title: VCL-CB01, an injectable bivalent plasmid DNA vaccine for potential protection against CMV disease and infection.
abstract: Vaccines for the prevention of human CMV (hCMV) infection and disease are a major public health priority. Immunization with DNA vaccines encoding key proteins involved in the immune response to hCMV has emerged as a major focus of hcmv vaccine research. Validation of the protective effect of DNA vaccination in animal models has provided support for clinical trials. VCL-CB01, under development by Vical Inc for the prevention of hCMV infection and disease, is a poloxamer-formulated, bivalent DNA vaccine that contains plasmids encoding hCMV tegument phosphoprotein 65 and the major hCMV surface glycoprotein B. In a phase I trial in healthy adults, VCL-CB01 was well tolerated. In interim results from a phase II trial in hCMV-seropositive hematopoietic cell transplant recipients, VCL-CB01 increased T-cell responses compared with placebo. The final results from the phase II trial will be of value for developing strategies to prevent hCMV disease in hCMV-seropositive transplant recipients, and may lead to other trials of VCL-CB01 or related vaccines for the prevention of congenital hCMV infection.
authors.affiliation: University of Minnesota, Center for Infectious Diseases and Microbiology Translational Research, Department of Pediatrics, Minneapolis, MN 55455, USA. schleiss@umn.edu
authors.forename: Mark R
authors.initials: MR
authors.lastname: Schleiss
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D003587:Cytomegalovirus / Q000276:immunology*; D003586:Cytomegalovirus Infections / Q000276:immunology* / Q000517:prevention & control / Q000821:virology; D022482:Cytomegalovirus Vaccines / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D010330:Patents as Topic; D010957:Plasmids / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology*
chemical_list: D022482:Cytomegalovirus Vaccines; C547023:VCL-CB01 vaccine; D019444:Vaccines, DNA