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VBI Vaccines (VBIV) Presents Phase 3 Sci-B-Vac(antigen HBV vaccine) Data at ID Week 2020

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Additional Information

Clinical Data The data included:
  • High anti-HBs titers: Across both the PROTECT and CONSTANT registrational Phase 3 studies, Sci-B-Vac safely elicited higher anti-HBs titers in all study subjects compared to Engerix-B, a single antigen HBV vaccine, regardless of age, gender, or underlying comorbidity.
  • PROTECT study:
    • In all study subjects, adults ≥ 18 years, Sci-B-Vac induced a Geometric Mean Concentration (GMC) of anti-HBs titers that was 6x higher than that induced by Engerix-B (1,148 mIU/mL vs. 193 mIU/mL)
    • The increase was sustained across key study subgroups, where Sci-B-Vac induced GMCs of anti-HBs titers that were 4-8x higher than those induced by Engerix-B, including in older adults, diabetics, and individuals with body mass index (BMI) > 30.
  • CONSTANT study:
    • In all study subjects, adults age 18-45, after two vaccinations, Sci-B-Vac induced GMCs of anti-HBs titers across all three manufactured lots that were more than 7.5x higher than that induced by Engerix-B (112.5-124.1 mIU/mL vs. 14.98 mIU/mL)
    • These titers increased after the third vaccination, with Sci-B-Vac inducing GMCs of anti-HBs of 4,854.9-5,979.2 mIU/mL vs. 1,526.2 mIU/mL with Engerix-B
  • The e-poster data included:
    • Faster onset of seroprotection in adults age 18-45 – seroprotection rate (SPR) is defined as the percent of subjects with anti-HBs titers ≥ 10 mIU/mL:
      • In the four controlled Phase 3 studies, after two vaccinations, Sci-B-Vac achieved SPR rates of 87.2%-100% compared to 39.0%-89.4% for Engerix-B
      • In the uncontrolled Phase 4 study, Sci-B-Vac achieved a 91.9% SPR at month 2, growing to 98.8% prior to receiving the third vaccination at month 6
https://www.vbivacci...
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Catalyst Date
Occurred on:
Oct 26, 2020
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Related Keywords Sci-b-vac, Antigen Hbv