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血源乙型肝炎(HB)疫苗免疫3针后,90％以上接种者产生抗体,唯价格昂贵,且以感染性血浆为原料而未能推广。1981年,HBsAg在酿酒酵母中表达成功。1986年重组HB疫苗获准使用。在19个国家58项研究的5664名对象(至少接受1剂,共15 308剂)中,未见疫苗所致严重反应,局部有轻度疼痛、红肿,偶有发热。在另一项13 836人临床观察中,接种40 140剂重组HB疫苗,结果相似。接种部位轻度疼痛持续1～2天的发生率为23％,硬结8％;全身反应:疲劳15％,头痛9％,但未见与接种直接相关的重要临床副作用。在450万剂售后监测中,仅307起副反应,包括恶心、皮疹、头痛、发热、
After 3 doses of HB vaccine were immunized, more than 90% of the vaccinates produced antibodies, which were expensive and infective plasma could not be used for promotion. In 1981, HBsAg was successfully expressed in Saccharomyces cerevisiae. The recombinant HB vaccine was approved for use in 1986. In 5664 subjects from 58 studies in 19 countries (receiving at least one dose of 15 308 agents), no serious reaction was observed with the vaccine, with mild local pain, swelling and occasional fever. In another 13,836 clinical observations, 40 140 doses of recombinant HB vaccine were inoculated with similar results. The incidence of mild pain at the site of inoculation was 23% for 1 to 2 days and 8% for induration; systemic reactions were 15% for fatigue and 9% for headaches, but no significant clinical side-effects were directly associated with vaccination. Of the 4.5 million doses of aftermarket monitoring, only 307 side effects, including nausea, rash, headache, fever,