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 -