A recombinant vaccinia virus encoding human papillomavirus types 16 and 18, E6 and E7 proteins as immunotherapy for cervical cancer

Lancet. 1996 Jun 1;347(9014):1523-7. doi: 10.1016/s0140-6736(96)90674-1.


Background: Human papillomavirus (HPV) infection, especially with type 16 or 18, is associated with cervical cancer. Two HPV proteins, E6 and E7, are consistently expressed in tumour cells. The objectives of the study were to examine the clinical and environmental safety and immunogenicity in the first clinical trial of a live recombinant vaccinia virus expressing the E6 and E7 proteins of HPV 16 and 18 (TA-HPV).

Methods: The study was an open label phase I/II trial in eight patients with late stage cervical cancer. The patients were vaccinated with a single dose of TA-HPV and kept in strict isolation to monitor local and systemic side-effects, environmental spread, and anti-E6/E7 immune responses.

Findings: Vaccination resulted in no significant clinical side-effects and there was no environmental contamination by live TA-HPV. Each patient mounted an antivaccinia antibody response and three of the eight patients developed an HPV-specific antibody response that could be ascribed to the vaccination. HPV-specific cytotoxic T lymphocytes, the effector mechanism most likely to be of therapeutic benefit, were detected in one of three evaluable patients.

Interpretation: Further studies to investigate the use ot TA-HPV for immunotherapy of cervical cancer are warranted.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Viral / immunology
  • DNA-Binding Proteins*
  • Female
  • Humans
  • Immunotherapy, Active*
  • Middle Aged
  • Oncogene Proteins, Viral* / therapeutic use*
  • Papillomaviridae*
  • Papillomavirus E7 Proteins
  • Papillomavirus Vaccines
  • Repressor Proteins*
  • T-Lymphocytes, Cytotoxic / immunology
  • Uterine Cervical Neoplasms / immunology
  • Uterine Cervical Neoplasms / therapy*
  • Uterine Cervical Neoplasms / virology
  • Vaccines, Synthetic / therapeutic use*
  • Vaccinia virus*
  • Viral Vaccines


  • Antibodies, Viral
  • DNA-Binding Proteins
  • E6 protein, Human papillomavirus type 16
  • E6 protein, Human papillomavirus type 18
  • E7 protein, Human papillomavirus type 18
  • Oncogene Proteins, Viral
  • Papillomavirus E7 Proteins
  • Papillomavirus Vaccines
  • Repressor Proteins
  • Vaccines, Synthetic
  • Viral Vaccines
  • human papillomavirus vaccine, TA
  • oncogene protein E7, Human papillomavirus type 16