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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 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. The trial reports 2 study locations across 2 states.
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+.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04131413
The ClinicalTrials.gov registry entry for NCT04131413 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Human Papillomavirus Type 16
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Cervical Intraepithelial Neoplasia Grade II
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Alabama
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