RecruitingPhase 1NCT04131413

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


Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

48 participants

Start Date

Sep 14, 2020

Study Type

INTERVENTIONAL

Conditions

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+.


Eligibility

Sex: FEMALEMin Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a DNA vaccine delivered using a small electric pulse (called electroporation) to treat high-grade cervical pre-cancer (CIN2/3) caused by the HPV16 virus. Two groups are included: people with and without HIV. **You may be eligible if...** - You are 19 or older - You have been diagnosed with a high-grade cervical lesion (CIN2/3) confirmed by colposcopy and biopsy - Your HPV test is positive for HPV16 - You are either HIV-negative or HIV-positive with a controlled viral load (under 200 copies/mL) and willing to stay on HIV medication - Your blood counts and organ function are within acceptable levels - You agree to use two forms of contraception during and for 3 months after the study **You may NOT be eligible if...** - Your lesion is HPV16-negative - You have HIV with an uncontrolled viral load (over 200 copies/mL) or active AIDS-related illness - You have a pacemaker, deep brain stimulator, or certain metal implants at the injection site - You have a history of seizures or epilepsy - You are pregnant or breastfeeding - You have a history of severe autoimmune disease (except mild thyroid conditions, psoriasis, or inflammatory bowel disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGpNGVL4aCRTE6E7L2

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).


Locations(2)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Johns Hopkins University

Baltimore, Maryland, United States

View Full Details on ClinicalTrials.gov

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NCT04131413