New long-term follow-up clinical data for 3-antigen adult hepatitis B vaccine presented at EASL 2022.-VBI Vaccines Inc.
VBI Vaccines Inc. a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, announced that new data from a follow-up analysis of a subset of participants from the pivotal Phase III study (PROTECT) of the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, were presented in an oral presentation at The International Liver Congress 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on June 26, 2022.
Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase III clinical studies of VBI’s 3-antigen HBV vaccine, highlighted data from his investigator-initiated analysis that evaluated duration of immune response approximately 2.5 years after completion of vaccination. Immunogenicity was assessed using frozen sera samples from a subset of participants (n=465) who had been enrolled at five clinical sites in Finland as part of PROTECT. In the follow-up analysis, participants in PROTECT who received VBI’s 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI’s 3-antigen HBV vaccine retained anti-HBs titers greater than 100 mIU/mL compared to 32.6% of those who received Engerix-B.
“In the PROTECT study, more adults were protected with VBI’s 3-antigen vaccine than with the single-antigen vaccine, and in this follow-up analysis we continued to see the benefit of the 3-antigen vaccine,” said Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “As we focus on the road ahead and our commitment to broadening access to this vaccine in Europe and North America, we continue to believe that our 3-antigen vaccine has the potential to be a meaningful new intervention in the public health battle to eradicate hepatitis B.”
Detailed Results of the Follow-Up Study : i. Higher SPRs observed in participants who received VBI’s 3-antigen HBV vaccine (3A-HBV) vs. Engerix-B (1A-HBV) across all key subgroups after 2.5 years of follow up; Adults age 18+: 88.1% 3A-HBV vs. 72.4% 1A-HBV [difference: 15.7%].Adults 18-44 years: 96.2% 3A-HBV vs. 81.3% 1A-HBV [difference: 14.9%]. Adults 45-64 years: 90.3% 3A-HBV vs. 75.0% 1A-HBV [difference: 15.3%]. Adults greater than 65 years: 81.8% 3A-HBV vs. 65.2% 1A-HBV [difference: 16.6%].Individuals with obesity (BMI greater than 30): 86.3% 3A-HBV vs. 69.6% 1A-HBV [difference: 16.7%].
i. A higher percentage of participants who received 3A-HBV retained anti-HBs titers above 100 mIU/mL (72.9% vs. 32.6% - difference: 40.3%).
ii. increase in anti-HBs titers observed in participants who received 3A-HBV vs. 1A-HBV.
In the PROTECT study, peak antibody titers (Day 196) were 2.1x higher in participants who received 3A-HBV vs. those who received 1A-HBV [8021.9 mIU/mL vs. 3787.3 mIU/mL] In the 2.5-year follow-up study, mean peak antibody titers were 5.5x higher in participants who received 3A-HBV vs. those who received 1A-HBV [1382.9 mIU/mL vs. 251.4 mIU/mL].
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