Safety and immunogenicity of hepatitis A vaccine in healthy adult volunteers.

Abstract

The immunogenicity and adverse reaction of an inactivated hepatitis A (HA) vaccine were investigated. Sixty healthy adult volunteers who lacked antibody to HA virus (anti-HAV) received three doses of vaccine containing 720 enzyme-linked immunosorbent assay (ELISA) units (EL.U) according to a 0, 1 and 6 month schedule. Blood tests for serum liver enzymes and anti-HAV were performed at screening 7 days prior to, and 1, 6 and 7 months after the first dose. Anti-HAV was tested by radio immunoassay and ELISA for titre determination. The seroconversion rates measured by ELISA were 98.3% (59/60) at months 1 and 6 and 100% at month 7. Sixty-one per cent (109/180) of the documented injections were followed by local symptoms, essentially mild soreness at the site of injection; and 22.2% (40/180) by minor general symptoms including malaise, fatigue and lethargy. It is concluded that HA vaccine is highly immunogenic and safe. It may replace immunoglobulin as an effective method of preventing HA virus infection in adults.