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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.
Clin Cancer Res. 2002 Dec; 8(12):3676-85.CC

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+Show Affiliations

Frauenklinik, Friedrich-Schiller-University of Jena, 07743 Jena, Germany. a.kaufmann@med.uni-jena.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12473576

Citation

Kaufmann, Andreas M., et al. "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." Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, vol. 8, no. 12, 2002, pp. 3676-85.
Kaufmann AM, Stern PL, Rankin EM, et al. 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. Clin Cancer Res. 2002;8(12):3676-85.
Kaufmann, A. M., Stern, P. L., Rankin, E. M., Sommer, H., Nuessler, V., Schneider, A., Adams, M., Onon, T. S., Bauknecht, T., Wagner, U., Kroon, K., Hickling, J., Boswell, C. M., Stacey, S. N., Kitchener, H. C., Gillard, J., Wanders, J., Roberts, J. S., & Zwierzina, H. (2002). 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. Clinical Cancer Research : an Official Journal of the American Association for Cancer Research, 8(12), 3676-85.
Kaufmann AM, et al. 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. Clin Cancer Res. 2002;8(12):3676-85. PubMed PMID: 12473576.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Kaufmann,Andreas M, AU - Stern,Peter L, AU - Rankin,Elaine M, AU - Sommer,Harald, AU - Nuessler,Volkmar, AU - Schneider,Achim, AU - Adams,Malcom, AU - Onon,Toli S, AU - Bauknecht,Thomas, AU - Wagner,Uwe, AU - Kroon,Karlijn, AU - Hickling,Julian, AU - Boswell,Christopher M, AU - Stacey,Simon N, AU - Kitchener,Henry C, AU - Gillard,Jennifer, AU - Wanders,Jantien, AU - Roberts,John St C, AU - Zwierzina,Heinz, PY - 2002/12/11/pubmed PY - 2003/1/22/medline PY - 2002/12/11/entrez SP - 3676 EP - 85 JF - Clinical cancer research : an official journal of the American Association for Cancer Research JO - Clin Cancer Res VL - 8 IS - 12 N2 - 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. SN - 1078-0432 UR - https://www.unboundmedicine.com/medline/citation/12473576/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_ L2 - http://clincancerres.aacrjournals.org/cgi/pmidlookup?view=long&pmid=12473576 DB - PRIME DP - Unbound Medicine ER -