Good news!
VBI Vaccines (NASDAQ:VBIV) jumps 9% premarket in reaction to the announcement that results from a Phase 4 study of prophylactic 3-antigen hepatitis B virus (HBV) vaccine in younger adults were published in Vaccine, a journal publication from Elsevier.
The study was designed to evaluate the immunogenicity of VBI’s 3-antigen HBV vaccine in support of the qualification of the batch as a new reference standard for vaccine release to the Israeli market, where its available as Sci-B-Vac.
The reference batch should elicit, a seroprotection rate (SPR) of at least 95% in young and healthy adult participants.
In this open-label, single-arm Phase 4 study in 91 healthy adults age 20-40 years, this objective was achieved two months after the second dose – the SPR at month 3 was 98.8%.
High-responder SPR was 81.4% and 97.6% at month 3 (after 2 doses) and month 7 (after 3 doses), respectively.
The geometric mean concentration of anti-HBs titers were also substantially above the protective threshold at 413.6 mIU/mL and 6799.9 mIU/mL at month 3 and month 7, respectively.
Anti-HBs titers were maintained above 2000 mIU/mL at month 12, suggesting a potent and sustained response.
Consistent with other clinical data, VBI’s 3-antigen HBV vaccine was well-tolerated with no safety signals observed.