An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1

Dutton, Julie L., Woo, Wai-Ping, Chandra, Janin, Xu, Yan, Li, Bo, Finlayson, Neil, Griffin, Paul and Frazer, Ian H. (2016) An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1. Human Vaccines and Immunotherapeutics, 12 12: 3079-3088. doi:10.1080/21645515.2016.1221872


Author Dutton, Julie L.
Woo, Wai-Ping
Chandra, Janin
Xu, Yan
Li, Bo
Finlayson, Neil
Griffin, Paul
Frazer, Ian H.
Title An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1
Journal name Human Vaccines and Immunotherapeutics   Check publisher's open access policy
ISSN 2164-5515
2164-554X
Publication date 2016-08-31
Year available 2016
Sub-type Article (original research)
DOI 10.1080/21645515.2016.1221872
Open Access Status Not yet assessed
Volume 12
Issue 12
Start page 3079
End page 3088
Total pages 34
Place of publication New York, United States
Publisher Taylor & Francis
Language eng
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.
Keyword Genital herpes
HSV-2
Polynucleotide vaccine
DNA vaccine
Healthy volunteers
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ
Additional Notes Published online 31 August 2016. Epub ahead of print

 
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Created: Thu, 10 Nov 2016, 21:24:36 EST by Paul Griffin on behalf of Mater Research Institute-UQ