drugset / Trial / NCT04131413
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Phase 1
Recruiting
48 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI) · collab
Non-randomizedSequentialOpen-labelTreatment
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+.
Timeline
- Start
- 2020-09-14
- Primary completion
- 2027-12
- Completion
- 2029-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pNGVL4aCRTE6E7L2 | Vaccine | 0.3 mg | Intramuscular |
| Subject | pNGVL4aCRTE6E7L2 | Vaccine | 1 mg | Intramuscular |
| Subject | pNGVL4aCRTE6E7L2 | Vaccine | 3 mg | Intramuscular |