OncoMatch/Clinical Trials/NCT04131413
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Is NCT04131413 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies pNGVL4aCRTE6E7L2 for human papillomavirus type 16.
Treatment: pNGVL4aCRTE6E7L2 — 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+.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: HPV16 any tested
cervical cytologic samples are HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test
Required: HIV1 any tested (negative)
For the HIV- patient cohort only: patients ... who are HIV negative
Required: HIV1 any tested (positive)
For the HIV+ patient cohort only: patients ... that are HIV positive
Disease stage
Grade: IIIII (CIN)
CIN2/3
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: investigational hpv vaccine
Lab requirements
Blood counts
Absolute neutrophil count > 1,500/mcL; CD4 cell count > 200/mcL; Platelets > 100,000/mcL; Hemoglobin > 10.0 g/dL
Kidney function
Creatinine ≤1.5 x upper institutional limit normal
Liver function
Total bilirubin < 1.5 X upper institutional limit of normal (patients with diagnosed Gilbert's Syndrome will not be excluded if direct bilirubin is within normal institutional limits); AST <1.5 X the upper institutional limit of normal; ALT <1.5 X the upper institutional limit of normal
Participants must have normal organ and marrow function within 45 days of enrollment as defined below: Absolute neutrophil count > 1,500/mcL ... Platelets > 100,000/mcL ... Hemoglobin > 10.0 g/dL ... Total bilirubin < 1.5 X upper institutional limit of normal ... AST <1.5 X the upper institutional limit of normal ... ALT <1.5 X the upper institutional limit of normal ... Creatinine ≤1.5 x upper institutional limit normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Johns Hopkins University · Baltimore, Maryland
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