- Patient dosing commenced on December 18, 2017
- 4,800 subjects across two Phase 3 studies: PROTECT and CONSTANT
- 15-month program - headline data expected Q2 2019
About PROTECT - Safety and Immunogenicity StudyPROTECT will be a double-blind, two-arm, randomized, controlled study. Approximately 1,600 adult subjects, 18 years of age and older, will be randomized in a 1:1 ratio to receive either a three-dose course of Sci-B-Vac 10µg or a three-dose course of the control vaccine, Engerix-B® 20µg. Enrollment will be stratified by age group. The co-primary objectives of the study will be:
- To demonstrate non-inferiority of the seroprotection rate induced by Sci-B-Vac vs. Engerix-B® four weeks after the third vaccination in adults age 18 and older.
- To demonstrate superiority of the seroprotection rate induced by Sci-B-Vac vs. Engerix-B® four weeks after the third vaccination in adults older than 45 years of age.
- To demonstrate lot-to-lot consistency for immune response as measured by geometric mean concentration (GMC) of antibodies across three independent, consecutive lots of Sci-B-Vac four weeks after the third vaccination.