A Phase II, Prospective, Randomized, Multicenter, Open-Label Study of GX-188E, an HPV DNA Vaccine, in Patients with Cervical Intraepithelial Neoplasia 3

A Phase II, Prospective, Randomized, Multicenter, Open-Label Study of GX-188E, an HPV DNA Vaccine, in Patients with Cervical Intraepithelial Neoplasia 3
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DOI:
10.1158/1078-0432.ccr-19-1513
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发表时间:
2020-04-01
影响因子:
11.5
通讯作者:
Park, Jong Sup
Park, Jong Sup
中科院分区:
医学1区
文献类型:
--
作者:
Choi, Youn Jin;Hur, Soo Young;Park, Jong Sup

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目的:确定治疗性DNA疫苗GX-188 E诱导宫颈上皮内瘤变(CIN)消退的疗效3.患者和方法:我们在人乳头瘤病毒(HPV)16/18型阳性的CIN 3患者中进行了一项GX-188 E的前瞻性、随机、多中心、开放标签、II期临床试验。主要终点是确定组织病理学消退,
Purpose: To determine the efficacy of the therapeutic DNA vaccine GX-188E for inducing regression of cervical intraepithelial neoplasia (CIN) 3.Patients and Methods: We conducted a prospective, randomized, multicenter, open-label, phase II clinical trial of GX-188E in CIN3 patients positive for human papillomavirus (HPV) type 16/18. The primary endpoint was to determine the histopathologic regression to