Journal article
Comparative Safety Evaluation of the Candidate Vaginal Microbicide C31G
Antimicrobial agents and chemotherapy, v 49(4), pp 1509-1520
Apr 2005
PMID: 15793133
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
C31G is currently the focus of clinical trials designed to evaluate this agent as a microbicidal and spermicidal agent. In the following studies, the in vivo safety of C31G was assessed with a Swiss Webster mouse model of cervicovaginal toxicity and correlated with results from in vitro cytotoxicity experiments and published clinical observations. A single exposure of unformulated 1% C31G resulted in mild-to-moderate epithelial disruption and inflammation at 2 and 4 h postapplication. The columnar epithelium of the cervix was the primary site of damage, while no perturbation of the vaginal mucosa was observed. In contrast, application of unformulated 1.7% C31G resulted in greater levels of inflammation in the cervical epithelium at 2 h postapplication and severe epithelial disruption that persisted to 8 h postapplication. Application of a nonionic aqueous gel formulation containing 1% C31G resulted in no apparent cervicovaginal toxicity at any time point evaluated. However, formulation of 1.7% C31G did not substantially reduce the toxicity associated with unformulated C31G at that concentration. These observations correlate with findings gathered during a recent clinical trial, in which once-daily applications resulted in no adverse events in women receiving the formulation containing 1% C31G, compared to moderate-to-severe adverse events in 30% of women receiving the 1.7% C31G formulation. The Swiss Webster mouse model was able to effectively discriminate between concentrations and formulations of C31G that produced distinct clinical effects in human trials. The Swiss Webster animal model may be a highly valuable tool for preclinical evaluation of candidate vaginal microbicides.
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Details
- Title
- Comparative Safety Evaluation of the Candidate Vaginal Microbicide C31G
- Creators
- Bradley J Catalone - Departments of Microbiology and ImmunologyTina M Kish-Catalone - Departments of Microbiology and ImmunologyElizabeth B Neely - Departments of Microbiology and ImmunologyLynn R Budgeon - Departments of Microbiology and ImmunologyMary L Ferguson - Departments of Microbiology and ImmunologyCatherine Stiller - Departments of Microbiology and ImmunologyShendra R Miller - Departments of Microbiology and ImmunologyDaniel Malamud - Departments of Microbiology and ImmunologyFred C Krebs - Departments of Microbiology and ImmunologyMary K Howett - Departments of Microbiology and ImmunologyBrian Wigdahl - Departments of Microbiology and Immunology
- Publication Details
- Antimicrobial agents and chemotherapy, v 49(4), pp 1509-1520
- Publisher
- American Society for Microbiology
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Microbiology and Immunology
- Web of Science ID
- WOS:000228082500037
- Scopus ID
- 2-s2.0-20144388837
- Other Identifier
- 991014878318004721
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- Collaboration types
- Domestic collaboration
- Web of Science research areas
- Microbiology
- Pharmacology & Pharmacy