Safety and efficacy of mucosal immunotherapy using human papillomavirus (HPV) type 16 E7-expressing Lactobacillus-based vaccine for the treatment of high-grade squamous intraepithelial lesion (HSIL): the study protocol of a randomized placebo-controlled clinical trial (MILACLE study)-Reference-Cited by-同舟云学术

Safety and efficacy of mucosal immunotherapy using human papillomavirus (HPV) type 16 E7-expressing Lactobacillus-based vaccine for the treatment of high-grade squamous intraepithelial lesion (HSIL): the study protocol of a randomized placebo-controlled clinical trial (MILACLE study)

Published:2019-07-09 Issue:9 Volume:49 Page:877-880
ISSN:1465-3621
Container-title:Japanese Journal of Clinical Oncology
language:en
Short-container-title:

Author:

Ikeda Yuji¹,Uemura Yukari²,Asai-Sato Mikiko¹,Nakao Takehiro¹,Nakajima Takahiro¹,Iwata Takashi³,Akiyama Azusa⁴,Satoh Toyomi⁴,Yahata Hideaki⁵,Kato Kiyoko⁵,Maeda Daichi⁶,Aoki Daisuke³,Kawana Kei¹

Affiliation:

1. Department of Obstetrics and Gynecology, Nihon University School of Medicine, Tokyo

2. Biostatistics Division, Clinical Research Support Center, Graduate School of Medicine, The University of Tokyo, Tokyo

3. Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo

4. Department of Obstetrics and Gynecology, Faculty of Medicine, University of Tsukuba, Ibaraki

5. Department of Obstetrics and Gynecology, Graduate School of Medicine, Kyushu University, Fukuoka

6. Department of Clinical Genomics, Graduate School of Medicine, Osaka University, Osaka

Abstract

This is a concept paper of multicenter, placebo-controlled, double-blind randomized phase I/II trial to test the safety and efficacy of IGMKK16E7 for patients with HPV16-positive high-grade squamous intraepithelial lesion.

Funder

Japan Agency for Medical Research and Development

GLOVACC Inc

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Radiology Nuclear Medicine and imaging,Oncology,General Medicine

Link

http://academic.oup.com/jjco/article-pdf/49/9/877/30150630/hyz095.pdf

Reference14 articles.

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2. Natural history of cervicovaginal papillomavirus infection in young women;Ho;N Engl J Med,1998