VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) today announced that it has completed enrollment and initial dosing of all participants in the Phase I clinical study to evaluate its preventative cytomegalovirus (“CMV”) vaccine candidate.
The Phase I study is designed to assess the safety and tolerability of VBI’s CMV vaccine candidate in 128 healthy CMV-negative adults. The study will also measure levels of vaccine-induced CMV neutralizing antibodies that may prevent CMV infection. Preliminary results are anticipated in the first half of 2017.
“The completion of enrollment is an important milestone for VBI,” said Dr. Francisco Diaz-Mitoma, M.D., Ph.D., VBI’s Chief Medical Officer. “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. Naturally acquired CMV immunity may provide up to 90% protection from congenital CMV transmission1, 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 have been 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. 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 retardation2. CMV affects more live births than Down syndrome or fetal alcohol syndrome3, making it a key public health priority and a strong candidate for recommended universal vaccination and reimbursement4.
“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/