Adult hepatitis B vaccination using a novel triple antigen recombinant vaccine

Present hepatitis B vaccines use multidose prolonged regimens, which even h ealthcare workers at risk do not always complete. Moreover, when vaccinatio n is completed there remain some who fail to achieve adequate protection. T he protection of adults at risk could be improved if there were a more pote nt vaccine and/or a shorter vaccination regimen available. Vaccine-naive ad ults were randomized to vaccination with either Engerix-B (SmithKline Biolo gicals, Rixensart, Belgium) or a novel triple antigen (S, pre-S1, and preS2 ) recombinant vaccine (Hepacare; Medeva Pharma Plc, Speke, UK). The primary efficacy parameter was the degree of seroprotection 6 or 7 months (26 +/- 2 weeks) after beginning vaccination, A total of 304 adults entered the stu dy. Of these, 16 failed to complete the study (9 on Hepacare and 7 on Enger ix-B). With the Engerix-B standard (0, 1, 6) regimen, 88% of subjects were protected by month 7, whereas with the triple antigen vaccine a 2-dose regi men (0, 1) provided equivalent protection (91%) within 6 months and a 3-dos e (0, 1, 6) regimen was significantly superior (98% seroprotected by 7 mont hs after starting vaccination P < mi). with adults at risk for a suboptimal response (i.e., older adults, the obese, men, and smokers) the triple anti gen vaccine produced a greater degree of protection. The vaccines had simil ar safety profiles. Both vaccines were well tolerated. In healthy normal ad ults, a triple antigen hepatitis B vaccine containing S and pre-S antigens produced an enhanced immunologic response and was as effective as a 2- and 3-dose regimen.