论文部分内容阅读
目的观察国产无佐剂Vero细胞狂犬病疫苗全程接种后的不良反应和免疫持久性,为完善再次暴露后疫苗的免疫程序提供依据。方法将医院犬伤门诊暴露后前来进行狂犬病疫苗接种者分为A、B两组:A组为Ⅱ级咬伤者,全程仅接种国产无佐剂Vero细胞狂犬病疫苗;B组为Ⅲ级咬伤者,接种国产无佐剂Vero细胞狂犬病疫苗加人狂犬病免疫球蛋白。电话调查并记录观察对象接种每剂无佐剂Vero细胞狂犬病疫苗及人狂犬病免疫球蛋白后7 d内的不良反应以及随访期间严重不良反应情况;接种前、接种后6周、6月、1年、2年、3年分别采集血清,采用快速荧光灶抑制试验(rapid fluorescent focus inhibition test,RFFIT)检测狂犬病病毒中和抗体,分析中和抗体≥0.5 IU/ml的有效保护水平以及抗体几何平均滴度(GMT)。结果疫苗接种后7 d内和随访期间未发生严重不良反应。疫苗接种后6周、6月、1年、2年、3年有效保护中和抗体(≥0.5 IU/ml)阳性率分别为97.5%、100%、73.9%、21.1%、20%;中和抗体GMT分别为4.584 6、2.226 9、1.146 6、0.506 3、0.408 5,中和抗体水平随着时间的延长呈显著下降趋势(P<0.01);加强免疫后中和抗体水平显著升高,并持续较长时间。结论国产无佐剂Vero细胞狂犬病疫苗的安全性和耐受性良好,接种后2年抗体水平降至与接种后3年相近的低水平,建议2年后再次暴露者全程接种5剂狂犬病疫苗。
OBJECTIVE To observe the adverse reactions and immune persistence of domestic rabies vaccine without vaccine adjuvant after vaccination in order to improve the immunization program of vaccine after re-exposure. Methods The rabies vaccination patients were divided into A and B groups after the outpatient inpatients were exposed to rabies. The patients in group A were grade Ⅱ bitten rabbits and were only vaccinated domestic rabies vaccine without Vero cells. The rabbits in group B were grade Ⅲ bite Wounded, vaccinated domestic non-adjuvanted Vero cell rabies vaccine plus rabies immunoglobulin. The phone surveyed and recorded the adverse reactions within 7 days after inoculation of each dose of non-adjuvanted Vero cell rabies vaccine and human rabies immunoglobulin and the serious adverse reactions during the follow-up; before vaccination, 6 weeks, 6 months and 1 year after inoculation Serum samples were collected at 2 years and 3 years respectively. Rabies virus neutralizing antibodies were detected by rapid fluorescent focus inhibition test (RFFIT). The effective protection level of neutralizing antibody≥0.5 IU / ml and the geometric mean drop of antibody Degree (GMT). Results No serious adverse reactions occurred within 7 days after vaccination and during follow-up. The positive rates of effective protective neutralizing antibodies (≥0.5 IU / ml) at 6 weeks, 6 months, 1 year, 2 years and 3 years after vaccination were 97.5%, 100%, 73.9%, 21.1% and 20% The antibody GMT was 4.584 6,2.226 9,1.146 6,0.506 3,0.408 5, the level of neutralizing antibody decreased significantly with time (P <0.01), and the level of neutralizing antibody was significantly increased after boosting Continues for a long time. Conclusion The domestic vaccine-free Vero cell rabies vaccine is safe and well-tolerated. The antibody level dropped to a low level at 3 years after inoculation 2 years after inoculation. It is recommended that 5 rabies vaccines be vaccinated again after 2 years of re-exposure.