The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for VBI Vaccines’ 3-antigen prophylactic hepatitis B vaccine candidate for the prevention of infection caused by all known subtypes of the hepatitis B virus (HBV) in adults.

The vaccine candidate consists of the S, pre-S1, and pre-S2 surface antigens of the hepatitis B virus. The BLA is supported by data from 2 randomized, double-blind phase 3 studies, PROTECT (N=1607) and CONSTANT (N=2838), which compared the safety and immunogenicity of the vaccine candidate to Engerix-B® in patients 18 years of age and older.

Patients were randomly assigned to receive prophylactic hepatitis B vaccination with either 10µg of the vaccine candidate intramuscularly (IM) or Engerix-B IM on days 0, 28, and 168. 

In the PROTECT study, results showed that among the entire study population, a seroprotection rate (SPR) of 91.4% was observed in the vaccine candidate arm vs 76.5% for the Engerix-B arm (SPR difference: 14.9%; 95% CI, 11.2-18.6). In patients aged 45 years and older, SPR was 89.4% with the vaccine candidate compared with 73.1% with Engerix-B (SPR difference: 16.4%; 95% CI, 12.2-20.7).


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In the CONSTANT study, the vaccine candidate demonstrated noninferiority with an SPR of 99.3% and 90.4% after 3 and 2 doses, respectively, compared with 94.8% and 51.6% for Engerix-B, respectively. Additionally, the vaccine candidate demonstrated lot-to-lot consistency.

“The FDA acceptance of our BLA represents a significant milestone for VBI, but more importantly for the effort to provide broad access to this vaccine, which we believe has the potential to be a meaningful intervention for adults in the fight against hepatitis B,” said Jeff Baxter, President & CEO.

A Prescription Drug User Fee Act (PDUFA) target date of November 30, 2021 has been set for this application.

Reference

  1. VBI vaccines announces U.S. FDA acceptance of BLA filing for VBI’s 3-antigen prophylactic hepatitis B vaccine. [press release]. Cambridge, MA: VBI Vaccines Inc.; February 2, 2021. 
  2. VBI vaccines announces second pivotal phase 3 study of Sci-B-Vac® meets primary and secondary endpoints. [press release]. Cambridge, MA: VBI Vaccines Inc.; January 9, 2020. 

This article originally appeared on MPR