The purpose of this study is to determine the safety and tolerability of HspE7 and Poly-ICLC when given together
Approximately 600 million people worldwide are infected with the Human Papilloma Virus. In the majority of cases people can clear the virus on their own however in cases where the infection is not recognized or is left untreated, the result can be cervical cancer. This study will examine the safety and tolerability of Hsp-E7 and Poly-ICLC administered together as a vaccine for Cervical Intraepithelial neoplasia (CIN). There will be 4 cohorts of subjects in the study each given a higher dose than the one prior providing that prior dose has been well tolerated and deemed to be safe. Subjects will be immunized every 28 days for a period of 8 weeks (3 administrations). Posttreatment evaluation will occur 4 weeks after the last of 3 injections. Subjects with CIN 2 or 3 disease at the time of enrollment will be eligible to undergo clinically appropriate therapeutic treatment of the cervix at the twelfth of the study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
24
3 injections of HspE7 and Poly ICLC given every 28 days for 3 injections
University of Southern California
Los Angeles, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Medical College of Georgia
Augusta, Georgia, United States
Montefiore Medical Center
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Time frame: 4 Weeks after the last of 3 Injections
Tolerability of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
Time frame: 4 Weeks after the last of 3 Injections
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New York, New York, United States
University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center
Oklahoma City, Oklahoma, United States
Baylor College of Medicine
Houston, Texas, United States
Mt Timpanagos Women's Health Center
Pleasant Grove, Utah, United States
Salt Lake Women's Center
South Salt Lake, Utah, United States