期刊
VACCINE
卷 27, 期 30, 页码 3975-3983出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2009.04.041
关键词
Listeria monocytogenes; Cancer vaccine; Human papillomavirus; Cervical cancer
资金
- Advaxis, Inc.
Invasive carcinoma of the cervix (ICC) is the second most common cancer in women worldwide. Lm-LLO-E7 vaccine is a live-attenuated Listeria monocytogenes (Lm) that secretes the HPV-16 E7 antigen fused to a non-hemolytic fragment of the Lm protein listeriolysin O (LLO). In this Phase I trial, the safety of Lm-LLO-E7 was assessed in 15 patients with previously treated metastatic, refractory or recurrent ICC. Patients received 1 of 3 dose levels of Lm-LLO-E7 (1 x 10(9) CFU, 3.3 x 10(9) CFU or 1 x 10(10) CFU) as all intravenous infusion, followed by a second dose 3 weeks later. All patients experienced a flu-like syndrome which responded to non-prescription symptomatic treatment. Severe (grade 3) adverse events related to Lm-LLO-E7 were reported in 6 patients (40%), but no grade 4 adverse events were observed. At the highest dose some patients had severe fever and dose limiting hypotension. By the end of the study protocol, 2 patients had died, 5 had progressed, 7 had stable disease and 1 qualified as a partial responder. This study shows for the first time that a live-attenuated Lm is safe to be administered to late stage ICC patients. (C) 2009 Elsevier Ltd. All rights reserved.
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