Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ (NCT06210854) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+
United States48 participantsStarted 2026-07
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* Absolute neutrophil count ≥ 1,500 cells/uL
* Platelets ≥ 90,000 cells/uL
* Hemoglobulin ≥ 9 g/dL
* Total bilirubin \< 3 X the institutional limit of normal
* Aspartate Aminotransferase (AST) and Alanine Aminotransferase(ALT) \< 3 X the institutional limit of normal
* Creatinine \< 2.5 X the institutional limit of normal
* Women of child-bearing potential must agree to use long acting contraception (e.g. tubal ligation, intrauterine device or hormonal implant) or two forms of contraception (e.g. barrier method, oral contraceptives) prior to study entry and for 3 months after final vaccination.
* Ability to understand and the willingness to sign a written informed consent document.
* Able to adhere to the study visit schedule and other protocol requirements.
Exc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety - Frequency and Severity Local Adverse Events and Abnormalities
Timeframe: Post-first study vaccination up to 12 months
2
Safety - Frequency and Severity Systemic Adverse Events and Abnormalities
Timeframe: Post-first study vaccination up to 12 months
3
Safety - Frequency and Severity Solicited Local Adverse Events and Abnormalities
Timeframe: Through 7 days after each study vaccine
4
Safety - Frequency and Severity Solicited Systemic Adverse Events and Abnormalities
Timeframe: At Week 0 up to 7 days post vaccine, At week 4 up to 7 days post vaccine, At 7 months up to 7 days post vaccine
5
Pain Scores assessed by Visual Analog Scale
Timeframe: Week 0, Week 4, 7 months
6
Acceptability as assessed by survey
Timeframe: Week 0, Week 4, 7 months
7
Percentage of participants with no HPV16/18 detection
Trial details
NCT IDNCT06210854
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins