title: Safety and immunogenicity of a bivalent cytomegalovirus DNA vaccine in healthy adult subjects.
abstract: BACKGROUND
  VCL-CB01, a candidate cytomegalovirus (CMV) DNA vaccine that contains plasmids encoding CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) to induce cellular and humoral immune responses and that is formulated with poloxamer CRL1005 and benzalkonium chloride to enhance immune responses, was evaluated in a phase 1 clinical trial.
  
  
  METHODS
  VCL-CB01 was evaluated in 44 healthy adult subjects (22 CMV seronegative and 22 CMV seropositive) 18-43 years old. Thirty-two subjects received 1- or 5-mg doses of vaccine on a 0-, 2-, and 8-week schedule, and 12 subjects received 5-mg doses of vaccine on a 0-, 3-, 7-, and 28-day schedule.
  
  
  RESULTS
  Overall, the vaccine was well tolerated, with no serious adverse events. Local reactions included mild to moderate injection site pain and tenderness, induration, and erythema. Systemic reactions included mild to moderate malaise and myalgia. All reactions resolved without sequelae. Through week 16 of the study, immunogenicity, as measured by enzyme-linked immunosorbant assay and/or ex vivo interferon (IFN)-gamma enzyme-linked immunospot assay, was documented in 45.5% of CMV-seronegative subjects and in 25.0% of CMV-seropositive subjects who received the full vaccine series, and 68.1% of CMV-seronegative subjects had memory IFN-gamma T cell responses at week 32.
  
  
  CONCLUSIONS
  The safety and immunogenicity data from this trial support further evaluation of VCL-CB01.
authors.affiliation: Vical, Inc., San Diego, CA 92121, USA. mwloch@vical.com
authors.forename: Mary K
authors.initials: MK
authors.lastname: Wloch
authors.forename: Larry R
authors.initials: LR
authors.lastname: Smith
authors.forename: Souphaphone
authors.initials: S
authors.lastname: Boutsaboualoy
authors.forename: Luane
authors.initials: L
authors.lastname: Reyes
authors.forename: Christina
authors.initials: C
authors.lastname: Han
authors.forename: Jackie
authors.initials: J
authors.lastname: Kehler
authors.forename: Heather D
authors.initials: HD
authors.lastname: Smith
authors.forename: Linda
authors.initials: L
authors.lastname: Selk
authors.forename: Ryotaro
authors.initials: R
authors.lastname: Nakamura
authors.forename: Janice M
authors.initials: JM
authors.lastname: Brown
authors.forename: Thomas
authors.initials: T
authors.lastname: Marbury
authors.forename: Anna
authors.initials: A
authors.lastname: Wald
authors.forename: Alain
authors.initials: A
authors.lastname: Rolland
authors.forename: David
authors.initials: D
authors.lastname: Kaslow
authors.forename: Thomas
authors.initials: T
authors.lastname: Evans
authors.forename: Michael
authors.initials: M
authors.lastname: Boeckh
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood*; D003587:Cytomegalovirus / Q000276:immunology; D022482:Cytomegalovirus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006801:Humans; D007156:Immunologic Memory; D007700:Kinetics; D008297:Male; D013601:T-Lymphocytes / Q000502:physiology; D013997:Time Factors; D019444:Vaccines, DNA / Q000009:adverse effects* / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D022482:Cytomegalovirus Vaccines; D019444:Vaccines, DNA