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Clin. Vaccine Immunol. doi:10.1128/CVI.00020-08
Copyright (c) 2008, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Phase I dose-escalation study of a monovalent heat shock protein 70-herpes simplex virus type 2 peptide-based vaccine designed to prime or boost CD8 T-cell responses in HSV-naïve or HSV-2-infected subjects

Department of Medicine, University of Washington, Seattle, WA 98195; Department of Laboratory Medicine, University of Washington, Seattle, WA 98195; Department of Global Health Medicine, University of Washington, Seattle, WA 98195; Benaroya Research Institute, Seattle, WA 98101; Fred Hutchinson Cancer Research Center, Seattle, WA 98109; Westover Heights Clinic, Portland, Oregon, 97210; Department of Epidemiology, University of Washington, Seattle, WA 98195; Antigenics, Inc. Lexington, MA 02421

^* To whom correspondence should be addressed. Email: viralimm{at}u.washington.edu.

	Abstract

This was a phase I study to assess the safety, tolerability, and immunogenicity of escalating doses of AG-702, a non-covalent complex of a HLA A*0201-restricted epitope in the glycoprotein B protein of HSV-2 (gB2) and truncated human constitutive heat shock protein 70. Similarly vaccines have been immunogenic in animals. Three injections of 10 to 250 micrograms were administered intradermally to HLA A*0201-bearing subjects who were either HSV-2-infected or HSV-uninfected. 62 participants received vaccine; 60 completed the protocol and 56 accrued T-cell data. The vaccine was safe and well tolerated. New or boosted responses to the HSV-2 CD8 epitope were not detected. Baseline responses to an epitope in VP 13/14 were higher than were responses to the gB2 epitope. A heat shock protein vaccine with an HSV-2 peptide appears safe at the doses studied in healthy adults with or without HSV infection. Modifications of dose, adjuvant, route, schedule, or HSV antigen may be required to improve responses.