Gorbunov M A, Pavlova L I, Titov I A, Bektimirov T A, Selezneva V P, Shitikova O Iu, Mamontova T V, Indikova I N
Tarasevich Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.
Zh Mikrobiol Epidemiol Immunobiol. 1997 Nov-Dec(6):55-8.
The results of field clinical trials of Russian and American yeast vaccines against hepatitis B are presented. The study revealed that both vaccines were faintly reactogenic, safe and exhibited high immunological activity. After the full course of immunization following the schedule 0-1-2 months 92.5% and 97.5% of patients receiving, respectively. Russian vaccine "Combiotech" and American vaccine "H-B-Vax II" were found to have specific antibodies. The maximum effect was registered when the vaccines were introduced according to the schedule 0-1-6 months. Seroconversions were observed in 97.5% and 100% of the vaccinees receiving the Russian and American vaccines respectively, in the latter case the highest antibody level being observed. The use of the vaccines within the prophylactic immunization schedule showed that antibodies to hepatitis B appeared in immunized children in 93-100% of cases. Seroconversion indices and the levels of antibodies to diphtheria, tetanus, poliomyelitis and measles were statistically significant and were the same in children receiving only the vaccines according to the immunization schedule and in children immunized, in addition to these vaccines, against hepatitis B.
介绍了俄罗斯和美国乙型肝炎酵母疫苗的现场临床试验结果。研究表明,两种疫苗的反应原性都较弱,安全且具有高免疫活性。按照0-1-2月的免疫程序完成全程免疫后,分别有92.5%和97.5%接受俄罗斯疫苗“组合生物技术”和美国疫苗“乙肝疫苗II”的患者产生了特异性抗体。按照0-1-6月的程序接种疫苗时效果最佳。分别有97.5%和100%接种俄罗斯和美国疫苗的接种者出现血清转化,在后一种情况下观察到最高抗体水平。在预防性免疫程序中使用这些疫苗表明,93-100%的免疫儿童体内出现了乙肝抗体。血清转化指数以及对白喉、破伤风、脊髓灰质炎和麻疹的抗体水平具有统计学意义,且在仅按照免疫程序接种疫苗的儿童和除这些疫苗外还接种了乙肝疫苗的儿童中相同。