drugset / Trial / NCT01116245

An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+

NCT01116245

Phase 2 Terminated 81 enrolled Advaxis, Inc.
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2010-04
Primary completion
2013-12
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ADXS11-001 Vaccine 5e+07 unknown Intravenous
Subject ADXS11-001 Vaccine 3.3e+08 unknown Intravenous
Subject ADXS11-001 Vaccine 1e+09 unknown Intravenous