376. HUMAN VAGINAL—ECTOCERVIAL TISSUE MODEL TO TEST THE IRRITATION POTENTIAL OF CONTRACEPTIVE AND VAGINAL-CARE PRODUCTS.

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Ayehunie, S., Cannon, C., Lamore, S., Klausner, M., Sheasgreen, J., MatTek Corporation, Ashland, MA, USA. Presented at 5th World Congress, Berlin, Germany, August, (2005).

Summary:
This study by scientists at MatTek Corp. demonstrated that MatTek’s EpiVaginal in vitro human cervico-vaginal tissue equivalent is a highly reproducible, non-animal assay that can be used to assess the irritation potential of vaginal care products, and that the EpiVaginal VLC in vitro tissue model can be used in studies pertaining to HIV infection, microbicides efficacy and drug absorption.

EpiVaginal™ vaginal-ectocervical (VEC) tissues were reconstructed using normal human VEC epithelial cells. Also, normal human dendritic cells were incorporated (designated as EpiVaginal VLC). Both tissues mimic native in vivo tissue in that they have basal, parabasal, glycogenated intermediate, and the superficial cell layers.

To test the utility of the tissue, contraceptives, microbicides, anti-itch agents, and other vaginal-care products (VCP) were topically applied. To mimic the heterosexual HIV infection, the tissue model was topically exposed to HIV-1 viruses.

Quality control (QC) testing on each batch of tissue utilized Triton X-100 (1%) and water as positive and negative controls, respectively. The MTT assay was used to determine the exposure time necessary to decrease the tissue viability to 50% (ET50) for the positive control and 20 vaginal care products.

QC testing showed the tissues to be highly reproducible; the average intra-lot coefficient of variation (CV) was <10% and ET-50s averaged 1.10 hr ± 0.27 (n=15 lots).

The EpiVaginal VEC tissue model discriminated between the mildness of vaginal care products. The ET50 values ranged between 1.7-2.7 hr for feminine washes, 3.5-7.0 hr for contraceptives, 6.9->18 hr for anti-itch creams, and were > 18 hr for douches, lubricants, and anti-fungal creams. Released cytokines and gene expression levels showed that IL-1á, IL-1â, and IL-8 were associated with toxicity of the vaginal care products.

In addition, the EpiVaginal VLC tissue was infectible with macrophage-tropic and T-cell tropic HIV-1 strains.

The EpiVaginal VEC tissue model will serve as a useful, highly reproducible, non-animal tool to assess the irritation of vaginal care products. The EpiVaginal VLC in vitro tissue model will also enable studies pertaining to HIV infection, microbicides and drug absorption.

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EpiVaginal Data Sheet

EpiVaginal Specifications

EpiVaginal Technical References

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Applications: Cytokine expression/analysis, Infectious disease research, Irritation - vaginal, Microbicides, Personal care products

Keywords: Anti-itch agents, Contraceptives, Cytokines, Drug absorption, EpiVaginal, Feminine Care Products, HIV infection, Heterosexual HIV infection, IL-1a, IL-1b, IL-8, Irritation, MTT, MTT assay, Microbicide, Microbicides, Normal human dendritic cells (VLC), PAS staining, Triton X-100 (1%), Vaginal care products (VCP), Vaginal-Ectocervical Tissue (VEC)

Endpoints: Cytokine release, Histology (H&E staining), MTT assay

Materials Tested: Anti-fungal Agents, Anti-itch cream, BAK, Benzocaine, Clotrimazole (2%), Douche, Douche – medicated, Feminine wash (normal), Feminine wash (sensitive), Glycerin, Miconazole nitrate (2%), Nonoxynol-9, Peronal lubricant, Povidence-iodine (3%), Povidene-iodine (0.3%), Pramoxine HCl, Resorcinol, Spermicide, Tioconazole (6.5%), Vinegar

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