Pre-clinical safety and efficacy of TA-CIN, a recombinant HPV16 L2E6E7 fusion protein vaccine, in homologous and heterologous prime-boost regimens

Human papillomavirus (HPV) E6 and E7 oncoproteins are attractive targets fo r T-cell;based immunotherapy of cervical intraepithelial neoplasia (CIN) an d cancer. A newly designed vaccine, comprising the HPV16 L2, E6 and E7 as a single fusion protein (TA-CIN), was shown to elicit HPV16-specific CTL, T- helper cells and antibodies in a pre-clinical mouse model. These immune res ponses effectively prevented outgrowth of HPV16-positive tumour cells in a prophylactic setting as well as in a minimal residual disease setting. CTL immunity was optimally induced when TA-CIN was employed in heterologous pri me-boost regimens in combination with TA-HPV. a clinical grade vaccinia-bas ed vaccine. These data provide a scientific basis for the use of TA-CIN, al one or in combination with TA-HPV in future human trials. (C) 2001 Elsevier Science Ltd. All rights reserved.