VBI Vaccines has been recommended to continue enrolling patients for its Phase I clinical study in order to evaluate its preventative cytomegalovirus (CMV) vaccine candidate.
The company is developing a prophylactic vaccine to prevent CMV infection, which is the main cause of prenatal developmental delays.
The recommendation was made by an independent Data Safety Monitoring Board (DSMB) after completing an analysis of safety data from the limited safety immunisation period.
The trial has been designed to evaluate safety, tolerability, and also immunological proof of concept in humans by measuring CMV neutralising antibodies in fibroblasts and epithelial cells.
It involves nearly 125 healthy CMV-negative adults who are administered with the vaccine candidate. The study will also measure levels of vaccine-induced CMV neutralising antibodies that may prevent CMV infection.
VBI Vaccines chief medical officer Dr. Francisco Diaz-Mitoma said: “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.”
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The company anticipates the prophylactic CMV vaccine market to exceed $1bn annually. Figures released by the company show that the demand for a CMV vaccine could exceed 7.6 million doses by 2030.
VBI president and CEO Jeff Baxter said: “Congenital CMV infection is a leading cause of serious birth defects in the US and globally.
“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.”