Immunogenicity and safety of a tri-antigenic versus a mono-antigenic hepatitis B vaccine in adults (PROTECT): a randomised, double-blind, phase 3 trial

Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine

“…The higher reactogenicity of 3A-HBV noted in this study, which was mostly of mild or moderate severity and short duration, is consistent with the safety profile known from previous clinical trials of 3A-HBV 15,18,19,27 and postmarketing experience. Completion of the 3-dose schedule for 3A-HBV was high (93.0%), and study discontinuation due to SAEs or AEs was rare (0.4%).…”

“…T-helper epitopes in the pre-S1/S2 domains overcome genetic nonresponsiveness to induce antibodies to S. 22,23 Also, 3A-HBV is produced in mammalian CHO cells, which are used extensively in safe human biologics production 24 ; and unlike yeast-derived 1A-HBV, 3A-HBV has a mammalian protein folding and glycosylation pattern that enhances vaccine immunogenicity. 25 The SPRs reported for 3A-HBV following a 3-dose regimen in this study (99.3%) are slightly higher than those reported in PROTECT (91.4%), 15 which enrolled individuals aged 18 to 90 years in stable health, including those with well-controlled chronic conditions. Of note, the SPR in age subgroup of those aged 18 to 44 years in PROTECT (99.2%) 15 was almost identical to overall SPR of the pooled 3A-HBV in this study's participants, who were aged 18 to 45 years (99.4%).…”

“…The 3A-HBV vaccine is a recombinant, 3-antigen vaccine that has shown, in clinical trials, to induce high antibody concentrations resulting in high SPRs 15,18,19,28 against HBV, which can cause a lifelong chronic infection with a high risk of liver fibrosis, cirrhosis, and hepatocellular carcinoma if left untreated. The 3A-HBV vaccine has been shown to achieve high SPRs and induce anti-HBs concentrations across diverse healthy adult populations in Asia, Europe, and North America 15,17,19 and also in key subgroups of older adults with poor or delayed responses to standard-of-care HBV vaccines. 15 JAMA Network Open | Infectious Diseases Limitations…”

“…The 3A-HBV vaccine has been shown to achieve high SPRs and induce anti-HBs concentrations across diverse healthy adult populations in Asia, Europe, and North America 15,17,19 and also in key subgroups of older adults with poor or delayed responses to standard-of-care HBV vaccines. 15 JAMA Network Open | Infectious Diseases Limitations…”

Hepatitis B virus middle surface antigen loss promotes clinical variant persistence in mouse models

“…Taken together, the importance of MHBs for hepatitis B vaccine development has been emphasized in clinical trial [ 42 ]. Although disease activity and monitoring of treatment response in CHB patients can be predicted through the quantification of HBsAg [ 25 , 43 , 44 ], the biological function of MHBs remains largely unknown.…”