Accession Number:

ADA209684

Title:

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

Descriptive Note:

Final rept. 1 May 1986-30 Apr 1989

Corporate Author:

FLOW LABS INC MCLEAN VA

Personal Author(s):

Report Date:

1989-06-01

Pagination or Media Count:

9.0

Abstract:

Tests of seed and vaccine materials for safety in humans consisted fo 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 andor 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

Subject Categories:

  • Microbiology
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE