Comparison of the reactogenicity and immunogenicity of two different dose levels of hepatitis A vaccine in healthy children and adolescents.

An open study was performed to compare the reactogenicity and immunogenicity of an inactivated hepatitis A vaccine administered in two different doses and schedules to 460 healthy volunteers aged 3-18 years. Participants were randomized to two groups to receive either two doses of 720 ELISA Units (EL.U) inactivated hepatitis A per 0.5 ml dose according to a 0, 6-month schedule, or three doses of 360 EL.U according to a 0, 1, 6-month schedule. Transient local injection soreness was the most commonly reported symptom in almost half of both groups with no serious adverse events. One month after the primary course (one dose of 720 EL.U and two doses of 360 EL.U), 99% of 720 EL.U vaccinees had seroconverted, compared with 100% seroconversion in the 360 EL.U group. All vaccinees were seropositive after the booster dose of both vaccines with geometric mean anti-HAV titers of 2,359 and 2,967 mIU/ml in the 720 EL.U and 360 EL.U groups, respectively. The vaccine containing 720 EL.U of antigen per dose offers the advantage of convenience and acceptance of immunization afforded by a two-dose course of vaccination accompanied by a comparable antibody response with that achieved after three doses of vaccine containing 360 EL.U of antigen per dose.