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将铝盐和单磷脂A复合物(SBAS4)这一新佐剂与重组HBsAg构成一种新型乙型肝炎疫苗(SBAS4-HBV疫苗).为评价这一疫苗的安全性和免疫原性,作者将27名19～25岁的健康志愿者分为试验组和对照组,按0、1及6月程序分别接种SBAS4-HBV疫苗和市售重组HB疫苗(Engerix-B),剂量均为每剂1ml,含重组HBsAg 20μg,铝盐0.5mg.于接种第1剂后7、15、30、37、45、60、90、180、210和365天静脉采血,测定抗-HBs滴度,并于0、60、180、210和365天静脉采血,进行体外HBsAg特异性淋巴细胞增殖反应,以测定细胞介导免疫应答.接种后两组局部和全身不良反应均轻
A new hepatitis B vaccine (SBAS4-HBV vaccine), a new adjuvant of aluminum salt and phospholipid A complex (SBAS4) and recombinant HBsAg, was constructed to evaluate the safety and immunogenicity of this vaccine Twenty-seven healthy volunteers aged 19-25 years were divided into experimental group and control group. The SBAS4-HBV vaccine and the commercially available recombinant HB vaccine (Engerix-B) were inoculated respectively according to the procedures of 0, 1, and 6 months, , Containing 20μg of recombinant HBsAg and 0.5mg of aluminum salt.The blood samples were collected at 7, 15, 30, 37, 45, 60, 90, 180, 210 and 365 days after inoculation of the first dose, , 60, 180, 210 and 365 days venous blood for in vitro HBsAg-specific lymphocyte proliferation response to determine the cell-mediated immune response after inoculation of both local and systemic adverse reactions were light