free web stats

VBI’s CMV Vaccine Candidate Design and Preclinical Data

By August 8, 2014Cytomegalovirus ("CMV")

Dr. David E. Anderson, VBI’s Senior Vice President of Research, discusses how eVLPs, and an optimized form of the CMV gB antigen, can be used to develop a potentially efficacious CMV vaccine.

VBI is developing a prophylactic vaccine to prevent Cytomegalovirus (CMV) infection. CMV is a leading cause of prenatal developmental delays and causes more long-term problems and childhood deaths than Down Syndrome or Fetal Alcohol Syndrome.1 In the U.S., congenital CMV causes one child to become disabled every hour,2 making it a key public health priority.3 Primary CMV infection can also cause serious disease in organ and bone marrow transplant recipients, cancer patients, and patients receiving immunosuppressive drugs.4

VBI’s CMV vaccine candidate (VBI-1501A) uses enveloped virus-like particle technology to present a modified gB antigen, a major target of neutralizing antibodies, in a lipid bilayer which surrounds a stable, protein-based core. A stabilizing adjuvant (alum) is then added to promote a longer-lasting immune response.

To date, animal studies have demonstrated that VBI-1501A can:

  • Neutralize the CMV virus in two cell types (fibroblast and epithelial) infected by the CMV virus.5
  • Create long-lasting immunity.6
  • Induce an immune response significantly more potent than both naturally acquired immunity and that elicited by immunizing with the target protein (gB) alone.7

Based on preclinical data, VBI has initiated work for GMP manufacturing of its lead candidate for use in clinical trials, expected to begin by the end of 2015.

Sources

  1. Cannon, M. J., and K. F. Davis. 2005. Washing our hands of the congenital cytomegalovirus disease epidemic. BMC Public Health 5:70
  2. http://www.cdc.gov/CMV/index.html
  3. Stratton KR et al, Committee to Study Priorities for Vaccine Development, Inst. of Med.; Washington, DC
  4. http://www.cdc.gov/CMV/risk/weak-immune.html
  5. VBI Studies: 15BC04, 15BC19, 15BC39
  6. VBI Studies: 15BC19
  7. VBI Studies: 15BC04, 15BC19