Primary study of attenuated live hepatitis A vaccine (H2 strain) in humans.

Strain H2, an attenuated live hepatitis A virus (HAV), was derived from the fecal specimen of a patient with hepatitis A in Hangzhou, China. After isolation and passage in a culture of newborn monkey kidney cells, adaptation to grow in human lung diploid cells (KMB17), and serial passage at a low temperature (32 degrees C) in KMB17 cells, this strain became the master seed virus for H2-strain vaccine. Twelve human volunteers received the experimental vaccine subcutaneously and were closely observed for 20 w. None of the subjects developed any local or systemic reactions, and there were no elevations of serum glutamic-pyruvic transaminase, type 5 isoenzyme of lactate dehydrogenase, or isocitrate dehydrogenase. Seroconversion occurred in all subjects at a mean time of 3 w after inoculation. ELISA competitive test for titer of antibody to HAV showed values ranging from 1:2 to 1:8 with a geometric mean titer of 1:3.48 at 20 w after inoculation. No marked decrease in titer of HAV antibody was found in the subjects tested at 1 y. These antibodies were proved to be neutralizing antibodies.