321.

CONCORDANCE BETWEEN DIFFERENT IN VITRO CULTURE MODELS DESIGNED TO PREDICT VAGINAL IRRITATION AND/OR TOXICITY. Watts, P., Nuttall¹, J., Coplan¹, P., Fairhurst¹, D., Mitchnick¹, M., and Shattock, R. St. George’s Hospital Medical School, London, UK, and ¹International Partnership for Microbicides (IPM), Silver Spring, MD, USA. Presented at Microbicides 2004, London, England, March 28-31, (2004).

Keywords: Chemotactic cytokines, Cytokine, Cytokine analysis, Cytokine production, D5, EPI-200, Eotaxin, EpiVaginal, GM-CSF, HIV-1, IL-1, IL-6, IL-8, KY Jelly, MCP-1, MIP-1a, MIP-1b, MTT, MTT ET-50 tissue viability assay, MTT assay, Microbicides, Mucosal culture models, Nonoxynol-9, RANTES, SLS, Silicones 300CP, TNF-a, Tissue/cell viability, VEC-100, Vaginal epithelial cells, Vaginal irritation, Vaginal safety, Vaginal toxicity

Endpoints: Cytokine analysis, MTT dye reduction

Materials Tested: 300 CP, D5, KY Jelly, Nonoxynol-9, SLS

Summary:
The safety profile of potential microbicides is equally, if not more important than anti-HIV activity. At the very least, candidates must not impair natural defences against HIV-1 infection or cause inflammation.

In this study, researchers at St. George’s Hospital Medical School (UK) and the International Partnership for Microbicides (IPM) investigated the concordance between five different in vitro culture models used to predict vaginal toxicity and/or irritation.

To this end the researchers selected 2 potential constituents of microbicide products (silicones 300 CP and D5), 2 with known toxic properties (SLS & N9), and a common vaginal formulation (KY jelly) to assess their effects on tissue/cell viability and cytokine production in the different models.

Presented data show good correlation between different models and suggest assessment of tissue viability and/or cytokine production may be predictive of vaginal safety.

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