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目的观察国产冻干人用狂犬病纯化疫苗(Vero细胞微载体)的接种反应和免疫原性。方法在山东省高密市按临床方案的入选标准选取年龄在10~60岁,身体健康,无犬伤史、狂犬病疫苗接种史及该疫苗接种禁忌证的志愿者,分Ⅰ、Ⅱ、Ⅲ期进行临床试验,按照免疫程序,接种国产冻干人用狂犬病疫苗,Ⅱ期临床试验以进口同类疫苗作为对照,进行接种反应和免疫原性观察。结果试验组疫苗接种后,不良反应发生率低,以人数计Ⅰ、Ⅱ、Ⅲ期不良反应发生率分别为6.1%、7.8%和7.7%,未见中、强反应,反应均为注射部位疼痛,不伴有局部红肿和硬结,为局部弱反应,未出现体温升高等全身反应,72 h时疼痛消失。Ⅱ、Ⅲ期临床免疫后,血清抗体阳转率14和45 d均为100%。试验组与对照组不良反应发生率和免疫后血清抗体阳转率差异均无统计学意义(P>0.05)。结论国产冻干人用狂犬病纯化疫苗(Vero细胞微载体)接种反应轻微,且具有良好的免疫原性。
Objective To observe the inoculation reaction and immunogenicity of domestic freeze-dried human rabies vaccine (Vero cell microcarrier). Methods A total of 10 to 60 years old healthy volunteers without history of canine disease, vaccination history of rabies vaccination and contraindications for vaccination were selected according to the inclusion criteria of clinical plans in Gaomi, Shandong Province. The patients were divided into stages Ⅰ, Ⅱ and Ⅲ Clinical trial, according to the immunization program, domestic rabies vaccination of domestic lyophilized human vaccine, phase Ⅱ clinical trials to import similar vaccine as a control, vaccination and immunogenicity observed. Results The incidence of adverse reactions in the experimental group after vaccination was low. The incidences of adverse reactions in groups Ⅰ, Ⅱ and Ⅲ were 6.1%, 7.8% and 7.7%, respectively. There were no moderate and strong reactions and the reactions were all at the injection site , Not accompanied by local swelling and induration, local weak reaction, no systemic reactions such as elevated body temperature, pain disappeared 72 h. After phase Ⅱ and Ⅲ clinical immunization, the positive rate of serum antibody was 100% at 14 and 45 days. No significant difference was found in the incidence of adverse reactions between the experimental group and the control group and the positive rate of serum antibody after immunization (P> 0.05). Conclusion The domestic rabies vaccine purified rabies vaccine (Vero cell microcarrier) inoculation reaction is mild, and has good immunogenicity.