Vaccination with HPV16 peptides of patients with advanced cervical carcinoma: Clinical evaluation of a phase I-II trial

A phase I-II clinical trial was performed involving vaccination with HPV16 E7 peptides of patients suffering from HPV16 positive cervical carcinoma wh ich was refractory to conventional treatment. Patients receiving the vaccin e were HLA-A(star)0201 positive with HPV16 positive cervical carcinoma. The clinical trial was designed as a dose-escalation study, in which successiv e groups of patients received 100 mu g, 300 mu g or 1000 mu g of each pepti de, respectively. The vaccine consisted of two HPV16 E7 peptides and one he lper peptide emulsified in Montanide ISA 51 adjuvant. 19 patients were incl uded in the study, no adverse side-effects were observed. 2 patients showed stable disease for 1 year after vaccination; 15 patients showed progressiv e disease of whom 1 died during the vaccination treatment due to progressiv e disease; and 2 patients showed tumour-regression after chemotherapy follo wing vaccination. A relative low count of lymphocytes before and after vacc ination was present in 11/19 patients indicating that these patients were i mmunocompromised. This study shows that HPV16 E7 peptide vaccination is fea sible, even in a group of patients with terminal disease. This paves the wa y for vaccinating patients with less advanced disease, whose immune system is less compromised by progressive disease. (C) 1999 Elsevier Science Ltd. All rights reserved.