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Investigating pBI-11 for HPV16/18+ Infection

This study is testing an investigational DNA vaccine called pBI-11 to see if it's safe and effective for women with persistent human papillomavirus (HPV) types 16 and/or 18 infection. These HPV types can lead to cervical cancer. You would receive either the pBI-11 vaccine or a placebo (an inactive substance like saline) through an injection into the muscle using a special delivery system. The researchers want to see if pBI-11 can help your body's immune system fight off the HPV infection. They will also be looking at any side effects you might experience. To join, you must be a woman aged 18 or older with HPV16 and/or 18, and have specific cervical cytology results (Negative for Intraepithelial Lesions, Atypical Squamous Cells of Undetermined Significance, or Low-grade Squamous Intraepithelial Lesion).

Study design
This is a randomized, double-blind, placebo-controlled study with a crossover design, planning to enroll 48 participants.
What's involved
You would receive pBI-11 or a placebo at Day 0, Week 4, and/or Month 7. Safety will be monitored for up to 12 months after your first vaccination.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 12 months after your first study vaccination.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06210854

Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+

Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~48 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:pBI-11 (3 doses)pBI-11 (1 dose)Placebo (2 doses)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety - Frequency and Severity Local Adverse Events and Abnormalities
Measured over Post-first study vaccination up to 12 months
+8 more outcomes measured

Conditions

HPV Infection

Explore related trials

Human Papillomavirus InfectionHPV

Where it's being run

2 sites across 2 states
Alabama1
Maryland1

Study leadership

  • Kimberly Levinson, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Kimberly Levinson, MD
[email protected]
410-955-8240
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial Lesion (LSIL) determined by cervical cytology
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.

Exclusion

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).
History of prior malignancy with disease free interval \<5 years; however, individuals with completely resected basal cell or squamous cell carcinoma of the skin within this interval may be enrolled.
Participants with metal implant(s) at the site of injection or any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
Participants with any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child or episode of seizure in pregnancy due to eclampsia.
Participants with syncopal episode within 12 months of screening, excluding fainting for a known and unrelated cause such as anemia which has been resolved.
Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period.
Participants with a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (vastus lateralis muscles with intact lymph drainage) exceeds 50 mm.
Participants in whom the ability to observe possible local reactions at the injection site (lateralis region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.

What this trial measures

  • Safety - Frequency and Severity Local Adverse Events and AbnormalitiesPost-first study vaccination up to 12 months

    Count of the frequency and severity of local adverse events and abnormalities per CTCAE 5.0

  • Safety - Frequency and Severity Systemic Adverse Events and AbnormalitiesPost-first study vaccination up to 12 months

    Count of the frequency and severity of systemic adverse events and abnormalities per CTCAE 5.0

  • Safety - Frequency and Severity Solicited Local Adverse Events and AbnormalitiesThrough 7 days after each study vaccine

    Count of the frequency and severity of solicited local adverse events and abnormalities per CTCAE 5.0

  • Safety - Frequency and Severity Solicited Systemic Adverse Events and AbnormalitiesAt 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

    Count of the frequency and severity of solicited systemic adverse events and abnormalities per CTCAE 5.0.

  • Pain Scores assessed by Visual Analog ScaleWeek 0, Week 4, 7 months

    The mean and standard deviation of the visual analog scale (VAS) based pain scores reported by the participants on the tolerability questionnaire. Scale range 0-10 with higher scores indicating worse pain.

  • Acceptability as assessed by surveyWeek 0, Week 4, 7 months

    The percentage of "Yes" responses to the acceptability question posed in the tolerability questionnaire

  • Percentage of participants with no HPV16/18 detectionAt 6 months post first study vaccine

    Effect of 2 doses of pBI-11 on HPV16/18 clearance. The percentage of participants with no detection of HPV16 or HPV18 in cervical specimens by Roche Cobas test.

  • Reliability - Percentage of Device FaultsDuration of study, approximately 12 months

    Percentage of administration procedures where a device fault is observed.

  • Reliability -Percentage of DelaysDuration of study, approximately 12 months

    Percentage of administration procedures during which a device fault results in a delay in completion of the administration procedure of \> 15 minutes.