CVI Accepts, published online ahead of print on 19 March 2008

This Article Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Reprints and Permissions Copyright Information Books from ASM Press MicrobeWorld Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Koelle, D. M. Articles by Wald, A. Search for Related Content PubMed PubMed Citation Articles by Koelle, D. M. Articles by Wald, A.

 Previous Article  |  Next Article 

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

David M. Koelle^*, Amalia Magaret, Christopher L. McClurkan, Michael L. Remington, Terri Warren, Florentina Teofilovici, and Anna Wald

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.

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.