Safety Testing of Dengue-1 and Dengue-3 Seeds for Human Challenges, Unattenuated; Hepatitis A Virus, Strain HM-175

摘要

Tests of seed and vaccine materials for safety in humans consisted of inoculation in: 1) five different cell culture lines; 2) mice (adult and new-born sucklings), guinea pigs and rabbits; and 3) bacterial, fungal and mycoplasma culture media. The inocula for these tests included crude, unclarified harvests of both control and virus fluids (neutralized and/or un-neutralized). Tested were the following fluids: unattenuated dengue-1, dengue-3 and dengue-4 virus seed lots, a Japanese encephalitis (JE) production seed and vaccine, a hepatitis A vaccine. Tests of the Final Products included: 1) sterility; 2) inocuity in mice and guinea pigs; and 3) reverse transcriptase activity. Final Products of a JE and a hepatitis A vaccine were tested. In an effort to attenuate a dengue-1 vaccine lot, the virus was subjected to 10 serial passages in dog kidney cell cultures. (aw)