Literature DB >> 8182268

Development of the formalin-inactivated hepatitis A vaccine, VAQTA from the live attenuated virus strain CR326F.

M E Armstrong1, P A Giesa, J P Davide, F Redner, J A Waterbury, A E Rhoad, R D Keys, P J Provost, J A Lewis.   

Abstract

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.

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Year:  1993        PMID: 8182268     DOI: 10.1016/s0168-8278(05)80373-3

Source DB:  PubMed          Journal:  J Hepatol        ISSN: 0168-8278            Impact factor:   25.083


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