人群接种双价肾综合征出血热纯化疫苗后的安全性和血清学临床研究

Study on the Safety and Serologic Effect of the Crowd Inoculated Bivalent Inactived Purified Vaccine (Vero cell) Against HFRS

目的评价双价肾综合征出血热(HFRS)纯化疫苗(Vero细胞)在人群中接种的安全性和免疫性,为确定2针基础免疫程序及进行市场推广的可行性论证提供依据。方法对每位接种者进行临床观察和血清学检测,用间接免疫荧光法(IFAT)检测特异性IgG抗体,用空斑减少中和试验(PRNT)检测中和抗体。结果全身及局部总反应率分别为3.66%和1.83%,均为轻度反应,且基本于接种后3d内消退。2针基础免疫前后双份血清81份,用IFAT和PRNT检测免前抗体均为阴性,免后抗体阳转率分别为95.06%、Ⅰ型90.12%、Ⅱ型91.35%。结论该疫苗的安全性和免疫原性均较好。

Objective In order to estimate the safety and immunological efficacy of new vaccine “bivalent purified vaccine against HFRS (Vero cell)” which was supplied by Bailong Biological Technology Limited Company,Changchun.To provide clue for ensuring Two injection primary immunization procedure and the feasibility of extending. Methods All the inoculated objective were observed by follow up system and local response after each injection, sera were collected before and after inoculation, immunofluorescent antibody assay was used to detect specific IgG antibody, and Mcro CPE method was used to detect the titer of the neutralizing antibody. Results The rates of slight temperature rise and slight local response were 3.66% and 1.83% , respectively, of which side effects were slight and had been faded out in three days. We collected 81 pieces of double serum about before primary immunization and after all the immunization.The IFAT and MCPENT antibody reactions were negative before primary immunization, while twenty one days after the second injection,the rate of seroconversion of the immunofluorescent antibody by IFAT was 95.06% . The rates of seroconversion of type Ⅰ and typeⅡ neutralization antibody were 90.12% and 91.35% , respectively.Conclusion It shows the vaccine was safe and the immunological efficacy was satisfied.