the vaccinated persons had high levels of antibody against the hepatitis B surface antigen. This rate increased to 96% after the booster dose and remained essentially unchanged for the duration of the trial. For the first 18 months of follow-up, hepatitis B or subclinical infection developed in only 1.4 to 3.4% of the vaccine recipients as compared with 18 to 27% of placebo recipients (P < 0.0001). The reduction of incidence in the vaccinees was as high as 92.3%; none of the vaccinees with a detectable immune response to the vaccine had clinical hepatitis B or asymptomatic antigenemia. A significant reduction of incidence was already seen within 75 days after randomization; this observation suggests that the vaccine may be efficacious even when given after exposure.
我们在一项安慰剂对照、随机、双盲试验中评估了一种灭活乙型肝炎疫苗的疗效，该试验涉及1083名已知感染乙型肝炎病毒风险较高的男同性恋者。结果发现该疫苗安全，副作用发生率低。在两个月内，77%的接种者产生了高水平的乙型肝炎表面抗原抗体。加强剂量后这一比例增至96%，并在试验期间基本保持不变。在随访的前18个月中，仅1.4%至3.4%的疫苗接种者发生了乙型肝炎或亚临床感染，而安慰剂组接种者的这一比例为18%至27%（P<0.0001）。疫苗接种者的发病率降低高达92.3%；对疫苗有可检测免疫反应的疫苗接种者均未发生临床乙型肝炎或无症状抗原血症。随机分组后75天内就已观察到发病率显著降低；这一观察结果表明，即使在接触后接种疫苗也可能有效。
