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

作者：Dutton Julie L; Woo Wai Ping; Chandra Janin; Xu Yan; Li Bo; Finlayson Neil; Griffin Paul; Frazer Ian H^*

来源：Human Vaccines & Immunotherapeutics, 2016, 12(12): 3079-3088.

DOI：10.1080/21645515.2016.1221872

• codon-modification
• DNA vaccine
• Genital herpes
• healthy volunteers
• HSV-2
• polynucleotide vaccine
• ubiquitination

This paper describes a single site, open-label Phase I clinical trial evaluting 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.

• 出版日期2016