DEVELOPMENT OF THE FORMALIN-INACTIVATED HEPATITIS-A VACCINE, VAQTA(TM) FROM THE LIVE ATTENUATED VIRUS-STRAIN CR326F

被引:38
作者
ARMSTRONG, ME [1 ]
GIESA, PA [1 ]
DAVIDE, JP [1 ]
REDNER, F [1 ]
WATERBURY, JA [1 ]
RHOAD, AE [1 ]
KEYS, RD [1 ]
PROVOST, PJ [1 ]
LEWIS, JA [1 ]
机构
[1] MERCK SHARP & DOHME LTD,MERCK RES LABS,DEPT VIRUS & CELL BIOL,W POINT,PA 19486
关键词
ATTENUATED VIRUS; FORMALIN INACTIVATION; HAV CR326F; VACCINE PURIFICATION; 80S AND 150S PARTICLES;
D O I
10.1016/S0168-8278(05)80373-3
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
The development of the formalin-inactivated hepatitis A vaccine, VAQTA(TM), culminates nearly two decades of the basic science studies of VAQTA(TM) in hepatitis A virology at the MRL. The master seed virus for production of VAQTA(TM) is derived from the F'(P18) variant of the strain CR326F which has been studied in human clinical trials and shown to the highly attenuated. The antigen is highly purified to make possible the consistency and thoroughness of its inactivation by formalin. Phase I clinical studies of VAQTA(TM) were initiated in 1989 and have progressed since that time to the recent Phase III clinical trials which demonstrated efficacy of a single dose of the vaccine in preventing clinical hepatitis A disease in pediatric populations in Monroe, NY.
引用
收藏
页码:S20 / S26
页数:7
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