Purcell R H, Gerin J L
Am J Med Sci. 1975 Sep-Oct;270(2):395-9.
The 22 nm spherical form of hepatitis B surface antigen was purified from the serum or plasma of chronic carriers of the antigen. Antigens of subtypes ayw and adr were individually prepared by isopycnic banding in cesium chloride followed by rate zonal separation in sucrose. Each preparation was stabilized with human serum albumin, and aliquots were inactivated with 1:2000 formalin at 37 C for 96 hours. The potency and immunogenicity of each preparation were determined: both antigenicity and immunogenicity were retained by the preparations following purification and inactivation. Seronegative chimpanzees were vaccinated with the antigen preparations. None of the vaccinated chimpanzees developed evidence of infection with hepatitis B virus during the follow-up period. Twenty-four weeks after vaccination vaccinated and control chimpanzees were inoculated with live hepatitis B virus. Control chimpanzees developed hepatitis associated with HBs Ag seven and nine weeks following challenge. In contrast, none of the chimpanzees vaccinated with HBs Ag developed HBs Ag or hepatitis. Thus, hepatitis B vaccine appeared to be safe and efficacious when tested in chimpanzees.
从乙肝表面抗原慢性携带者的血清或血浆中纯化出22纳米的球形乙肝表面抗原。通过在氯化铯中进行等密度梯度离心，随后在蔗糖中进行速率区带分离，分别制备ayw和adr亚型的抗原。每种制剂用人血清白蛋白进行稳定化处理，等分试样在37℃下用1:2000的福尔马林灭活96小时。测定每种制剂的效价和免疫原性：纯化和灭活后的制剂保留了抗原性和免疫原性。用抗原制剂对血清学阴性的黑猩猩进行免疫接种。在随访期间，没有一只接种疫苗的黑猩猩出现感染乙肝病毒的迹象。接种疫苗24周后，对接种疫苗的黑猩猩和对照黑猩猩接种活乙肝病毒。对照黑猩猩在受到攻击后7周和9周出现与乙肝表面抗原相关的肝炎。相比之下，接种乙肝表面抗原的黑猩猩没有一只出现乙肝表面抗原或肝炎。因此，在黑猩猩身上进行测试时，乙肝疫苗似乎是安全有效的。
