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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.

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    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
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    Affiliation
    Frauenklinik, Friedrich-Schiller-University of Jena, 07743 Jena, Germany. a.kaufmann@med.uni-jena.de
    Issue Date
    2002-12
    
    Metadata
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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.
    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
    Clinical Cancer Research
    URI
    http://hdl.handle.net/10541/82464
    PubMed ID
    12473576
    Type
    Article
    Language
    en
    ISSN
    1078-0432
    Collections
    All Paterson Institute for Cancer Research

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