title: A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial.
abstract: BACKGROUND
  West Nile virus (WNV) is a mosquito-borne flavivirus that can cause severe meningitis and encephalitis in infected individuals. We report the safety and immunogenicity of a WNV DNA vaccine in its first phase 1 human study.
  
  
  METHODS
  A single-plasmid DNA vaccine encoding the premembrane and the envelope glycoproteins of the NY99 strain of WNV was evaluated in an open-label study in 15 healthy adults. Twelve subjects completed the 3-dose vaccination schedule, and all subjects completed 32 weeks of evaluation for safety and immunogenicity. The development of a vaccine-induced immune response was assessed by enzyme-linked immunosorbant assay, neutralization assays, intracelluar cytokine staining, and enzyme-linked immunospot assay.
  
  
  RESULTS
  The vaccine was safe and well tolerated, with no significant adverse events. Vaccine-induced T cell and antibody responses were detected in the majority of subjects. Neutralizing antibody to WNV was detected in all subjects who completed the 3-dose vaccination schedule, at levels shown to be protective in studies of horses, an incidental natural host for WNV.
  
  
  CONCLUSIONS
  Further assessment of this DNA platform for human immunization against WNV is warranted.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT00106769 .
authors.affiliation: Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 40 Convent Drive, Bethesda, MD 20892, USA.
authors.forename: Julie E
authors.initials: JE
authors.lastname: Martin
authors.forename: Theodore C
authors.initials: TC
authors.lastname: Pierson
authors.forename: Sarah
authors.initials: S
authors.lastname: Hubka
authors.forename: Steve
authors.initials: S
authors.lastname: Rucker
authors.forename: Ingelise J
authors.initials: IJ
authors.lastname: Gordon
authors.forename: Mary E
authors.initials: ME
authors.lastname: Enama
authors.forename: Charla A
authors.initials: CA
authors.lastname: Andrews
authors.forename: Qing
authors.initials: Q
authors.lastname: Xu
authors.forename: Brent S
authors.initials: BS
authors.lastname: Davis
authors.forename: Martha
authors.initials: M
authors.lastname: Nason
authors.forename: Michael
authors.initials: M
authors.lastname: Fay
authors.forename: Richard A
authors.initials: RA
authors.lastname: Koup
authors.forename: Mario
authors.initials: M
authors.lastname: Roederer
authors.forename: Robert T
authors.initials: RT
authors.lastname: Bailer
authors.forename: Phillip L
authors.initials: PL
authors.lastname: Gomez
authors.forename: John R
authors.initials: JR
authors.lastname: Mascola
authors.forename: Gwong-Jen J
authors.initials: GJ
authors.lastname: Chang
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Nabel
authors.forename: Barney S
authors.initials: BS
authors.lastname: Graham
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis* / Q000276:immunology; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013601:T-Lymphocytes / Q000276:immunology; D019444:Vaccines, DNA / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use* / Q000821:virology; D014901:West Nile Fever / Q000517:prevention & control* / Q000821:virology; D053060:West Nile Virus Vaccines / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use*; D014902:West Nile virus / Q000235:genetics / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D019444:Vaccines, DNA; D053060:West Nile Virus Vaccines