HPV DNA Vaccine for HPV16 Positive Cervical Neoplasia
This study is testing a new HPV DNA vaccine called pNGVL4aCRTE6E7L2, given with electroporation (a method using electrical pulses to help deliver the vaccine). The main goal is to find out if this vaccine is safe and how well people can tolerate it. You may be able to join if you are an adult woman (19 years or older) with high-grade cervical lesions (CIN2/3) caused by Human Papillomavirus (HPV) type 16. This includes women who are HIV negative or HIV positive. The study will look at how many participants experience side effects at different vaccine doses. The current status of this study is unclear, and it plans to enroll 48 participants.
- Study design
- This is a Phase I, open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 48 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure dose-limiting toxicities at 1 week after the final dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04131413
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Recruiting
PHASE1Ages 19+InterventionalTreatmentSidney Kimmel Comprehensive Cancer Center at Johns HopkinsInvestigator-initiated
~48 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:pNGVL4aCRTE6E7L2
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants experiencing dose limiting toxicities at each dosing level
Measured over 1 week
Conditions
Where it's being run
2 sites across 2 statesAlabama1
Maryland1
Study leadership
- Kimberly Levinson, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
For the HIV- patient cohort only: patients with high-grade cervical intraepithelial lesions (CIN2/3) confirmed by colposcopy and biopsy who are HIV negative
For the HIV+ patient cohort only: patients with high-grade cervical intraepithelial lesions (CIN2/3) confirmed by colposcopy and biopsy that are HIV positive
Patients whose cervical cytologic samples are HPV16+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test or other FDA-approved HPV genotyping test. Co-infections with HPV types other than HPV16 are permissible for study entry.
Age ≥19 years. Also due to Alabama law the age a person is no longer a minor needing parental consent is 19, so all participants need to be 19 or older.
Life expectancy of greater than 4 months.
Baseline Eastern Cooperative Oncology Group performance status of 0, 1 at the time of multi-modality treatment administration
Participants must have normal organ and marrow function within 45 days of enrollment as defined below:
The effects of pNGVL4aCRTE6E7L2 DNA vaccine on the developing human fetus is unknown. For this reason, women of child-bearing potential must agree to use two forms of acceptable contraception, including one barrier method, prior to study entry and for 3 months after study completion. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
Ability to understand and the willingness to sign a written informed consent document.
Participant is able to adhere to the study visit schedule and other protocol requirements.
Exclusion
Patients with high-grade cervical intraepithelial lesions (CIN2/3) that are HPV16 negative
For the HIV+ cohort only: patients with AIDS related symptoms comprising an active AIDS-associated infectious process that, in the view of the investigator, would limit the subject's ability to comply with study procedures.
For the HIV+ cohort only: patients with an HIV viral load \>200 cp/mL.
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry; For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day; inhaled and topical steroids are allowed.
Due to interference with the immunologic measurements and compromising the analysis of the safety of the vaccine, participants with active or chronic infection of hepatitis C virus (HCV) or hepatitis B virus (HBV) are excluded as well as those who have previously received an investigational HPV vaccine.
Participants who are receiving or have received any other investigational agents within 30 days of registration.
Participants with an uncontrolled intercurrent illness including, but not limited to, ongoing or active systemic infection (yeast, bacterial, or viral), symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Participants with a history of autoimmune disease such as systemic lupus erythematosus, celiac disease, autoimmune hepatitis, multiple sclerosis, exclusive of a history of thyroiditis, psoriasis, Sjrogen's, or inflammatory bowel disease.
Pregnant and breastfeeding women are excluded from this study because pNGVL4aCRTE6E7L2 is a vaccine with unknown potential for teratogenic or abortifacient effects.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to pNGVL4aCRTE6E7L2 DNA vaccine.
Participants with a metal implant(s) at the site of injection or any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
Syncopal episode within 12 months of screening.
Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid muscles with intact lymph drainage) exceeds 40 mm.
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, previous EKG, and/or laboratory screening test.
History of prior malignancy \< 5 years; however individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.
Inability to understand or unwillingness to sign an informed consent document.
What this trial measures
- Number of participants experiencing dose limiting toxicities at each dosing level1 week
The safety and tolerability of pNGVL4aCRTE6E7L2 DNA vaccine will be determined using the number of participants experiencing dose limiting toxicities at each dosing level.