Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04131413 · ClinicalTrials.gov registry record · Phase 1
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
A Phase 1 study of Human Papillomavirus Type 16 and Cervical Intraepithelial Neoplasia Grade II, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 2
- Study locations
NCT04131413: Recruiting Phase 1 study of Human Papillomavirus Type 16 and Cervical Intraepithelial Neoplasia Grade II, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04131413 is a Phase 1 study of Human Papillomavirus Type 16 and Cervical Intraepithelial Neoplasia Grade II that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04131413, a Phase 1 study of Human Papillomavirus Type 16 and Cervical Intraepithelial Neoplasia Grade II, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraepithelial (CIN) II or III that is human papillomavirus (HPV) 16+.
Primary Outcome
The safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine will be determined using the number of participants experiencing dose limiting toxicities at each dosing level.
Conditions Studied
Interventions
- DRUG pNGVL4aCRTE6E7L2
Study Locations (2)
Alabama
- University of Alabama at Birmingham - Birmingham
Maryland
- Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2020-09-14 |
| Est. Completion | 2028-06-01 |
| Phase | Phase 1 |
What NCT04131413 shows while recruiting
NCT04131413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 3 conditions, with Human Papillomavirus Type 16 appearing as the primary indexed condition, and to 1 intervention - of which pNGVL4aCRTE6E7L2 is the first listed.
NCT04131413 reports a single indexed study location in Alabama, Maryland.
Frequently Asked Questions
What is clinical trial NCT04131413 about?
NCT04131413 is a clinical study titled "HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia". The primary goal of this phase I open label study is to determine the safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine, as administered by intramuscular (IM) injection with TriGrid™ electroporation to both HIV- or HIV+ adult female subjects (≥ 19 years), with biopsy confirmed cervical intraep...
What is the current status of trial NCT04131413?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2020-09-14. Estimated completion is 2028-06-01.
What conditions does trial NCT04131413 study?
This clinical trial studies the following conditions: Human Papillomavirus Type 16, Cervical Intraepithelial Neoplasia Grade II, Cervical Intraepithelial Neoplasia, Grade III.
What interventions are being tested in trial NCT04131413?
The interventions under investigation include: pNGVL4aCRTE6E7L2 (DRUG).
Who is sponsoring clinical trial NCT04131413?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04131413 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 NCT04131413's enrollment target sits among peer trials
48 1026th of 2000 higher than 948 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01765777 · 48 participants · NA
Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain
- NCT03073343 · 48 participants · NA
A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine
- NCT03431064 · 48 participants
Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients
- NCT03514602 · 48 participants · NA
Maternal Smoking Cessation and Pediatric Obesity Prevention
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI