Prime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial.
AuthorsFiander, Alison N
Davidson, Emma J
Tomlinson, Anne E
Baldwin, Peter J W
Sterling, Jane C
Kitchener, Henry C
AffiliationAcademic Department of Obstetrics and Gynaecology, Wales College of Medicine, Cardiff University, Heath Park, Cardiff, UK. firstname.lastname@example.org
MetadataShow full item record
AbstractThe 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.
CitationPrime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial., 16 (3):1075-81 Int. J. Gynecol. Cancer
JournalInternational Journal of Gynecological Cancer
- Immunological responses in women with human papillomavirus type 16 (HPV-16)-associated anogenital intraepithelial neoplasia induced by heterologous prime-boost HPV-16 oncogene vaccination.
- Authors: Smyth LJ, Van Poelgeest MI, Davidson EJ, Kwappenberg KM, Burt D, Sehr P, Pawlita M, Man S, Hickling JK, Fiander AN, Tristram A, Kitchener HC, Offringa R, Stern PL, Van Der Burg SH
- Issue date: 2004 May 1
- TA-CIN, a vaccine incorporating a recombinant HPV fusion protein (HPV16 L2E6E7) for the potential treatment of HPV16-associated genital diseases.
- Authors: Hibbitts S
- Issue date: 2010 Oct
- Vaccinia-expressed human papillomavirus 16 and 18 e6 and e7 as a therapeutic vaccination for vulval and vaginal intraepithelial neoplasia.
- Authors: Baldwin PJ, van der Burg SH, Boswell CM, Offringa R, Hickling JK, Dobson J, Roberts JS, Latimer JA, Moseley RP, Coleman N, Stanley MA, Sterling JC
- Issue date: 2003 Nov 1
- Effect of TA-CIN (HPV 16 L2E6E7) booster immunisation in vulval intraepithelial neoplasia patients previously vaccinated with TA-HPV (vaccinia virus encoding HPV 16/18 E6E7).
- Authors: Davidson EJ, Faulkner RL, Sehr P, Pawlita M, Smyth LJ, Burt DJ, Tomlinson AE, Hickling J, Kitchener HC, Stern PL
- Issue date: 2004 Jul 29
- Immunological and clinical responses in women with vulval intraepithelial neoplasia vaccinated with a vaccinia virus encoding human papillomavirus 16/18 oncoproteins.
- Authors: Davidson EJ, Boswell CM, Sehr P, Pawlita M, Tomlinson AE, McVey RJ, Dobson J, Roberts JS, Hickling J, Kitchener HC, Stern PL
- Issue date: 2003 Sep 15