PMID- 12473576
OWN - NLM
STAT- MEDLINE
DCOM- 20030121
LR  - 20221207
IS  - 1078-0432 (Print)
IS  - 1078-0432 (Linking)
VI  - 8
IP  - 12
DP  - 2002 Dec
TI  - 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.
PG  - 3676-85
AB  - 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.
FAU - Kaufmann, Andreas M
AU  - Kaufmann AM
AD  - Frauenklinik, Friedrich-Schiller-University of Jena, 07743 Jena, Germany. 
      a.kaufmann@med.uni-jena.de
FAU - Stern, Peter L
AU  - Stern PL
FAU - Rankin, Elaine M
AU  - Rankin EM
FAU - Sommer, Harald
AU  - Sommer H
FAU - Nuessler, Volkmar
AU  - Nuessler V
FAU - Schneider, Achim
AU  - Schneider A
FAU - Adams, Malcom
AU  - Adams M
FAU - Onon, Toli S
AU  - Onon TS
FAU - Bauknecht, Thomas
AU  - Bauknecht T
FAU - Wagner, Uwe
AU  - Wagner U
FAU - Kroon, Karlijn
AU  - Kroon K
FAU - Hickling, Julian
AU  - Hickling J
FAU - Boswell, Christopher M
AU  - Boswell CM
FAU - Stacey, Simon N
AU  - Stacey SN
FAU - Kitchener, Henry C
AU  - Kitchener HC
FAU - Gillard, Jennifer
AU  - Gillard J
FAU - Wanders, Jantien
AU  - Wanders J
FAU - Roberts, John St C
AU  - Roberts JS
FAU - Zwierzina, Heinz
AU  - Zwierzina H
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - 0 (Antibodies, Viral)
RN  - 0 (DNA, Viral)
RN  - 0 (DNA-Binding Proteins)
RN  - 0 (E6 protein, Human papillomavirus type 16)
RN  - 0 (E6 protein, Human papillomavirus type 18)
RN  - 0 (E7 protein, Human papillomavirus type 18)
RN  - 0 (HLA-A1 Antigen)
RN  - 0 (Oncogene Proteins, Viral)
RN  - 0 (Papillomavirus E7 Proteins)
RN  - 0 (Papillomavirus Vaccines)
RN  - 0 (Repressor Proteins)
RN  - 0 (Vaccines, Synthetic)
RN  - 0 (Viral Vaccines)
RN  - 0 (human papillomavirus vaccine, TA)
RN  - 0 (oncogene protein E7, Human papillomavirus type 16)
SB  - IM
MH  - Adenocarcinoma/prevention & control/virology
MH  - Adult
MH  - Aged
MH  - Antibodies, Viral/immunology
MH  - Carcinoma, Squamous Cell/prevention & control/virology
MH  - DNA, Viral/metabolism
MH  - *DNA-Binding Proteins
MH  - Female
MH  - Genotype
MH  - HLA-A1 Antigen/metabolism
MH  - Humans
MH  - Immunoenzyme Techniques
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Oncogene Proteins, Viral/*genetics/*therapeutic use
MH  - Papillomaviridae/*immunology
MH  - Papillomavirus E7 Proteins
MH  - Papillomavirus Infections/*prevention & control/virology
MH  - Papillomavirus Vaccines
MH  - Phenotype
MH  - Polymerase Chain Reaction
MH  - Polymorphism, Single-Stranded Conformational
MH  - *Repressor Proteins
MH  - Seroepidemiologic Studies
MH  - T-Lymphocytes, Cytotoxic/immunology
MH  - Tumor Virus Infections/*prevention & control/virology
MH  - Uterine Cervical Neoplasms/*prevention & control/virology
MH  - Vaccination
MH  - Vaccines, Synthetic
MH  - Vaccinia virus/genetics
MH  - Viral Vaccines/therapeutic use
MH  - Uterine Cervical Dysplasia/prevention & control/virology
EDAT- 2002/12/11 04:00
MHDA- 2003/01/22 04:00
CRDT- 2002/12/11 04:00
PHST- 2002/12/11 04:00 [pubmed]
PHST- 2003/01/22 04:00 [medline]
PHST- 2002/12/11 04:00 [entrez]
PST - ppublish
SO  - Clin Cancer Res. 2002 Dec;8(12):3676-85.