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Prime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial

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Abstract. 

Fiander AN, Tristram AJ, Davidson EJ, Tomlinson AE, Man S, Baldwin PJ, Sterling JC, Kitchener HC. Prime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial. Int J Gynecol Cancer 2006;16:1075–1081.

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.
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Keywords: anogenital neoplasia; human papillomavirus; intraepithelial neoplasia; therapeutic vaccines; vulval intraepithelial neoplasia

Document Type: Research Article

Affiliations: 1: Academic Department of Obstetrics and Gynaecology, Wales College of Medicine, Cardiff University, Cardiff, United Kingdom 2: Colposcopy Unit, St Mary’s Hospital NHS Trust, Manchester, United Kingdom 3: Section of Immunology, Department of Pathology, Wales College of Medicine, Cardiff University, Cardiff, United Kingdom 4: Gynaecological Oncology 5: Dermatology, Addenbrooke’s NHS Trust, Cambridge, United Kingdom 6: Academic Unit of Obstetrics and Gynaecology, University of Manchester, Manchester, United Kingdom

Publication date: May 1, 2006

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