The first clinical use of a live-attenuated Listeria monocytogenes vaccine: a Phase I safety study of Lm-LLO-E7 in patients with advanced carcinoma of the cervix.

摘要: Abstract Invasive carcinoma of the cervix (ICC) is second most common cancer in women worldwide. Lm -LLO-E7 vaccine a live-attenuated Listeria monocytogenes ( ) that secretes HPV-16 E7 antigen fused to non-hemolytic fragment protein listeriolysin O (LLO). In this Phase I trial, safety was assessed 15 patients with previously treated metastatic, refractory or recurrent ICC. Patients received 1 3 dose levels (1 × 10 9  CFU, 3.3 × 10  CFU 1 × 10 10  CFU) as an intravenous infusion, followed by weeks later. All experienced flu-like syndrome which responded non-prescription symptomatic treatment. Severe (grade 3) adverse events related were reported 6 (40%), but no grade 4 observed. At highest some had severe fever and limiting hypotension. By end study protocol, 2 died, 5 progressed, 7 stable disease qualified partial responder. This shows for first time safe be administered late stage ICC patients.