An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1
An escalating dose study to assess the safety, tolerability and immunogenicity of a Herpes Simplex Virus DNA vaccine, COR-1
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DOI：
10.1080/21645515.2016.1221872
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发表时间：
2016-01-01
影响因子：
4.8
通讯作者：
Frazer, Ian H.
中科院分区：
文献类型：
--
作者：
Dutton, Julie L.;Woo, Wai-Ping;Frazer, Ian H.
本文描述了一个单一的网站，开放标签的I期临床试验，评估的安全性，耐受性和免疫原性在健康志愿者的单纯疱疹病毒多核苷酸疫苗，以前已被证明可以提高免疫原性，并防止致命的单纯疱疹病毒2型（HSV-2）的挑战小鼠。通过皮内注射对HSV-1和2名血清阴性健康个体给予5个递增剂量的疫苗COR-1。COR-1被发现是安全和耐受性良好的;唯一的疫苗相关不良事件是轻微的。虽然未检测到疫苗诱导的抗体应答，但在完成研究的20名受试者中的19名中鉴定了对HSV特异性肽组的细胞介导的免疫应答，并观察到免疫部位的局部炎症。这项研究表明COR-1有可能作为HSV-2感染的治疗性疫苗。
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.