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NCT01653249 · ClinicalTrials.gov registry record · Phase 1
A Phase I Clinical Trial of an HPV Therapeutic Vaccine
A Phase 1 study, sponsored by University of Arkansas.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT01653249: Completed Phase 1 study, sponsored by University of Arkansas.
NCT01653249 is a Phase 1 study that has completed, run by University of Arkansas. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01653249, a Phase 1 study, has completed, sponsored by University of Arkansas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This study will consist of 300 women aged 18-50 years. The study will show that a new therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause cervical, vaginal, oral, and anal cancers. This novel vaccine will consist of a synthetically made fragment of HPV protein called E6 and yeast extract called Candin®. Previous studies have revealed that immune response to E6 is important in fighting HPV. We also know that injecting Candin has anti-HPV effect since it has been used to treat common warts which are caused by different types of HPV. The current standard treatment for HSIL is loop electrical excision procedure (LEEP). The immune system is the part of the body that fights infection and cancer. This research study will also examine the immune response to the vaccine and its effectiveness in regressing HSIL. Volunteers would be eligible to enroll in the study if they have had a recent Papanicolaou (Pap) smear result indicating HSIL or "Cannot rule out HSIL", and if they meet the inclusion/exclusion criteria. Subjects will be eligible to receive vaccinations if biopsy confirms HSIL. A series of four vaccinations will be given roughly 3 weeks apart, and LEEP will be performed at the end of the study approximately 12 weeks after the last vaccination.
Primary Outcome
real-time safety measurement of the combined administration of HPV vaccine and Candin® as measured by dose limiting toxicity as defined by adverse events; safety will be assessed at time of vaccination, 30 minutes post-injection, and daily for 7 days post injections.
Interventions
- BIOLOGICAL Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01653249 record still lists
NCT01653249 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which Vaccine consisting of four HPV-16 E6 peptides in combination with Candin® is the first listed.
NCT01653249 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01653249 about?
NCT01653249 is a clinical study titled "A Phase I Clinical Trial of an HPV Therapeutic Vaccine". This study will consist of 300 women aged 18-50 years. The study will show that a new therapeutic human papillomavirus (HPV) vaccine designed to regress a precancerous condition called high-grade squamous intraepithelial neoplasia (HSIL)is safe. HPV is known to cause cervical, vaginal, oral, and ana...
What is the current status of trial NCT01653249?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2012-08. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01653249?
The interventions under investigation include: Vaccine consisting of four HPV-16 E6 peptides in combination with Candin® (BIOLOGICAL).
Who is sponsoring clinical trial NCT01653249?
This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01653249's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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