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    Keywords: CANCER ; CELLS ; proliferation ; CELL ; DISEASE ; PROTEIN ; INFECTION ; ANTIGEN ; T-CELL ; T-CELLS ; papillomavirus ; IMMUNE-RESPONSES ; TRIAL ; LESIONS ; NEOPLASIA ; OVARIAN-CANCER ; WOMEN ; CERVICAL-CANCER ; human papillomavirus ; HPV ; IMMUNE-RESPONSE ; HUMAN-PAPILLOMAVIRUS TYPE-16 ; FAILURE ; ANTITUMOR IMMUNITY ; SUBSETS ; FUSION PROTEIN ; PHASE-II ; ONCOLOGY ; REGRESSION ; REGULATORY T-CELLS ; PHASE ; PHOTODYNAMIC THERAPY ; imiquimod ; CD4+T-CELL IMMUNITY ; IMMUNE ; T regulatory cells ; CLINICAL-RESPONSES ; SEXUAL FUNCTION ; therapeutic HPV vaccination ; vulval intraepithelial neoplasia (VIN)
    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. British Journal of Cancer (2010) 102, 1129-1136. doi:10.1038/sj.bjc.6605611 www.bjcancer.com Published online 16 March 2010 (C) 2010 Cancer Research UK
    Type of Publication: Journal article published
    PubMed ID: 20234368
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