375. VAGINAL FORMULATION - HOW INNOCUOUS ARE THEY TO THE VAGINAL EPITHELIAL IMMUNE FUNCTION?

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Trifonova, R.T., Pasicznyk, J.M., Fichorova, R.N. Harvard Medical School, Department of Obstetrics and Gynecology, Boston, M.A, USA. Presented at 25th Anniversary Meeting of the American Society of Reproductive Immunology, Providence, RI, June 16-18, 2005. American Journal of Reproductive Immunology, 54, (2), 121, (2005).

Summary:
This study by researchers in the Harvard Medical School Dept. of Obstetrics and Gynecology demonstrated that MatTek’s EpiVaginal in vitro human cervico-vaginal tissue equivalent is an excellent tissue model for performing both immunoinflammatory characterization and safety assessment of vaginal products.

Problem: The disruption of the epithelial barrier and activation of inflammatory pathways may lead to increased susceptibility to viral infection. Over-the-counter (OTC) vaginal products have received little attention in this regard, however the recent development of anti-HIV-1 microbicides has brought the importance of mucosal integrity to forefront. While vaginal microbicides represent a promising strategy for preventing HIV-1 and other sexually transmitted infections, they can be efficacious only if they cause no epithelial toxicity or inflammation.

Method: Researchers in the Dept. of Obstetrics and Gynecology, Harvard Medical School, used EpiVaginal, a novel organotypic cervicovaginal model (VEC100, MatTek) to compare hygienic or spermicidal OTC to the anti-HIV-1 microbicide cellulose acetate 1,2-benzenedicarboxylate (CAP).

Results: CAP film and gel formulations appeared non-toxic in MTT and LDH viability assays and did not induce release of pro-inflammatory mediators e.g. IL-1, IL-6 and IL-8 as compared to controls. In contrast, a commercially available vaginal cleansing film containing Nonoxynol-9 showed proinflammatory potential commeasurable to that of TNF.

Conclusions: This study demonstrates the usefulness of the EpiVaginal (VEC) tissue model for immunoinflammatory characterization and safety assessment of vaginal products. It provides evidence that CAP in film and gel forms may be used as a safe anti-HIV-1 prevention agent or vehicle for other vaginal products. (This study was supported by NICHD 1P01HD041761.)

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EpiVaginal Data Sheet

EpiVaginal Specifications

EpiVaginal Technical References

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Applications: Infectious disease research, Inflammation - vaginal, Irritation - vaginal, Microbicides, Personal care products

Keywords: EpiVaginal, IL-1, IL-6, IL-8, Inflammation, Inflammatory, Inflammatory mediators, LDH viability assays, MTT, Microbicide, Microbicides, Nonoxynol-9, Over-the-Counter (OTC) vaginal products, Spermicide, TNF, VEC-100, MatTek, Vaginal microbicides, Vaginal mucosa

Endpoints: LDH viabilty assay, MTT tissue viability assay

Materials Tested: Organotypic cervicovaginal tissue, Vaginal formulation

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