Karelin V P, Babaeva E E, Gubenko E F, Kaulen D K, Zhdanov V M
J Med Virol. 1980;5(4):331-41. doi: 10.1002/1096-9071(1980)5:4<331::aid-jmv1890050410>3.0.co;2-3.
A method for obtaining a subunit inactivated vaccine preparation from the 22-nm particles of HBsAg is proposed. For inactivation of the residual infectious hepatitis B virus (HBV) the preparations were successively treated with 1% sodium dodecyl sulfate (SDS) and nucleases. In addition, thermal denaturation and ultraviolet irradiation of HBV DNA were used. As a control the biologic activity of a reference virus (SV40) was tested after the same treatment. The effectiveness of DNA inactivation was monitored by adding 3H-thymidine labeled reference virus to the vaccine preparations. The purified and inactivated HBsAg was adsorbed on Al2O3. Antigenicity was calculated on the basis of the determination of antibody in guinea pigs immunized with various doses of the vaccine, and the release of 125I- HBsAg from blood and kidneys in immunized and control mice was analyzed. Possible methods of inactivation and control of HBV vaccine is discussed.
提出了一种从乙肝表面抗原（HBsAg）的22纳米颗粒中获取亚单位灭活疫苗制剂的方法。为使残留的传染性乙型肝炎病毒（HBV）失活，制剂先后用1%十二烷基硫酸钠（SDS）和核酸酶处理。此外，还采用了对HBV DNA进行热变性和紫外线照射的方法。作为对照，在相同处理后检测了参考病毒（SV40）的生物活性。通过向疫苗制剂中添加3H-胸腺嘧啶标记的参考病毒来监测DNA失活的有效性。纯化并灭活的HBsAg吸附在氧化铝上。根据用不同剂量疫苗免疫的豚鼠中抗体的测定计算抗原性，并分析免疫小鼠和对照小鼠血液及肾脏中125I-HBsAg的释放情况。讨论了灭活和控制HBV疫苗的可能方法。
