Safety evaluation of chemically modified beta-lactoglobulin administered intravaginally

J Med Virol. 2016 Jun;88(6):1098-101. doi: 10.1002/jmv.24439. Epub 2016 Jan 5.

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.

Keywords: antiviral therapy; clinical trial; human papilloma virus (HPV); safety evaluation.

Publication types

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

MeSH terms

  • Administration, Intravaginal
  • Adult
  • Aged
  • Animals
  • Antiviral Agents / administration & dosage*
  • Antiviral Agents / adverse effects*
  • Cattle
  • Female
  • Humans
  • Lactoglobulins / administration & dosage*
  • Lactoglobulins / adverse effects*
  • Lactoglobulins / chemistry
  • Middle Aged
  • Papillomaviridae / drug effects
  • Papillomavirus Infections / drug therapy*
  • Phthalic Anhydrides

Substances

  • Antiviral Agents
  • Lactoglobulins
  • Phthalic Anhydrides
  • 3-hydroxyphthalic anhydride