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为了比较两种剂量[10μg(S10)和 40μg(S40)]市售重组S亚单位乙型肝炎(HB)疫苗和10μg前S1、S2和S亚单位混合颗粒的重组疫苗(MPV)在健康无免疫应答成人中诱生的保护性抗体,作者选取20～64岁对至少三次肌肉注射血源性或酵母重组HB疫苗的基础免疫无应答的成人为受试对象.受试者在年龄、体重、性别、研究前HB疫苗接种次数方面无差异,将受试对象随机分为三组,分别于 0、1、2月接受 MPV、S10或S40疫苗.疫苗接种后的不良反应与以往文献报道一致.发热和注射部位发红、疼痛为最常见反应,分别为5.5%和23%～55%.各组间不良反应率无统计学差别.
To compare the efficacy of recombinant vaccines (MPV) at two doses [10 μg (S10) and 40 μg (S40)] of commercially available recombinant S subunit Hepatitis B (HB) vaccine and 10 μg of pre-S1, S2 and S subunit mixed particles in healthy Immune response induced by adult protective antibodies, the authors selected from 20 to 64 years of at least three intramuscular injection of blood or yeast recombinant HB vaccine-based non-immune response of adults as subjects in subjects with age, weight, Gender, pre-study HB vaccination number of no difference, the subjects were randomly divided into three groups, respectively, in January, February and February to receive MPV, S10 or S40 vaccine.After vaccination, adverse reactions reported in the literature. Fever and injection site redness, pain is the most common reaction, respectively, 5.5% and 23% to 55% .There was no significant difference in adverse reactions among the groups.