VBI-1501 is a prophylactic vaccine candidate to prevent cytomegalovirus (“CMV”) infection.
CMV is a leading cause of prenatal developmental delays.
VBI recently completed a Phase I trial that evaluated safety, tolerability, and also immunological proof of concept in humans by measuring CMV neutralizing antibodies in fibroblasts and epithelial cells.
VBI-1501 is administered as an intramuscular injection on Days 0, 56, and 168.
VBI’s eVLP Platform allows for the design of enveloped (“e”) virus-like particle (“VLP”) vaccines.
eVLPs are an innovative new class of synthetic vaccines that are designed to closely mimic the structure of viruses.
Because of their structural similarity to viruses found in nature, vaccination with a target protein expressed in an eVLP is capable of imparting greater immunity than vaccination with the same recombinant target protein alone.
Structure of the eVLP platform generates stronger neutralizing antibodies than does immunization with the same (gB) target protein alone.
gB antigen is a major antigen for the induction of neutralizing antibodies against CMV.
A Phase 2 clinical study to evaluate how higher doses of VBI-1501, which at 20μg will be 10-times higher than the highest dose tested in the Phase 1 study, may improve immune responses against CMV.
This Phase 2 study is expected to initiate enrollment around the end of 2019.
Clinical Trial NCT02826798: Phase 1 Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
This study is designed to assess safety and immunogenicity of four dose formulations of cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative volunteer participants between 18 and 40 years of age.