OncoMatch/Clinical Trials/NCT04131413
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Is NCT04131413 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04131413 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational hpv vaccine disqualifies patients from enrollment.
Does this trial require HPV16?
Yes, HPV16 any tested is a required biomarker for enrollment.
Does this trial require HIV1?
Yes, HIV1 any tested is a required biomarker for enrollment.
Does this trial require HIV1?
Yes, HIV1 any tested is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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