Heplisav-B Versus Engerix-B in Healthy Adults Aged 18-55 Years

The Heplisav-B versus Engerix-B study compared the safety and efficacy of these vaccines in healthy adults aged 18-55 years. Heplisav-B showed higher seroprotection rates for anti-HBs compared to Engerix-B. Baseline characteristics and vaccine dosing details were also analyzed. Results indicated superior performance of Heplisav-B in achieving the primary endpoint.

• Heplisav-B
• Engerix-B
• Vaccine Study
• Healthy Adults
• Seroprotection

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1. Heplisav-B versus Engerix-B in Healthy Adults, Aged 18-55 Years HBV-10 Trial

2. Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 18-55 Years HBV-10 Trial: Design Design - Phase 3 observer-blinded randomized controlled trial to compare the safety and efficacy of Heplisav-B versus Engerix-B in healthy adults Participants - Ages 15-55 years^ - HBV vaccine na ve - Exclusions: HBV*, HIV, pregnancy (or lactation), autoimmune or other clinically significant illness, immunosuppressed Setting - Multiple centers in Canada and Germany Study End-Point - Seroprotection = anti-HBs level 10 mIU/mL ^Adolescents age 11-17 years were eligible, but most had previously received HBV vaccine as child as part of universal vaccine program. *Any positive for HBsAg, anti-HBs, or anti-HB core Source: Halperin SA, et al. Vaccine. 2012;30:2256-63.

3. Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 18-55 Years HBV-10 Trial: Design 24 28 0 4 8 12 20 16 Week Heplisav-B 1 2 P 3x Placebo n = 1,809 Randomized 1x Engerix-B 1 2 3 n = 606 Vaccine Dosing Heplisav-B: 0.5 mL dose of 3 mg CpG 1018 adjuvant with 20 mcg recombinant HBsAg at week 0 and 4, followed by administration of saline placebo at week 24 Engerix-B: 1 mL dose of 20 mcg recombinant HBsAg at week 0, 4 and 24 Source: Halperin SA, et al. Vaccine. 2012;30:2256-63.

4. Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 18-55 Years HBV-10 Trial: Baseline Characteristics Heplisav-B (n = 1,809) Engerix-B (n = 606) Baseline Characteristic Age, mean (range), years 40 (18-55) 40 (18-55) Male, no. (%) 852 (47) 262 (43) Race, no. (%) White Black Asian Other 1,690 (93) 39 (2) 43 (2) 37 (3) 556 (92) 20 (3) 22 (4) 8 (1) Weight, mean (range), kg 80.3 (43-173) 80.8 (39-179) Body mass index, kg/m2 27.4 (15.0-58.1) 27.6 (16.4-63.2) Smoker, n (%) 654 (36) 224 (37) Source: Halperin SA, et al. Vaccine. 2012;30:2256-63.

5. Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 18-55 Years HBV-10 Trial: Results Heplisav-B Engerix-B Primary Endpoint 100 97.9 88.5 98.3 95.1 Anti-HBs 10 mIU/mL (%) 80 81.1 60 40 26.4 22.9 32.4 23.6 20 4.0 0 0 4 8 12 16 20 24 28 32 Week Heplisav-B 1 2 Engerix-B 1 2 3 Source: Halperin SA, et al. Vaccine. 2012:30:2556-63.

6. Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 18-55 Years HBV-10 Trial: Results Heplisav-B Engerix-B Primary Endpoint 100 95.1 Anti-HBs 10 mIU/mL (%) 80 81.1 60 40 20 0 0 4 8 12 16 20 24 28 32 Week Heplisav-B 1 2 Engerix-B 1 2 3 Source: Halperin SA, et al. Vaccine. 2012:30:2556-63.

7. Heplisav-B Vaccine versus Engerix-B Vaccine in Healthy Adults Aged 18-55 Years HBV-10 Trial: Conclusions Conclusions: A short, two-dose regimen of HBV-ISS induced a superior antibody response than a three-dose regimen of a licensed hepatitis B vaccine and was well tolerated. Source: Halperin SA, et al. Vaccine. 2012;30:2256-63.

8. 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)