As promised last year during its merger with Scivac Therapeutics Inc., VBI Vaccines Inc. is seeking to move Sci-B-Vac, a third-generation hepatitis B virus (HBV) vaccine licensed in Israel and 14 other countries, onto the world stage. After gathering input from the FDA, EMA and Health Canada, the Cambridge, Mass.-based company is preparing to conduct a 15-month phase III program that will include two concurrent studies – the safety and immunogenicity PROTECT study and lot-to-lot consistency CONSTANT study – with combined enrollment of approximately 4,800 participants across some 40 sites in the U.S., Europe and Canada.