A randomized open-label clinical trial of an anti-HPV biological dressing (JB01-BD) administered intravaginally to treat high-risk HPV infection

Xuetao Guo; Lixia Qiu; Yue Wang; Yonghong Wang; Qian Wang; Lei Song; Yali Li; Ke Huang; Xinxin Du; Wensheng Fan; Shufang Jiang; Qianqing Wang; Haoyang Li; Yi Yang; Yuanguang Meng; Yun Zhu; Lu Lu; Shibo Jiang

doi:10.1016/j.micinf.2015.10.004

A randomized open-label clinical trial of an anti-HPV biological dressing (JB01-BD) administered intravaginally to treat high-risk HPV infection

Microbes Infect. 2016 Feb;18(2):148-52. doi: 10.1016/j.micinf.2015.10.004. Epub 2015 Oct 24.

Authors

Xuetao Guo¹, Lixia Qiu², Yue Wang³, Yonghong Wang⁴, Qian Wang⁵, Lei Song³, Yali Li³, Ke Huang³, Xinxin Du³, Wensheng Fan³, Shufang Jiang³, Qianqing Wang⁶, Haoyang Li⁵, Yi Yang⁷, Yuanguang Meng³, Yun Zhu⁸, Lu Lu⁵, Shibo Jiang⁹

Affiliations

¹ First Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China.
² Shanxi Medical University, Shanxi 030001, China.
³ Chinese PLA General Hospital, Beijing 100036, China.
⁴ Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China.
⁵ Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Public Health Clinical Center and Shanghai Medical College, Fudan University, Shanghai 200032, China.
⁶ Xinxiang Central Hospital Affiliated with Medical School, Henan 453000, China.
⁷ Department of Obstetrics and Gynecology, Peking Union Medical College Hospital, Beijing 100730, China.
⁸ National Laboratory of Biomacromolecules, Institute of Biophysics, Chinese Academy of Sciences, Beijing 100101, China.
⁹ Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Public Health Clinical Center and Shanghai Medical College, Fudan University, Shanghai 200032, China; Lindsley F. Kimball Research Institute, New York Blood Center, New York, NY 10065, USA. Electronic address: shibojiang@fudan.edu.cn.

PMID: 26506570
DOI: 10.1016/j.micinf.2015.10.004

Abstract

Currently, there is no specific antiviral therapy for HPV infection. We conducted a randomized open-label clinical trial of JB01-BD, an anti-HPV biological dressing from Shanxi Jinbo Pharmaceutical Co., Ltd., China, for treatment of HPV infection. Seventy-seven women with cervical infection by high-risk HPV were randomly divided into a treatment group and a non-treatment group. After treatment, about 60.5% (23/38) of HPV-positive women in the treatment group became HPV-negative compared with 13.5% (5/37) of women in the non-treatment group becoming HPV-negative (P < 0.001). These data suggest that JB01-BD is an effective topical biological agent for the treatment of cervical HPV infection.

Keywords: Antiviral therapy; Cervical cancer; Clinical trial; Human papilloma virus (HPV).

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Intravaginal
Biological Dressings*
Cervix Uteri / virology
China
Female
Humans
Papillomaviridae / isolation & purification
Papillomavirus Infections / therapy*
Treatment Outcome