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NCT03913117 · ClinicalTrials.gov registry record · Phase 1
Study of Treatment for HPV16+ ASC-US or LSIL
A Phase 1 study of ASC-US and LSIL, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT03913117: Recruiting Phase 1 study of ASC-US and LSIL, sponsored by University of Alabama at Birmingham.
NCT03913117 is a Phase 1 study of ASC-US and LSIL that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03913117, a Phase 1 study of ASC-US and LSIL, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine
Primary Outcome
To determine the safety and feasibility of intra-muscular administration of pNGVL4aCRTE6E7L2 DNA vaccine in patients with persistent HPV16+ ASC-US/LSIL
Interventions
- BIOLOGICAL pNGVL4aCRTE6E7L2
- BIOLOGICAL TA-CIN
Study Locations (2)
Alabama
- UAB | The University of Alabama at Birmingham - Birmingham
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-07-10 |
| Est. Completion | 2027-09 |
| Phase | Phase 1 |
What NCT03913117 shows while recruiting
NCT03913117 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 2 conditions, with ASC-US appearing as the primary indexed condition, and to 2 interventions - of which pNGVL4aCRTE6E7L2 is the first listed.
NCT03913117 reports a single indexed study location in Alabama, Maryland.
Frequently Asked Questions
What is clinical trial NCT03913117 about?
NCT03913117 is a clinical study titled "Study of Treatment for HPV16+ ASC-US or LSIL". Phase I clinical trial to assess safety of pNGVL4aCRTE6E7L2 DNA and TA-CIN protein vaccinations, and to seek the appropriate dose of the pNGVL4aCRTE6E7L2 DNA vaccine
What is the current status of trial NCT03913117?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-07-10. Estimated completion is 2027-09.
What conditions does trial NCT03913117 study?
This clinical trial studies the following conditions: ASC-US, LSIL.
What interventions are being tested in trial NCT03913117?
The interventions under investigation include: pNGVL4aCRTE6E7L2 (BIOLOGICAL), TA-CIN (BIOLOGICAL).
Who is sponsoring clinical trial NCT03913117?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03913117 being conducted?
This trial has 2 study locations across Alabama, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03913117's enrollment target sits among peer trials
30 1333rd of 2000 higher than 561 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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