TY - JOUR T1 - Prime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - 1075 LP - 1081 DO - 10.1136/ijgc-00009577-200605000-00020 VL - 16 IS - 3 AU - A. N. Fiander AU - A. J. Tristram AU - E. J. Davidson AU - A. E. Tomlinson AU - S. Man AU - P. J. Baldwin AU - J. C. Sterling AU - H. C. Kitchener Y1 - 2006/04/01 UR - http://ijgc.bmj.com/content/16/3/1075.abstract N2 - The objective of this study was to determine the clinical effectiveness of a prime-boost human papillomavirus (HPV) vaccine regimen. A nonrandomized phase II prime-boost vaccine trial was conducted. Women with biopsy-proven anogenital intraepithelial neoplasia (AGIN) 3 were vaccinated with three doses of a recombinant fusion protein comprising HPV 16, E6/E7/L2 (TA-CIN) followed by one dose of a recombinant vaccinia virus encoding HPV 16 and 18 E6/E7 (TA-HPV). Clinical responses were evaluated by serial photographs, symptomatology, and biopsies before and after vaccination. Twenty-nine women were vaccinated; 27 with vulval intraepithelial neoplasia 3 and 2 with vaginal intraepithelial neoplasia grade 3. Clinical responses were seen in five women (17%), with one complete and five partial responses. Fifteen women (62%) had symptomatic improvement. No serious adverse effects were recorded. This is the first trial of a prime-boost vaccination regimen using heterologous HPV vaccines (TA-CIN followed by TA-HPV) in the management of AGIN. Since the prime-boost approach in this cohort offered no significant advantages over single TA-HPV vaccination, there are no further studies planned using this protocol. Future studies are warranted to define responders to immunotherapy. ER -