摘要
根据卫生部药审(91)特申体第02号文件,本品纯化灭活双价疫苗92年完成了Ⅰ期人体反应及血清学效果观察。91001批双价疫苗以0,1,2月和0,14,35天程序免疫,91002批以0,1,2月程序免疫,各接种15人。接种后未出现任何不良反应,与Ⅰ型,Ⅱ型单价疫苗相同,是安全可靠的。两种免疫程序,二针次免疫后皆能产生较高免疫抗体,接种后半年仍保持一定抗体水平。中和抗体(PRNT)均在1∶10～1∶20,ELISA1∶478～1∶549(GMT),阳转率100％,再次证明本型纯化疫苗安全有效,并具有较高免疫活性,本型疫苗也可采用二针次(0,1月),总量2ml免疫。
The phase I clinical trial of divalent durified EHF vaccine by the national control autority in 1991.
91001,91002 final lots of divalent purified EHF vaccine was Predared with sukling mouse brain using type Ⅰ LR1 and type Ⅱ R22SM strain. The envelop glycoprotein G1,G2 and nucleoc-apsid protein N of Hantaan virus have been only cantained in the divalent purified FHF vaccine ( i.e.purified subunits vaccine). It was inactivation by 1:6000 β-prodiolactone. The results on examination showed that no live virus was detected in vaccine after 3 passages in vero-E6 cells. Antigen titers werel :1024~1:2048 by ELISA, 1 :256~1 :5 12 by RPHA, 1 :32~1 :64 by C.F; Neutralizing antibodies Produced in rabbits were≥1 :20 by PRNT and serum titers were 1 :2048~1 :4096 by ELISA, 1 :256~1 :512 by RPHI to EHF LR1 and R22SM stains after two injections with the divalent vaccine. The final lot of vaccine ( 91001,91002 ) had been stored at 2 ~ 8 ℃ for 17 months.
In order to invectigate the immune reaction of divalent EHF vaccine,30 volunteers were immunized sparately t The 0 , 1, 2 month and0,14,35 days with 91001 lot of divalent vaccine. Another 15 volunteers,at 0 , 1 , 2 months with 91002. There was no side effects or local and general reaction aften each inoculations. It is the same as sefe as single vaccine ( type Ⅰ and Ⅱ ) . Highter immune antibody was able to production after two inoculations of volunteers. Seroconversion rate was 100%, neutralizing antibodies reached 1:10~1:20 by PRNT, immune antibodies wese ELISA 1 :478~549 ( GMT ),RPHI 1 :128~158 ( GMT ) .After tree injection(3 doses) immune antibody titers of vaccine were better than that of two inocuations,but the tilers of immunized antibody among 3 group are no statistical difference and it could still be remained at same level after half year.
The result showed that the antibody tilers of divalent EHF vaccine is highter than that of type Ⅰ and Ⅱ ( monovalent ) EHF vaccine. It is assumed that this may be due to the comfination and since an ingredients of cross reacting antigen of type Ⅰ and Ⅱ EHF virus in the divalent vaccine were increased and thus enhaned the immunogenicity of the vaccine.
The data obtained suggest that divalent EHF vaccine contains highter antimicrobial activity,and is endowed with the ability to resist the infection of EHF virus. It were safe and effective for human and could be adopted 2 vaccinations with a total of 2ml. It can be used widely in urban and rural and mixed EHF areas to proventive inoculation against EHF.
出处
《微生物学免疫学进展》
1993年第4期1-4,共4页
Progress In Microbiology and Immunology
基金
国家"八五"攻关课题
国家科委火炬计划项目
关键词
流行性出血热
疫苗
临床
Epidemic Haemorrhagic fever ( EHF ) ivalent EHF purified vaccine clinical trial
