HBV-16 Trial
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Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years
HBV-16 Trial: Study Design
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Phase 3 randomized observer-blinded controlled trial to compare the safety and efficacy of
Heplisav-B versus Engerix B vaccines in healthy adults 40-70 years of age
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Ages: 40-70 years
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HBV vaccine naïve
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Exclusions: HBV*, HIV, pregnancy or lactation, autoimmune or other clinically significant
illness, immunosuppressed
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Seroprotection = anti-HBs level ≥10 mIU/mL
Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
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Any positive test for HBsAg, anti-HBs, or anti-HB core
Bridging vaccine lot: for safety analysis only
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years
HBV-16 Trial: Design
Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
n = 1,441
n = 483
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Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years
HBV-16 Trial: Results
Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
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Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years
HBV-16 Trial: Results
Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
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Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years
HBV-16 Trial: Adverse Reactions
Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years
HBV-16 Trial: Conclusions
Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
This slide deck is from the University of Washington’s
Hepatitis B Online
and
Hepatitis C Online
projects.
Hepatitis B Online
www.hepatitisB.uw.edu
Hepatitis C Online
www.hepatitisC.uw.edu
This project is funded by the Centers for Disease Control and Prevention (CDC)
Cooperative Agreement (CDC-RFA- PS21-2105)
Heplisav-B vs. Engerix-B comparison study in healthy adults aged 40-70 years, evaluating safety, efficacy, and adverse reactions of the vaccines. Phase 3 trial with 2,520 participants, examining seroprotection levels and vaccine dosing. Results show both vaccines achieved anti-HBs levels above 10 mIU/mL, with some differences in adverse reactions observed. The study provides valuable insights for HBV vaccination in this age group.
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Heplisav-B vs Engerix-B in Healthy Adults, Aged 40-70 Years HBV-16 Trial
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years HBV-16 Trial: Study Design Design - Phase 3 randomized observer-blinded controlled trial to compare the safety and efficacy of Heplisav-B versus Engerix B vaccines in healthy adults 40-70 years of age Participants n = 2,4520 - Ages: 40-70 years - HBV vaccine na ve - Exclusions: HBV*, HIV, pregnancy or lactation, autoimmune or other clinically significant illness, immunosuppressed Setting - Multiple centers in United States & Canada Study End-Point - Seroprotection = anti-HBs level 10 mIU/mL *Any positive test for HBsAg, anti-HBs, or anti-HB core Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years HBV-16 Trial: Design 24 28 32 0 4 8 12 20 16 Week Heplisav-B 1 2 P Placebo n = 1,441 Heplisav-B 1 2 P Placebo n = 528 Bridging vaccine lot: for safety analysis only Engerix-B 1 2 3 n = 483 Vaccine Dosing Heplisav-B: 0.5 mL dose of 3 mg 1018 adjuvant with 20 mcg recombinant HBsAg at week 0 and 4 Engerix-B: 1 mL dose of 20 mcg recombinant HBsAg with aluminum adjuvant at week 0, 4 and 24 Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years HBV-16 Trial: Results Heplisav-B Engerix-B Primary Endpoint 100 95.1 94.8 94.8 94.3 93.4 91.9 90.0 Anti-HBs 10 mIU/mL (%) 80 76.6 72.8 70.5 60 65.6 59.8 59.0 40 19.6 20 21.4 20.3 17.0 4.5 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Week Heplisav-B 1 2 3 Engerix-B 1 2 Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years HBV-16 Trial: Results Primary Endpoint Heplisav-B Engerix-B 100 90.0 Anti-HBs 10 mIU/mL (%) 80 70.5 60 40 20 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Week Heplisav-B 1 2 3 Engerix-B 1 2 Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years HBV-16 Trial: Adverse Reactions Heplisav-B (n = 1,968) Engerix-B (n = 481) Adverse Event, no. (%) Local reaction (among n=1953) Total 666 (34) 154 (32) Severe 11 (0.6) 3 (0.6) Systemic reaction (among n=1953) Total 586 (30) 166 (35) Severe 42 (2) 19 (4) Any related adverse event (AE) 142 (7) 29 (6) Any related severe AE (grade 3 or above) 0 1 (0.2) Any AE leading to study discontinuation 17 (0.9) 2 (0.4) Death 1 (0.05) 1 (0.2) Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 40-70 Years HBV-16 Trial: Conclusions Conclusions: When compared to the HBsAg-Eng three-dose regimen given at 0, 1, and 6 months, HBsAg-1018 demonstrated superior seroprotection with only two doses at 0 and 1month. The safety profile of HBsAg-1018 was comparable to that of the licensed vaccine, HBsAg-Eng. HBsAg-1018 would provide a significant public health contribution toward the prevention of hepatitis B infection. Source: Heyward WL, et al. Vaccine. 2013;31:5300-5.
This slide deck is from the University of Washingtons Hepatitis B Online and Hepatitis C Online projects. Hepatitis B Online www.hepatitisB.uw.edu Hepatitis C Online www.hepatitisC.uw.edu This project is funded by the Centers for Disease Control and Prevention (CDC) Cooperative Agreement (CDC-RFA- PS21-2105)
