title: An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1.
abstract: This paper describes a single site, open-label Phase I clinical trial evaluating the safety, tolerability and immunogenicity in healthy volunteers of a herpes simplex polynucleotide vaccine that has previously been shown to enhance immunogenicity and protect against lethal herpes simplex virus type 2 (HSV-2) challenge in mice. Five escalating doses of the vaccine, COR-1, were given by intradermal injection to HSV-1 and 2 seronegative healthy individuals. COR-1 was found to be safe and well-tolerated; the only vaccine-related adverse events were mild. While vaccine-induced antibody responses were not detectable, cell-mediated immune responses to HSV-specific peptide groups were identified in 19 of the 20 subjects who completed the study, and local inflammation at the immunisation site was observed. This study indicates COR-1 has potential to be used as a therapeutic vaccine for HSV-2 infection.
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.|b University of Queensland , Diamantina Institute, Translational Research Institute , Woolloongabba , QLD, Australia.
authors: Julie L
authors: JL
authors: Dutton
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.|b University of Queensland , Diamantina Institute, Translational Research Institute , Woolloongabba , QLD, Australia.
authors: Wai-Ping
authors: WP
authors: Woo
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.|b University of Queensland , Diamantina Institute, Translational Research Institute , Woolloongabba , QLD, Australia.
authors: Janin
authors: J
authors: Chandra
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.|b University of Queensland , Diamantina Institute, Translational Research Institute , Woolloongabba , QLD, Australia.
authors: Yan
authors: Y
authors: Xu
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.|b University of Queensland , Diamantina Institute, Translational Research Institute , Woolloongabba , QLD, Australia.
authors: Bo
authors: B
authors: Li
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.
authors: Neil
authors: N
authors: Finlayson
authors: c Q-Pharm Pty Ltd, Brisbane, Australia; Department of Medicine and Infectious Diseases, Mater Hospital and Mater Medical Research Institute, Brisbane, Australia; The University of Queensland , Brisbane , Australia.
authors: Paul
authors: P
authors: Griffin
authors: a Admedus Vaccines Pty Ltd (formerly Coridon Pty Ltd) , Translational Research Institute , Woolloongabba , QLD , Australia.|b University of Queensland , Diamantina Institute, Translational Research Institute , Woolloongabba , QLD, Australia.
authors: Ian H
authors: IH
authors: Frazer
mesh_terms: D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006561:Herpes Simplex / Q000517:prevention & control*; D022301:Herpes Simplex Virus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D018258:Herpesvirus 2, Human / Q000276:immunology*; D006801:Humans; D007271:Injections, Intradermal; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008297:Male; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D022301:Herpes Simplex Virus Vaccines; D019444:Vaccines, DNA
keywords: DNA vaccine; Genital herpes; HSV-2; codon-modification; healthy volunteers; polynucleotide vaccine; ubiquitination