An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1. Issue 12 (1st December 2016)

• Record Type: Journal Article
• Authors: Dutton, Julie L.; Woo, Wai-Ping; Chandra, Janin; Xu, Yan; Li, Bo; Finlayson, Neil; Griffin, Paul; Frazer, Ian H.
• Is Part Of: Human vaccines & immunotherapeutics. Volume 12:Issue 12(2016)
• Page Start: 3079
• Page End: 3088
• Publication Date: 2016-12-01
• Subjects: codon-modification -- DNA vaccine -- Genital herpes -- healthy volunteers -- HSV-2 -- polynucleotide vaccine -- ubiquitination; Vaccines -- Periodicals; 615.372
• DOI: 10.1080/21645515.2016.1221872
• Languages: English
• ISSNs: 2164-5515

Abstract

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.