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NCT01116245 · ClinicalTrials.gov registry record · Phase 2
An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+
A Phase 2 study, sponsored by Advaxis.
- Terminated
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
NCT01116245: Clinical Trial Phase 2 study, sponsored by Advaxis.
NCT01116245 is a Phase 2 study that was terminated before completion, run by Advaxis. The registered enrollment target is 81 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116245, a Phase 2 study, was terminated before completion, sponsored by Advaxis.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo Control
- BIOLOGICAL ADXS11-001 (Lm-LLO-E7)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2010-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
Why NCT01116245 stopped before completion
NCT01116245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Control is the first listed.
NCT01116245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116245 about?
NCT01116245 is a clinical study titled "An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+". 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 can...
What is the current status of trial NCT01116245?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2010-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01116245?
The interventions under investigation include: Placebo Control (DRUG), ADXS11-001 (Lm-LLO-E7) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01116245?
This trial is sponsored by Advaxis, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116245's enrollment target sits among peer trials
81 834th of 2000 higher than 1,159 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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