A West Nile Virus DNA Vaccine Induces Neutralizing Antibody in Healthy Adults during a Phase 1 Clinical Trial (original) (raw)

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1

Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

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Bethesda, Maryland

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Viral Pathogenesis Section, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

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Bethesda, Maryland

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Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

,

Bethesda, Maryland

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Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

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Bethesda, Maryland

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Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

,

Bethesda, Maryland

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1

Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

,

Bethesda, Maryland

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1

Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

,

Bethesda, Maryland

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,

2

Viral Pathogenesis Section, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

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Bethesda, Maryland

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Arboviral Diseases Branch, Division of Vector-Borne Infectious Diseases, National Center for Zoonotic, Vector-Borne and Enteric Diseases, Centers for Disease Control and Prevention

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Fort Collins, Colorado

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Vaccine Research Center, Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health

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Bethesda, Maryland

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Published:

15 December 2007

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Julie E. Martin, Theodore C. Pierson, Sarah Hubka, Steve Rucker, Ingelise J. Gordon, Mary E. Enama, Charla A. Andrews, Qing Xu, Brent S. Davis, Martha C. Nason, Michael P. Fay, Richard A. Koup, Mario Roederer, Robert T. Bailer, Phillip L. Gomez, John R. Mascola, Gwong-Jen J. Chang, Gary J. Nabel, Barney S. Graham, Vaccine Research Center 302 Study Team, A West Nile Virus DNA Vaccine Induces Neutralizing Antibody in Healthy Adults during a Phase 1 Clinical Trial, The Journal of Infectious Diseases, Volume 196, Issue 12, 15 December 2007, Pages 1732–1740, https://doi.org/10.1086/523650
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Abstract

Background. West Nile virus (WNV) is a mosquitoborne 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. Asingle-plasmidDNAvaccine 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.

Topic:

• cytokine
• encephalitis
• meningitis
• enzyme-linked immunosorbent assay
• immune response
• glycoproteins
• adult
• antibody formation
• dna
• flavivirus
• equus caballus
• immunization
• immunization schedule
• safety
• t-lymphocytes
• vaccines
• dna vaccines
• west nile virus
• enzymes
• neutralizing antibodies
• adverse event
• neutralization
• host (organism)
• immunogenicity

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