title: Safety evaluation of chemically modified beta-lactoglobulin administered intravaginally.
abstract: Currently, there is no specific antiviral therapy for treatment of HPV infection. Jiang and colleagues previously reported that anhydride-modified proteins have inhibitory activities against multiple viruses including HPV. Here, we evaluated the safety of 3-hydroxyphthalic anhydride-modified bovine beta-lactoglobulin, designated JB01, vaginally applied in women infected by high-risk HPV. After the vaginal application of JB01 in 38 women for 3 months, no serious adverse events were reported, and normalization of the vaginal micro-environment has been observed. It can be concluded that JB01-BD is safe for vaginal use in HPV-infected women, suggesting its potential application for the treatment of HPV infection.
authors.affiliation: First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
authors.forename: Xuetao
authors.initials: X
authors.lastname: Guo
authors.affiliation: Shanxi Medical University, Shanxi, China.
authors.forename: Lixia
authors.initials: L
authors.lastname: Qiu
authors.affiliation: Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.
authors.forename: Yonghong
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Chinese PLA General Hospital, Beijing, China.
authors.forename: Yuanguang
authors.initials: Y
authors.lastname: Meng
authors.affiliation: National Laboratory of Biomacromolecules, Institute of Biophysics, Chinese Academy of Sciences, Beijing, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Zhu
authors.affiliation: Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Public Health Clinical Center and Shanghai Medical College, Fudan University, Shanghai, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Lu
authors.affiliation: Key Laboratory of Medical Molecular Virology of Ministries of Education and Health, Shanghai Public Health Clinical Center and Shanghai Medical College, Fudan University, Shanghai, China.|Lindsley F. Kimball Research Institute, New York Blood Center, New York, New York.|Shanghai Institute of Planned Parenthood Research, Shanghai, China.
authors.forename: Shibo
authors.initials: S
authors.lastname: Jiang
mesh_terms: D000282:Administration, Intravaginal; D000328:Adult; D000368:Aged; D000818:Animals; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002417:Cattle; D005260:Female; D006801:Humans; D007782:Lactoglobulins / Q000008:administration & dosage* / Q000009:adverse effects* / Q000737:chemistry; D008875:Middle Aged; D027383:Papillomaviridae / Q000187:drug effects; D030361:Papillomavirus Infections / Q000188:drug therapy*; D010796:Phthalic Anhydrides
chemical_list: D000998:Antiviral Agents; D007782:Lactoglobulins; D010796:Phthalic Anhydrides; C478070:3-hydroxyphthalic anhydride
keywords: antiviral therapy; clinical trial; human papilloma virus (HPV); safety evaluation