General Information

PreHevbrio [Hepatitis B Vaccine (Recombinant)] induces antibodies to 3 HBV surface antigens. 

PreHevbrio is specifically indicated for use in adults for the prevention of infection caused by all known subtypes of hepatitis B virus.

PreHevbrio is supplied as a suspension for intramuscular injection. Administer a series of three doses (1.0 mL each) on a 0-, 1- and 6-month schedule

Mechanism of Action

PreHevbrio [Hepatitis B Vaccine (Recombinant)] induces antibodies to 3 HBV surface antigens: the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface antigens. 

Side Effects

Adverse effects associated with the use of PreHevbrio may include, but are not limited to, the following:

• injection site pain and tenderness
• headache
• fatigue
• myalgia

Clinical Trial Results

FDA Approval was based on the results from two Phase 3 clinical studies, PROTECT and CONSTANT, which compared PreHevbrio to Engerix-B, a single-antigen HBV vaccine. Data from the PROTECT study showed that PreHevbrio elicited higher rates of seroprotection in all subjects age 18+ (91.4% vs. 76.5%), including in adults age 45+ (89.4% vs. 73.1%).  In the CONSTANT study seroprotection after two doses, at Day 168, was 90.4% for VBI’s 3-antigen vaccine candidate compared to 51.6% for Engerix-B, increasing to 99.3% and 94.8%, respectively, after the third dose.