Trials / Recruiting
RecruitingNCT04131413
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
A Phase I Open Label, Dose Escalation Clinical Trial Assessing the Safety, Tolerability, and Feasibility of pNGVL4aCRTE6E7L2 HPV DNA Vaccine Administration Via Intramuscular TriGridTM Electroporation Delivery System to Patients With HPV16-Positive High-Grade Cervical Intraepithelial Neoplasia
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Accepted
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
- Human Papillomavirus Type 16
- Cervical Intraepithelial Neoplasia Grade II
- Cervical Intraepithelial Neoplasia, Grade III
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pNGVL4aCRTE6E7L2 | The dose escalation will start from the lowest dose level of 0.3 mg. This dose cohort will consist of 3 participants and a monitoring period of one week after the final dose mandated. If there are 0 participants in the 0.3 dose level cohort that experience dose limiting toxicities (DLT), a new cohort of 3 participants will be vaccinated at the 1.0 mg dose level. If there are 0 participants in the 1.0 mg dose level that experience DLT, then a new cohort of 3 participants will be vaccinated at the 3.0 mg dose level. If there is 1 participant experiencing DLTs, an additional cohort of 3 subjects will be enrolled and treated at the current dose level. If there are 2 or more participants experiencing DLTs in the 3 or additional cohort of 3 vaccinated at the current dose level, then the next lower dose level will be determined as the Maximum Tolerated Dose (MTD). |
Timeline
- Start date
- 2020-09-14
- Primary completion
- 2026-12-01
- Completion
- 2028-06-01
- First posted
- 2019-10-18
- Last updated
- 2025-08-24
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04131413. Inclusion in this directory is not an endorsement.