Armstrong M E, Giesa P A, Davide J P, Redner F, Waterbury J A, Rhoad A E, Keys R D, Provost P J, Lewis J A
Department of Virus and Cell Biology, Merck Research Laboratories, West Point, PA 19486.
J Hepatol. 1993;18 Suppl 2:S20-6. doi: 10.1016/s0168-8278(05)80373-3.
The development of the formalin-inactivated hepatitis A vaccine, VAQTA, culminates nearly two decades of the basic science studies of VAQTA in hepatitis A virology at the MRL. The master seed virus for production of VAQTA 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 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.
福尔马林灭活甲型肝炎疫苗VAQTA的研发，是美国陆军医学研究实验室（MRL）近二十年来对甲型肝炎病毒学进行基础科学研究的成果。用于生产VAQTA的主种子病毒源自CR326F株的F'(P18)变异体，该变异体已在人体临床试验中进行研究，并显示出高度减毒。抗原经过高度纯化，以便通过福尔马林进行一致且彻底的灭活。VAQTA的I期临床研究于1989年启动，此后不断推进，直至最近的III期临床试验，该试验证明单剂量疫苗在纽约州门罗的儿科人群中预防临床甲型肝炎疾病具有疗效。
