This was a randomized controlled, double-blind study assessing the rea
ctogenicity and immunogenicity of newly produced vs 2 year old hepatit
is A vaccine. Overall 215 non-immune volunteers, 18-39 years old were
divided into four groups and administered vaccine at months 0, 1 and 6
. Three groups each received a different vaccine lot which had been st
ored at 4 degrees C for 2 years, and one group received recently produ
ced vaccine as control. The mean local and general adverse reaction ra
tes were 59.1% and 17.4%, respectively, and all vaccinees had seroconv
erted by month 2. There were no significant differences in geometric m
ean anti-hepatitis A virus (HAV) antibody titres between the four grou
ps. In conclusion 2 year old HAV vaccine is safe and equally immunogen
ic as newly produced vaccine. Copyright (C) 1996 Elsevier Science Ltd.