Development and preclinical evaluation of an alphavirus replicon particle vaccine for cytomegalovirus

Vaccine. 2007 Oct 16;25(42):7441-9. doi: 10.1016/j.vaccine.2007.08.016. Epub 2007 Aug 30.

Abstract

We used a replication-incompetent, single-cycle, alphavirus replicon vector system to produce virus-like replicon particles (VRP) expressing the extracellular domain of human cytomegalovirus (CMV) glycoprotein B or a pp65/IE1 fusion protein. Efficient production methods were scaled to produce pilot lots and clinical lots of each alphavirus replicon vaccine component. The vaccine induced high-titered antibody responses in mice and rabbits, as measured by ELISA and CMV neutralization assays, and robust T-cell responses in mice, as measured by IFN-gamma ELISPOT assay. A toxicity study in rabbits showed no adverse effects in any toxicology parameter. These studies support clinical testing of this novel CMV alphavirus replicon vaccine in humans.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Alphavirus / genetics*
  • Animals
  • Antibodies, Viral / blood
  • Cytomegalovirus / genetics*
  • Cytomegalovirus / immunology*
  • Cytomegalovirus Infections / immunology
  • Cytomegalovirus Infections / prevention & control
  • Cytomegalovirus Vaccines / genetics*
  • Cytomegalovirus Vaccines / immunology
  • Cytomegalovirus Vaccines / toxicity
  • Female
  • Genetic Vectors
  • Humans
  • Immunity, Cellular
  • Male
  • Mice
  • Mice, Inbred BALB C
  • Plasmids / genetics
  • Rabbits
  • Replicon
  • Vaccines, Synthetic / genetics
  • Vaccines, Synthetic / immunology
  • Vaccines, Synthetic / toxicity

Substances

  • Antibodies, Viral
  • Cytomegalovirus Vaccines
  • Vaccines, Synthetic