Gorbunov M A, Pavlova L I, Noslova A V, Ikoev V N, Bektimirov T A, Voĭtenkov M M, Belyshev B P, Borisenko I A, Titov I A
Vopr Virusol. 1993 Sep-Dec;38(5):216-8.
Controlled epidemiological studies were carried out to evaluate two recombinant vaccines against hepatitis B of Cuban and Belgian production by the parameters of reactogenicity, safety and antigenic activity. Two groups of adult subjects (n = 73 each) and two groups of children (n = 30 each) were selected among those free from hepatitis B markers carrier state. The adults were given both preparations in a dose of 20 micrograms at intervals of 0-1-4 months, and the children received 10 micrograms at 0-1-2 months. The comparative studies showed both vaccines to be poorly reactogenic, safe and inducing anti-Hns in 80-100% of triply vaccinated subjects in titres within 100-500 IU. No statistically significant differences in the examined parameters were found in the two preparations tested.
开展了对照流行病学研究，以通过反应原性、安全性和抗原活性参数评估两种古巴生产和比利时生产的重组乙型肝炎疫苗。在无乙型肝炎标志物携带状态的人群中挑选了两组成人受试者（每组n = 73）和两组儿童（每组n = 30）。成人按0-1-4月的间隔给予两种制剂，剂量为20微克，儿童在0-1-2月接受10微克。比较研究表明，两种疫苗的反应原性均较差、安全，并且在80%-100%的三次接种受试者中诱导产生100-500 IU滴度的抗-Hns。在所测试的两种制剂中，未发现所检查参数有统计学上的显著差异。
