VBI Vaccines Inc. announced plans for a global 15-month Phase III clinical program on Sci-B-Vac on Tuesday. The program will consist of two Phase III trials of the third-generation hepatitis B vaccine.
Approximately 4,800 participants will be enrolled in the two trials. PROTECT will enroll 1,600 adults in a study of the safety and immunogenicity of the vaccine. CONSTANT will enroll 3,200 adults between 18 and 45 in a lot-to-lot consistency study.
The trials will be conducted at 40 sites in the U.S., Canada and Europe. VBI plans to begin enrolling participants in the second half of 2017.
“We consider the outcome of discussions with the FDA, EMA, and Health Canada to be extremely positive,” VBI President and CEO Jeff Baxter said. “Sci-B-Vac’s extensive safety and efficacy data package demonstrates safe and effective vaccination of approximately 2,000 subjects in past clinical trials. Because of this track record, we are able to plan a Phase 3 program that will enroll only 4,800 subjects in total and will be only 15 months in duration.”