JPRN-jRCT2031190034已完成1 期
A Phase I/II study of mucosal immunotherapy using HPV-targeting Lactobacillus-based vaccine, IGMKK16E7, for treatment of HPV16-related high-grade squamous intraepithelial lesions: MILACLE study - MILACLE study
Kawana Kei0 个研究点目标入组 165 人开始时间: 2019年5月31日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
研究概览
简要总结
In a double-blind, placebo-controlled, randomized trial, 165 patients with HPV16-positve high-grade cervical intraepithelial neoplasia (CIN2/3) were assigned to orally-administered placebo, or low-, intermediate-, or high-doses of IGMKK16E7 (lacticaseibacillus paracasei expressing cell surface, full-length HPV16E7). In all four groups, IGMKK16E7 or placebo was administered orally at weeks 1, 2, 4 and 8 post-enrollment. The primary outcomes included histopathological regression and IGMKK16E7 safety.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 45age old（—）
- 性别
- Female
入选标准
- •20-45 years-old health female who are diagnosed as HSIL/CIN2 and HSIL/CIN3 by histological examination and infected with HPV 16 alone or HPV16+other types.
排除标准
- •(1) Immune compromised host or person who receive immunosuppressive therapy,
- •(2) Patients who is suspected as invasive cancer,
- •(3) Patients who has a previous history of hypersensitivity to Lactobacillus-content food/drug or milk,
- •(4) Pregnant women or patients who expected to get pregnant,
- •(5) Breast feeder mother.
研究者
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