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J Infect Dis. 2007 Dec 15;196(12):1732-40. doi: 10.1086/523650.

A West Nile virus DNA vaccine induces neutralizing antibody in healthy adults during a phase 1 clinical trial.

Author information

1
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.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier: NCT00106769 .

PMID:
18190252
PMCID:
PMC2714735
DOI:
10.1086/523650
[Indexed for MEDLINE]
Free PMC Article

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