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Two-dose combined vaccination against hepatitis A and B in healthy subjects aged 11-18 years
K Van Herck1, P Van Damme, F Collard
1Centre for the Evaluation of Vaccination, WHO Collaborating Centre for Prevention and Control of Viral Hepatitis, Epidemiology and Community Medicine, University of Antwerp, Belgium.
Background:
In this open, randomized trial the safety, reactogenicity, and immunogenicity profile of a high-dose combined hepatitis A and B candidate vaccine was compared with that of Twinrix Paediatric in healthy volunteers aged 11-18 years.
Methods:
One hundred subjects were randomly allocated to either of two groups. One group received the high-dose vaccine (720 E1.U HAV antigen; 20 microg hepatitis B surface antigen (HBsAg) at months 0 and 6; the second group received Twinrix Paediatric (360 E1.U HAV antigen; 10 microg HBsAg), following a 0-1-6-month schedule.
Results:
Injection site soreness and fatigue were the most frequently reported solicited symptoms. For hepatitis A all subjects had seroconverted at month 7, and geometric mean titres (GMT) were 8,151 mIU/ml in the high-dose group and 6,394 mIU/ml in the Twinrix Paediatric group. For hepatitis B the GMT for the Twinrix Paediatric group was significantly higher at month 2 and month 6. However, no difference in GMT between groups could be established at month 7. The seroprotection rate attained 100% in both groups, and GMT were 4,212 mIU/ml (high-dose group) and 6,330 mIU/ml (Twinrix Paediatric).
Conclusions:
The two vaccines showed similar safety and reactogenicity profiles. After completion of the vaccination schedule, no difference in immunogenicity was shown. This high-dose vaccine, administered following a two-dose schedule, can be considered an alternative regimen for the immunization of healthy adolescents against hepatitis A and hepatitis B infections, in a setting where vaccinees are not immediately at risk of exposure to hepatitis B.