alexa Phase II trial of imiquimod and HPV therapeutic vaccination in patients with vulval intraepithelial neoplasia.
Pharmaceutical Sciences

Pharmaceutical Sciences

Journal of Developing Drugs

Author(s): Daayana S, Elkord E, Winters U, Pawlita M, Roden R,

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Abstract BACKGROUND: Vulval intraepithelial neoplasia (VIN) is a premalignant condition, which is frequently associated with type HPV16 infection, and multifocal disease has high rates of surgical treatment failure. METHODS: We report a phase II clinical trial of the topical immunomodulator, imiquimod, for 8 weeks, followed by 3 doses (weeks 10, 14 and 18) of therapeutic human papillomavirus (HPV) vaccination (TA-CIN, fusion protein HPV16 E6E7L2) in 19 women with VIN grades 2 and 3. Histology and HPV testing of biopsies were performed at weeks 0, 10, 20 and 52. Intralesional infiltration of T-cell subsets and lymphocyte proliferation for HPV systemic immune responses were also assessed. RESULTS: Lesion response (complete regression of VIN on histology) was observed in 32\% (6 out of 19) of women at week 10, increasing to 58\% (11 out of 19) at week 20 and 63\% (12 out of 19) at week 52. At this time, 36\% (5 out of 14) of lesions showed HPV16 clearance and 79\% (15 out of 19) of women were symptom free. At week 20, after treatment with imiquimod and vaccination, there was significantly increased local infiltration of CD8 and CD4 T cells in lesion responders; in contrast, non-responders (persistent VIN by histology) showed an increased density of T regulatory cells. After vaccination, only lesion responders had significantly increased lympho-proliferation to the HPV vaccine antigens. CONCLUSION: The therapeutic effect of treatment depends on the differential immune response of responders and non-responders with affect locally and systemically.
This article was published in Br J Cancer and referenced in Journal of Developing Drugs

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