Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial
RCT (n=1607) met both its co-primary endpoints. Tri-antigenic vaccine (TAV) was non-inferior to mono-antigenic vaccine (MAV) and induced higher seroprotection rate vs MAV after 3 doses, with statistical and clinical superiority in adults aged 45 years or older.
Source:
The Lancet Infectious Diseases
SPS commentary:
This trial is the first to investigate the non-inferiority and superiority of TAV compared with a standard dose of MAV in a primarily older adult population. The authors suggest that a more potent hepatitis B vaccine that is more immunogenic, induces seroprotection faster, eliminates the need for re-vaccinations, and has a favourable safety profile has important public health implications.
According to a commentary, in contrast to the current monovalent hepatitis B vaccines that contain only the small hepatitis B virus (HBV) surface antigen, the third generation Sci-B-Vac vaccine contains all three HBV envelope proteins, the small (HBsAg), medium (preS2), and large surface (preS1) antigens. Therefore, this vaccine can better enhance immunity by the expression of highly immunogenic T and B cell epitopes. It notes that the study results comprise the basis for the regulatory submissions of the tri-antigenic hepatitis B vaccine in the USA, Europe, and Canada. Results show there may be potential for the use of TAV in susceptible populations which might represent a step forward towards the global eradication of hepatitis B.