The Food and Drug Administration (FDA) has approved PreHevbrio™ (hepatitis B vaccine [recombinant]) for the prevention of infection caused by all known subtypes of hepatitis B virus (HBV) in adults 18 year of age and older.
PreHevbrio contains the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface antigens. The approval was based on data from 2 randomized, double-blind phase 3 studies, PROTECT (CinicalTrials.gov Identifier: NCT03393754) and CONSTANT (CinicalTrials.gov Identifier: NCT03408730), which compared the safety and immunogenicity of the vaccine candidate to Engerix-B® in individuals 18 years of age and older. Participants were randomly assigned to receive either 10µg of PreHevbrio or Engerix-B intramuscularly on a 0-, 1- and 6-month schedule.
In the PROTECT study (N=1441), results showed that PreHevbrio demonstrated noninferiority with a seroprotection rate (SPR) of 91.4% (95% CI, 89.1-93.3) compared with 76.5% (95% CI, 73.2-79.5) for Engerix-B (SPR difference: 14.9%; 95% CI, 11.2-18.6). Among participants aged 45 years and older, SPR was 89.4% (95% CI, 86.8-91.7) with PreHevbrio compared with 73.1% (95% CI, 69.4-76.5) with Engerix-B (SPR difference: 16.4%; 95% CI, 12.2-20.7).
In the CONSTANT study (N=2345), PreHevbrio demonstrated noninferiority with an SPR of 99.3% (95% CI 98.7-99.6) after the 3-dose series compared with 94.8% (95% CI, 92.7-96.4) for Engerix-B (SPR difference: 4.5%; 95% CI, 2.9-6.6).
The most common local reactions with PreHebvrio were injection site pain and tenderness, while systemic reactions included headache, fatigue, and myalgia.
PreHevbrio is supplied in a single-dose vial (1.0mL). The vaccine is administered as a 3-dose series (each 1.0mL) via intramuscular injection on a 0-, 1- and 6-month schedule. The product is expected to be available in the first quarter of 2022.
- VBI Vaccines announces FDA approval of PreHevbrio™ for the prevention of hepatitis B in adults. News release. VBI Vaccines Inc. Accessed December 1, 2021. https://www.businesswire.com/news/home/20211201005387/en/VBI-Vaccines-Announces-FDA-Approval-of-PreHevbrio%E2%84%A2-for-the-Prevention-of-Hepatitis-B-in-Adults.
- PreHevbrio. Package insert. VBI Vaccines Inc.; 2021. Accessed December 1, 2021. https://www.prehevbrio.com/wp-content/uploads/2021/11/PreHevbrio-Full-Prescribing-Information.pdf.