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Safety and immunogenicity of TA-HPV, a recombinant vaccinia virus expressing modified human papillomavirus (HPV)-16 and HPV-18 E6 and E7 genes, in women with progressive cervical cancer.

Kaufmann, Andreas M
; 
Stern, Peter L
; 
Rankin, Elaine M
; 
Sommer, Harald
; 
Nuessler, Volkmar
; 
Schneider, Achim
; 
Adams, Malcolm
; 
Onon, Toli S
; 
Bauknecht, Thomas
; 
Wagner, Uwe
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Abstract
PURPOSE: Cervical cancer, the second most common malignancy in women worldwide, is almost invariably associated with infection by human papillomavirus (HPV). HPV-16 or -18 is commonly present in 70% of cervical cancers. HPV-positive tumor cells present antigens of the viral protein in the context of human leukocyte antigen (HLA) class I that can be recognized by CTLs. We have conducted a study in patients with early-stage cervical cancer to assess the safety and immunological effects of vaccination with TA-HPV, a live recombinant vaccinia virus expressing modified forms of the HPV-16 and -18 E6 and E7 proteins. EXPERIMENTAL DESIGN: Twenty-nine patients with clinical International Federation of Gynecologists and Obstetricians (FIGO) stage Ib or IIa cervical cancer were given two vaccinations with TA-HPV at least 4 weeks apart, starting 2 weeks before radical hysterectomy. Patients were monitored closely for side effects of the vaccination. Serial blood samples were examined for HPV-specific CTLs or changes in levels of antibodies to HPV-16 or -18 E6 and E7 proteins and to vaccinia virus. RESULTS: Vaccination with recombinant vaccinia was well tolerated in all patients with only mild to moderate local toxicity, and no serious adverse events were attributable to the vaccine. After a single vaccination, HPV-specific CTLs were found in four patients (HLA A1, A3, three patients; HLA A1, A24, one patient). Eight patients developed HPV-specific serological responses. CONCLUSIONS: This study confirmed the safety and immunogenicity of the vaccine in a proportion of those patients vaccinated. Additional clinical studies using TA-HPV in combination with an additional experimental vaccine for HPV-16 are currently under way.
Authors
Kaufmann, Andreas M
Stern, Peter L
Rankin, Elaine M
Sommer, Harald
Nuessler, Volkmar
Schneider, Achim
Adams, Malcolm
Onon, Toli S
Bauknecht, Thomas
Wagner, Uwe
Kroon, Karlijn
Hickling, Julian K
Boswell, Christopher M
Stacey, Simon N
Kitchener, Henry C
Gillard, Jennifer
Wanders, Jantien
Roberts, John St C
Zwierzina, Heinz
Affiliation
Frauenklinik, Friedrich-Schiller-University of Jena, 07743 Jena, Germany. a.kaufmann@med.uni-jena.de
Description
Date
2002-12
Publisher
Collections
All Paterson Institute for Cancer Research
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Keywords
Cancer Staging
Tumour Virus Infections
Uterine Cervical Cancer
Type
Article
Citation
Safety and immunogenicity of TA-HPV, a recombinant vaccinia virus expressing modified human papillomavirus (HPV)-16 and HPV-18 E6 and E7 genes, in women with progressive cervical cancer. 2002, 8 (12):3676-85 Clin. Cancer Res.
Journal Title
Journal ISSN
Volume Title
URI
http://hdl.handle.net/10541/82464
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