VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) has received a No Objection Letter from Health Canada, providing clearance to begin enrolling Canadian participants in a Phase I clinical study to evaluate VBI’s preventative cytomegalovirus (“CMV”) vaccine candidate in humans.

CMV can cause serious disease in newborns when a mother is infected during pregnancy. Each year, approximately 5,000 U.S. infants will develop permanent problems due to CMV, which can include deafness, blindness, and mental retardation.1 CMV affects more live births than Down syndrome or fetal alcohol syndrome,2 making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement.3

“Congenital CMV infection is a leading cause of serious birth defects in the U.S. and globally,” said Jeff Baxter, VBI’s President and CEO. “Each year, thousands of newborns and their families are impacted by this devastating disease. We believe that developing a vaccine to prevent CMV offers the best chance of substantially eliminating congenital CMV infection and the resulting birth defects; advancing our vaccine candidate into a human clinical trial is a significant step forward in this effort.”

The Phase I study is designed to assess the safety and tolerability of VBI’s eVLP Platform-derived cytomegalovirus vaccine candidate in approximately 125 healthy CMV-seronegative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection.

“While safety and tolerability are our primary endpoints, we will also measure the immune response generated by our CMV vaccine candidate, and compare it to persons with naturally acquired CMV immunity,” said Dr. David E. Anderson, VBI’s Chief Scientific Officer. “Naturally acquired CMV immunity may provide up to 90% protection from congenital CMV transmission,4 providing a benchmark for our Phase I study that could allow for human immunological proof of concept at an early stage of clinical development.”

Study participants will be split into five groups that will receive three varying doses of VBI’s adjuvanted vaccine candidate, an unadjuvanted version of the vaccine candidate, or a placebo control, at zero, two, and six months. The study is expected to last 20 months with an interim readout anticipated in H1 2017 following administration of the second vaccination. Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, will be made available at ClinicalTrials.gov.