A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Safety of HspE7 and Poly-ICLC administered concomitantly for Cervical Intraepithelial Neoplasia
4 Weeks after the last of 3 Injections
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Montefiore Medical Center||Bronx, New York 10467-2490|
|Medical College of Georgia||Augusta, Georgia 30912|
|University of Southern California||Los Angeles, California 90033|
|Medical Center for Clinical Research||San Diego, California 92108|
|University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center||Oklahoma City, Oklahoma 73104|
|Mt Timpanagos Women's Health Center||Pleasant Grove, Utah 84062|
|Salt Lake Women's Center||S. Salt Lake, Utah 84070|