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We assessed the immunogenicity of the paediatric dose of Epaxal(®) (0.25 mL) and the degrees of seroprotection achieved with the standard dose (0.5 mL) of Epaxal(®) or a dose of Havrix(®) Junior, in children in an open, randomised, controlled, multi-centre, parallel-group study conducted at 2 Chilean study centres. 360 healthy children and adolescents 12 months to

Immunogenicity and tolerability of a new formalin-inactivated, alum-adjuvanted whole virus vaccine against hepatitis A (VAQTA, MSD, West Point, USA) were evaluated by immunizing 52 healthy, anti-HAV negative volunteers with a 1 ml dose. A booster dose was given 6 months later. In these young adult vaccinees [27 males and 25 females, 19–34 (mean 26) years of age] VAQTA proved to be well tolerated and highly immunogenic. Two weeks after administration of one vaccine dose, all but one of the recipients (98%) had anti-HAV concentrations above the presumed minimum protective level of 10 IU l −1 with a geometric mean concentration (GMC) of 165 IU l −1 . After 4 weeks, a 100% seroconversion rate could be demonstrated with a fourfold increase of the GMC to 728 IU l −1 . Six months after vaccination, all but one of the 50 volunteers coming back for booster (98%) showed anti-HAV levels within the protective range. The antibody concentrations had decreased in the majority of vaccinees to a GMC of 362 IU l −1 . The booster dose given at that time was shown to be very effective, leading to a pronounced rise of anti-HAV levels in all recipients with a 17-fold increase of the GMC to 6040 IU l −1 . Six months after the booster, all vaccinees were still seropositive with a GMC of 3444 IU l −1 . Higher antibody levels were found in females, the difference being significant 4 weeks and 6 months after vaccination and 4 weeks after booster. No serious local or systemic adverse reactions were observed.

A placebo-controlled, double-blind study on the efficacy of a hepatitis A vaccine (SmithKline Beecham Biologicals) was started in a region of Chile in September 1990, using hepatitis B vaccine as control. A total of 260 healthy children, 6–15 years of age, negative for antibody to hepatitis A virus (anti-HAV), antibody to HAV immunoglobulin M (IgM), hepatitis B surface antigen, and antibody to hepatitis B surface and core antigens by ELISA tests within 7 days before vaccination, were randomly assigned to two study groups: 128 children received the vaccine with a yellow label (group 1), and 132 children the vaccine with an orange label (group 2) at months 0, 1 and 6. Blood for serology and transaminase determination was drawn at months 1, 2, 6, 7 and 12. Both vaccines were tolerated equally well and no serious side effects were seen. In group 1 (presumed hepatitis A vaccine group), anti-HAV was detected (20% inhibition was used as the cut-off level) in 122 of 128 children (95.5%) tested at month 1, in 126 of 127 (99.2%) at month 2, in 126 of 127 (99.2%) at month 6 and in 126 of 126 (100%) at month 7. One anti-HAV seroconversion seen at month 1 was associated with presence of anti-HAV IgM and therefore probably represents HAV infection. Geometric mean anti-HAV concentration of the other children was 128, 342, 214 and 2301 mIU/ml at months 1, 2, 6 and 7, respectively. In group 2 (presumed hepatitis B vaccine group), three anti-HAV seroconversions, all associated with transient appearance of anti-HAV IgM, were detected at months 1 and 2. The difference in HAV infection rate seen in the two vaccine groups is not significant at month 12 of the study.