Safety Study to Test the Safety of HspE7 and Poly-ICLC Given in Patients With Cervical Intraepithelial Neoplasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00493545|
Recruitment Status : Unknown
Verified May 2008 by Nventa Biopharmaceuticals Corporation.
Recruitment status was: Active, not recruiting
First Posted : June 28, 2007
Last Update Posted : May 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Cervical Intraepithelial Neoplasia||Biological: HspE7 and Poly-ICLC||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Nonrandomized, Open-Label Phase 1 Safety Study of HspE7 and Poly-ICLC Administered Concomitantly in Cervical Intraepithelial Neoplasia (CIN) Subjects|
|Study Start Date :||May 2007|
|Estimated Primary Completion Date :||June 2008|
|Estimated Study Completion Date :||June 2008|
Biological: HspE7 and Poly-ICLC
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00493545
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|Medical Center for Clinical Research|
|San Diego, California, United States, 92108|
|United States, Georgia|
|Medical College of Georgia|
|Augusta, Georgia, United States, 30912|
|United States, New York|
|Montefiore Medical Center|
|New York, New York, United States, 10461|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center (OUHSC) / OU Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|United States, Utah|
|Mt Timpanagos Women's Health Center|
|Pleasant Grove, Utah, United States, 84062|
|Salt Lake Women's Center|
|S. Salt Lake, Utah, United States, 84070|