VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) today announced that, following a review of safety data from the limited safety immunization period, the Data Safety Monitoring Board (“DSMB”) has no objection to VBI continuing with the enrollment of participants across all sites and dose groups in the Phase I clinical study to evaluate its preventative cytomegalovirus (“CMV”) vaccine candidate.
“We are grateful to the DSMB for their oversight of this study and pleased to continue enrollment as planned,” said Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “We are encouraged by the progress we are making in the Phase I trial, which is expected to last 20 months with preliminary results anticipated in the first half of 2017.”
The Phase I study is designed to assess the safety and tolerability of VBI’s CMV vaccine candidate in approximately 125 healthy CMV-negative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection. VBI will continue to share clinical trial safety data with Health Canada periodically throughout the study. Additional information, including a detailed description of the study design, eligibility criteria, and investigator sites, is available at ClinicalTrials.gov using identifier NCT02826798.
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 retardation1. CMV affects more live births than Down syndrome or fetal alcohol syndrome2, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement3.
“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.”
To learn more about VBI’s CMV vaccine program, visit: https://www.vbivaccines.com/cmv/