VBI Vaccines Presents Phase 3 Sci-B-Vac Data at ID Week 2020

Nachrichtenquelle: Business Wire (engl.)
26.10.2020, 13:00  |  145   |   |   

VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the presentation of two abstracts featuring data from the Phase 3 program evaluating Sci-B-Vac, the company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, in e-poster presentations at ID Week 2020, which took place October 21-25, 2020.

Poster #: 8
Title: Higher hepatitis B antibody titers induced in all adults vaccinated with a 3-antigen hepatitis B (HBV) vaccine, compared to a single-antigen HBV vaccine: results from two pivotal phase 3 double-blind, randomized studies (PROTECT and CONSTANT)

Joanne Langley, M.D., Professor of Pediatrics and Community Health and Epidemiology, CIHR-GSK Chair in Pediatric Vaccinology, Dalhousie University, and Head of the Division of Infectious Disease, IWK Health Centre, and principal investigator of the PROTECT study delivered the poster presentation.

“Currently licensed HBV vaccines such as Engerix-B have important limitations. These include reduced immunogenicity in certain subgroup populations such as adults over 45, diabetics, and persons with obesity,” said Dr. Langley. “The results from this Phase 3 clinical program clearly demonstrate Sci-B-Vac’s ability to safely induce rapid and robust immune responses in young adults, as well as in older adults and those with comorbidities – a significant improvement upon Engerix-B.”

The poster highlighted Sci-B-Vac’s ability to elicit high serum levels of HBV surface antibodies (anti-HBs titers), persistence and durability of which are believed to be dependent upon peak levels induced. 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

Poster #: 1051

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VBI Vaccines Presents Phase 3 Sci-B-Vac Data at ID Week 2020 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, today announced the presentation of two abstracts featuring data from the Phase 3 …

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