Coutinho R A, Lelie N, Albrecht-Van Lent P, Reerink-Brongers E E, Stoutjesdijk L, Dees P, Nivard J, Huisman J, Reesink H W
Br Med J (Clin Res Ed). 1983 Apr 23;286(6374):1305-8. doi: 10.1136/bmj.286.6374.1305.
The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised placebo controlled double blind trial. At the trial end point (21.5 months), 17 hepatitis B virus infections had occurred in vaccinated subjects (attack rate 4.8%) and 56 in subjects receiving a placebo (attack rate 23.8%). This reduction in the incidence of hepatitis B virus infections in vaccinated subjects was highly significant (p less than 0.0001). Two months after the first injection 72.3% of the vaccinated subjects had formed antibodies against hepatitis B surface antigen, and this percentage increased to 89% at four months. Maximum anti-HBs titres were reached five months after the first vaccination, the geometric mean titre being 107.6 mIU. Even vaccinated subjects with a low antibody response (greater than or equal to 1 and less than 10 mIU) were found to be protected from HBsAg-positive infections. The vaccine had no serious side effects.
在一项随机、安慰剂对照双盲试验中，对800名易感染的同性恋高危男性组成的群体，研究了一种含3微克乙肝表面抗原（HBsAg）的热灭活乙肝疫苗的疗效。在试验终点（21.5个月）时，接种疫苗的受试者中发生了17例乙肝病毒感染（发病率4.8%），接受安慰剂的受试者中有56例（发病率23.8%）。接种疫苗的受试者中乙肝病毒感染发病率的降低非常显著（p<0.0001）。首次注射后两个月，72.3%的接种疫苗受试者产生了抗乙肝表面抗原抗体，四个月时这一比例增至89%。首次接种疫苗五个月后达到最大抗-HBs滴度，几何平均滴度为107.6 mIU。即使是抗体反应较低（大于或等于1且小于10 mIU）的接种疫苗受试者，也被发现可免受HBsAg阳性感染。该疫苗无严重副作用。
