Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+
Eligible age
18+ yrs
Accepts
Women
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This research is being done to test the safety and feasibility of an investigational DNA vaccine called pBI-11 and to find out what effects, if any, it has on women with persistent human papillomavirus 16 (HPV16+) and/or human papillomavirus (HPV18+) cervical infection. The DNA vaccine is designed to promote an immune response to treat disease caused by HPV types 16 and 18, viruses that can cause cervical cancer. The pBI-11 DNA vaccine or a placebo will be administered intramuscularly using the TriGridTM Delivery System.
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
You may qualify if…
- ✓ Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial Lesion (LSIL) determined by cervical cytology
- ✓ AND
- ✓ HPV16 and/or 18+ by Roche Cobas 4800, Roche Linear Array HPV Genotyping test, or other FDA-approved HPV genotyping test (Co-infections with HPV types other than HPV16/18 are permissible).
- ✓ Age ≥ 18 years
- ✓ Baseline Eastern Cooperative Oncology Group performance status of 0 or 1 at the time of enrollment.
- ✓ Patients must have adequate organ function at the time of enrollment as defined by the following parameters:
- ✓ White blood cell count ≥ 3,000 cells/uL
- ✓ Absolute lymphocyte number ≥ 500 cells/uL
You may not qualify if…
- ✕ Histologic evidence of CIN2, cervical intraepithelial neoplasia 3 (CIN3), adenocarcinoma in situ or malignancy.
- ✕ Patients with a diagnosis of immunosuppression or active systemic use of immunosuppressive medications such as steroids.
- ✕ Patients who are receiving any other investigational agents within 28 days prior to the first dose of study vaccine.
- ✕ Patients with an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- ✕ Patients with a history of systemic autoimmune disease such as multiple sclerosis or systemic lupus erythematosus (SLE), but exclusive of a history of thyroiditis, psoriasis, Sjogren's, or inflammatory bowel disease.
- ✕ Patients who are pregnant or breast feeding or plan to become pregnant within 12 months of first study treatment.
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to pBI-11 DNA vaccine.
- ✕ Patient with active infection of, or receiving treatment for Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV).
Where it's recruiting
Source: ClinicalTrials.gov · NCT06210854 · last updated 2026-07-01