RecruitingHuman Papillomavirus Type 16Cervical Intraepithelial Neoplasia Grade IICervical Intraepithelial Neoplasia, Grade III
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Eligible age
19+ yrs
Accepts
Women
Locations
2 states
Healthy volunteers
Yes
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About this study
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+.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ 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
- ✓ 1. HIV-1 infection, as documented by a rapid HIV-1 test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by western blot at any time prior to study entry.
- ✓ 2. Two HIV-1 RNA values ≤200 copies/mL at least 24 hours apart performed by any laboratory that has Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent may be used to document infection.
- ✓ 3. Patients must be willing to comply with effective Antiretroviral Therapy.
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT04131413 · last updated 2025-08-24