Immunogenicity and safety of HBAI20 Hepatitis B vaccine in non-responders: Double-blinded, randomised, controlled phase 2 trial

Background & Aims Approximately 5%-10% of the general population respond inadequately to licensed recombinant hepatitis B vaccines. We assessed the immunogenicity and safety of a new HBAI20 vaccine, consisting of a new AI20 adjuvant (20-mu g recombinant human IL-2 attached to 20-mu g aluminium hydroxide) in combination with HBVaxPro (R)-10 mu g.Methods In a double-blinded, randomised, controlled phase 2 trial, 18- to 59-year-old healthy non-responders (titre <10 mIU/ml after three or more doses of hepatitis B vaccine) were assigned (3:1 ratio) to receive either HBAI20 vaccine or HBVaxPro (R)-10 mu g in a 0, 1 and 2-month schedule. The primary outcome was seroprotection (titre >= 10 mIU/ml) measured 1-3 months following the third vaccination.Results A total of 133 participants were randomised to receive either HBAI20 vaccine (n = 101) or HBVaxPro (R)-10 mu g (n = 32). In the modified intention-to-treat analysis, the seroprotection rate after the third vaccination was 92.0% (80/87) in the HBAI20 group and 79.3% (23/29) in the HBVaxPro (R)-10-mu g group, P = .068. Using a generalised linear mixed model to adjust for stratification factors, a higher odds of seroprotection with HBAI20 vaccine was shown (adjusted odds ratio = 3.48, P = .028). Frequency of mild and moderate local adverse events was greater in the HBAI20 group than in the HBVaxPro (R)-10 mu g. Rates of severe local adverse events and systemic adverse events were low and similar in both groups.Conclusions In this group of hepatitis B vaccine non-responders, the HBAI20 vaccine demonstrated a higher seroprotection rate when adjusting for stratification factors and a similar safety profile compared to the licensed recombinant HBVaxPro (R)-10 mu g.