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

2.50
Hdl Handle:
http://hdl.handle.net/10541/72691
Title:
Prime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial.
Authors:
Fiander, Alison N; Tristram, Amanda; Davidson, Emma J; Tomlinson, Anne E; Man, Stephen; Baldwin, Peter J W; Sterling, Jane C; Kitchener, Henry C
Abstract:
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.
Affiliation:
Academic Department of Obstetrics and Gynaecology, Wales College of Medicine, Cardiff University, Heath Park, Cardiff, UK. fianderan@cf.ac.uk
Citation:
Prime-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
Journal:
International Journal of Gynecological Cancer
Issue Date:
7-Jul-2009
URI:
http://hdl.handle.net/10541/72691
DOI:
10.1111/j.1525-1438.2006.00598.x
PubMed ID:
16803488
Type:
Article
Language:
en
ISSN:
1048-891X
Appears in Collections:
All Paterson Institute for Cancer Research

Full metadata record

DC FieldValue Language
dc.contributor.authorFiander, Alison N-
dc.contributor.authorTristram, Amanda-
dc.contributor.authorDavidson, Emma J-
dc.contributor.authorTomlinson, Anne E-
dc.contributor.authorMan, Stephen-
dc.contributor.authorBaldwin, Peter J W-
dc.contributor.authorSterling, Jane C-
dc.contributor.authorKitchener, Henry C-
dc.date.accessioned2009-07-07T11:02:46Z-
dc.date.available2009-07-07T11:02:46Z-
dc.date.issued2009-07-07T11:02:46Z-
dc.identifier.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. Canceren
dc.identifier.issn1048-891X-
dc.identifier.pmid16803488-
dc.identifier.doi10.1111/j.1525-1438.2006.00598.x-
dc.identifier.urihttp://hdl.handle.net/10541/72691-
dc.description.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.en
dc.language.isoenen
dc.subjectAnus Canceren
dc.subjectFemale Genital Canceren
dc.subject.meshAdult-
dc.subject.meshAnus Neoplasms-
dc.subject.meshCarcinoma in Situ-
dc.subject.meshFemale-
dc.subject.meshGenital Neoplasms, Female-
dc.subject.meshHuman papillomavirus 16-
dc.subject.meshHumans-
dc.subject.meshImmunization Schedule-
dc.subject.meshImmunization, Secondary-
dc.subject.meshMiddle Aged-
dc.subject.meshPapillomavirus Vaccines-
dc.subject.meshVaccines, Synthetic-
dc.subject.meshVaccinia virus-
dc.titlePrime-boost vaccination strategy in women with high-grade, noncervical anogenital intraepithelial neoplasia: clinical results from a multicenter phase II trial.en
dc.typeArticleen
dc.contributor.departmentAcademic Department of Obstetrics and Gynaecology, Wales College of Medicine, Cardiff University, Heath Park, Cardiff, UK. fianderan@cf.ac.uken
dc.identifier.journalInternational Journal of Gynecological Canceren

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