VBI starts Phase III lot consistency trial of HBV vaccine

VBI Vaccines Inc. (NASDAQ:VBIV) began the double-blind, international Phase III CONSTANT trial to evaluate lot-to-lot consistency of Sci-B-Vac to prevent HBV infection.

The study will enroll 3,200 adults to receive a three-dose course from one of three separate lots of 10 μg Sci-B-Vac or control vaccine Engerix-B from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). The primary endpoint will assess lot-to-lot consistency of immune response across lots as measured by geometric mean concentration of antibodies after the third dose. Secondary endpoints will assess safety...