Trivalent HBV Vaccine Superior in Efficacy in Adults 45 Years and Older

A Phase III study has found a trivalent hepatitis B virus (HBV) vaccine demonstrated superiority in adults 45 years and older and noninferior in adults older than 18 years compared with a monovalent vaccine. In the study, researchers compared the immunogenicity of a 10 gram dose of a trivalent vaccine (Sci-B-Vac, VBI Vaccines) with a 20 gram dose of monovalent vaccine (Engerix-B, GlaxoSmithKline) given at days 0, 28 and 168 in 1,607 individuals randomly assigned to one of the two vaccines and then tracked for safety outcomes to day 336. Participants were stratified by study center and age group: 18 years to 44 years and 45 years to 65 years and older. They found the seroprotection rate among recipients 18 years or older who received the trivalent vaccine was 91.4 percent compared with 76.5 percent for monovalent vaccine recipients. And, among individuals 45 years and older, the seroprotection rate was 89.4 percent with the trivalent vaccine versus 73.1 percent for the monovalent vaccine.

“When compared to Engerix-B, Sci-B-Vac tends to have higher rates of protection among adults over age 18 with superiority in those older than 45,” said Joanne M. Langley, MD, division head for infectious diseases and a professor of pediatrics and community health and epidemiology at Dalhousie University in Canada. “It also shows that all the subpopulations had higher seroprotection rates. Next steps are to write up the study and submit to regulators.” Another study underway will expand the safety data and provide additional seroprotection data in the 18- to 45-year-old age group.