Romanova L N, Polyushkina G S
Dev Biol Stand. 1978;40:209-13.
Tissue culture rabies vaccines are essentially new preparations intended for prophylaxis and treatment of rabies. However, the methods used for their testing are mostly the same as those used for rabies vaccines prepared from brain tissue. Therefore, it is extremely important to develop and standardize methods for testing tissue culture rabies vaccines. The main criteria for the evaluation of Vnukovo-32 production strain have been formulated. The strain has been characterized in pathomorphological studies; the degree and nature of lesions produced in animal brain tissue by various doses of antigen and different routes of inoculation have been determined. In order to ensure the specific innocuity of rabies vaccines inactivated preparations are produced. However, with the current methods of inactivation (treatment with beta-propiolactone or phenol, ultraviolet irradiation and others) some viral particles may occasionally remain active. Besides, reparative processes may possibly occur in utraviolet-irradiated viruses. The penetration of even sublethal doses of live virus into the body is highly undesirable, since under certain conditions the long-term harbouring of the live viral particle may result in the development of various pathological conditions. In order to reveal minimum amounts of live virus in the preparation a method of additional passages in a susceptible cell system using the fluorescent antibody technique has been developed. By this method it has been possible to detect the presence of live virus in 10 out of 51 lots of vaccine under test.
组织培养狂犬病疫苗本质上是用于狂犬病预防和治疗的新制剂。然而，用于检测它们的方法大多与用于脑组织制备的狂犬病疫苗的检测方法相同。因此，开发和规范组织培养狂犬病疫苗的检测方法极其重要。已经制定了评估伏努科沃-32生产毒株的主要标准。该毒株已在病理形态学研究中得到表征；已确定不同剂量抗原和不同接种途径在动物脑组织中产生的病变程度和性质。为确保狂犬病疫苗的特异性无害性，制备了灭活制剂。然而，使用目前的灭活方法（用β-丙内酯或苯酚处理、紫外线照射等），一些病毒颗粒偶尔可能仍保持活性。此外，紫外线照射的病毒可能会发生修复过程。即使是亚致死剂量的活病毒进入体内也是非常不可取的，因为在某些情况下，活病毒颗粒的长期存留可能导致各种病理状况的发生。为了检测制剂中活病毒的最小含量，已开发出一种在易感细胞系统中使用荧光抗体技术进行额外传代的方法。通过这种方法，在51批受试疫苗中有10批检测到了活病毒的存在。
