An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Cervical Intraepithelial Neoplasia
In brief
Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.
Key facts
- Study ID
- NCT01116245
- Run by
- Advaxis, Inc.
- People needed
- 81
- Starts
- 2010-04-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-07-27
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed CIN 2/3 that requires surgical intervention
You may not qualify if…
- Previous history of listeriosis
- Steroid use
- Antibiotic use
- Negative anergy panel
- HIV positive
- Pregnant or actively trying during the treatment period
- Intercurrent disease
Where it is running
- New Horizons Women's Care, LLC — Chandler, Arizona, United States
- Arizona OB/GYN Affiliates, PC — Phoenix, Arizona, United States
- Precision Trials — Phoenix, Arizona, United States
- Visions Clinical Research - Tucson — Tucson, Arizona, United States
- Grossmont Center for Clinical Research — La Mesa, California, United States
- Visions Clinical Research — Boynton Beach, Florida, United States
- Altus Research — Lake Worth, Florida, United States
- Center for Women — Chicago, Illinois, United States
- Indiana University Dept. of OB/GYN Oncology — Indianapolis, Indiana, United States
- New York Downtown Hospital — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Temple University — Philadelphia, Pennsylvania, United States
- InVisions Consultants, LLC- c/o Institute for Women's Health — San Antonio, Texas, United States
- InVisions Consultants, LLC — San Antonio, Texas, United States
- Wasatch Clinical Research — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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