Actively Recruiting
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-08-24
48
Participants Needed
2
Research Sites
402 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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+.
CONDITIONS
Official Title
HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 19 years or older
- Biopsy-confirmed high-grade cervical intraepithelial lesions (CIN2/3) positive for HPV16
- HIV-negative patients with confirmed CIN2/3 lesions or HIV-positive patients with confirmed CIN2/3 lesions
- For HIV-positive patients: documented HIV-1 infection with viral load ≤200 copies/mL and willingness to comply with antiretroviral therapy
- Life expectancy greater than 4 months
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Normal organ and marrow function within 45 days before enrollment, including specified blood counts and liver and kidney function
- Women of childbearing potential must agree to use two forms of contraception, including a barrier method, during the study and for 3 months after completion
- Ability to understand and sign informed consent
- Ability to adhere to study schedule and protocol requirements
You will not qualify if you...
- Patients with high-grade cervical intraepithelial lesions (CIN2/3) that are HPV16 negative
- HIV-positive patients with active AIDS-related infections or viral load >200 copies/mL
- Use of chronic immunosuppressants or immune-modifying drugs within 6 months prior to enrollment
- Active or chronic hepatitis B or C virus infection
- Previous receipt of investigational HPV vaccine
- Receipt of other investigational agents within 30 days prior to registration
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmias, psychiatric or social issues limiting compliance
- History of autoimmune diseases except specified exceptions
- Pregnant or breastfeeding women
- History of allergic reactions to vaccine components
- Presence of metal implants or electronic devices at injection site
- Chronic or active neurological disorders including seizures (except single febrile seizure as a child)
- Syncopal episode within 12 months before screening
- Recent immunoglobulin or blood product administration within 120 days
- Skin-fold measurement at injection site exceeding 40 mm
- Physical conditions obscuring observation of injection site reactions
- Significant hematologic, pulmonary, cardiovascular, hepatic, or renal abnormalities
- History of prior malignancy within 5 years except certain skin cancers
- Inability or unwillingness to sign informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Johns Hopkins University
Baltimore, Maryland, United States, 21231
Actively Recruiting
Research Team
K
Kimberly Levinson, MD
CONTACT
A
Ashish Solanki, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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