Borysiewicz L K, Fiander A, Nimako M, Man S, Wilkinson G W, Westmoreland D, Evans A S, Adams M, Stacey S N, Boursnell M E, Rutherford E, Hickling J K, Inglis S C
Department of Medicine, University of Wales College of Medicine, Cardiff, UK.
Lancet. 1996 Jun 1;347(9014):1523-7. doi: 10.1016/s0140-6736(96)90674-1.
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).
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.
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.
Further studies to investigate the use ot TA-HPV for immunotherapy of cervical cancer are warranted.
人乳头瘤病毒（HPV）感染，尤其是16型或18型感染，与宫颈癌相关。两种HPV蛋白，E6和E7，在肿瘤细胞中持续表达。本研究的目的是在首个表达HPV 16和18型E6和E7蛋白的重组痘苗病毒活疫苗（TA-HPV）临床试验中，检验其临床和环境安全性以及免疫原性。
该研究是一项针对8例晚期宫颈癌患者的开放标签I/II期试验。患者接种单剂量TA-HPV，并严格隔离以监测局部和全身副作用、环境传播以及抗E6/E7免疫反应。
接种疫苗未产生明显临床副作用，且活的TA-HPV未造成环境污染。每位患者都产生了抗痘苗抗体反应，8例患者中有3例产生了可归因于接种疫苗的HPV特异性抗体反应。在3例可评估患者中的1例检测到HPV特异性细胞毒性T淋巴细胞，这是最有可能具有治疗益处的效应机制。
有必要进一步研究TA-HPV用于宫颈癌免疫治疗的用途。
