부산대학교 도서관

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.vaccine.2009.04.041 Byline: Paulo Cesar Maciag (a), SiniA a Radulovic (b), John Rothman (a) Keywords: Listeria monocytogenes; Cancer vaccine; Human papillomavirus; Cervical cancer Abstract: 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 (1x10.sup.9 CFU, 3.3x10.sup.9 CFU or 1x10.sup.10 CFU) as an 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. Author Affiliation: (a) Advaxis Inc. 675 US 1 North, North Brunswick, NJ 08902, USA (b) National Cancer Research Center, Pasterova 14, 11 000 Belgrade, Serbia Article History: Received 26 February 2009; Revised 6 April 2009; Accepted 13 April 2009