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

Liver International May 12, 2021

Koc OM, De Smedt P, Kremer C, et al. - This study was undertaken to investigate the immunogenicity and safety of a new HBAI20 vaccine, consisting of a new AI20 adjuvant (20µg recombinant human IL‐2 attached to 20µg aluminum hydroxide) in combination with HBVaxPro®‐10µg. Researchers designed a double‐blind, randomized, controlled phase 2 trial assigning 18–59 years old healthy non‐responders (titre < 10 mIU/mL after three or more doses of hepatitis B vaccine) in a 3:1 ratio to receive either HBAI20 vaccine or HBVaxPro®‐10µg in a 0, 1 and 2 months schedule. A total of 133 individuals were assigned randomly to receive either the HBAI20 vaccine (n=101) or HBVaxPro®‐10µg (n=32). The data exhibited that the HBAI20 vaccine demonstrated a higher seroprotection rate in this group of hepatitis B vaccine non‐responders when adjusting for stratification factors and a similar safety profile compared to the licensed recombinant HBVaxPro®‐10µg.

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