HPV InfectionPhase 2NCT06210854
Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+
A Phase 2 study testing pBI-11 (3 doses) and pBI-11 (1 dose) in people with HPV Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HPV Infection
- What is being tested?
- pBI-11 (3 doses) and pBI-11 (1 dose)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jun 2026to May 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
Kimberly Levinson, MD, klevins1@jhmi.edu
Kimberly Levinson, MD
- Not yet recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Rebecca Arend, MD, rarend@uabmc.edu
Rebecca Arend, MD
About this study
Official title: Double-Blind Randomized Phase II Clinical Trial Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ <CIN2
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.
Read the detailed description
This is a randomized double-blind placebo-controlled phase II study with cross-over design. The primary goal of this study is three-fold; one is to determine the safety and feasibility of two pBI-11 DNA administrations four weeks apart in patients with persistent HPV16 and/or HPV18+ <CIN2, wherein 3.0 mg of the plasmid DNA is delivered via electroporation mediated intramuscular (IM) administration with the TriGrid Delivery System version 2.0 (TDS-IM v2.0); to evaluate the effect of vaccine on HPV16/18 viral DNA clearance; to evaluate the reliability of the device.
- Conditions
- HPV Infection
- Being tested
- pBI-11 (3 doses), pBI-11 (1 dose), Placebo (2 doses)
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pBI-11 (3 doses)Biological
Also called pBI-11 plasmid DNA
pBI-11 at Day 0, Week 4, Month 7
pBI-11 (1 dose)Biological
pBI-11 at Month 7
Placebo (2 doses)Biological
Placebo (saline) vaccine at Day 0, Week 4
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: pBI-11 + pBI-11 + pBI-11 | Experimental | Will receive 3 doses of pBI-11 using the TriGrid Delivery System. Receives: Biological: pBI-11 (3 doses) |
| Arm 2: Placebo + Placebo + pBI-11 | Experimental | Will receive 2 doses of placebo and 1 dose of pBI-11 using the TriGrid Delivery System Receives: Biological: pBI-11 (1 dose); Biological: Placebo (2 doses) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Frequency and Severity Local Adverse Events and Abnormalities
Count of the frequency and severity of local adverse events and abnormalities per CTCAE 5.0
Measured: Post-first study vaccination up to 12 months
Safety - Frequency and Severity Systemic Adverse Events and Abnormalities
Count of the frequency and severity of systemic adverse events and abnormalities per CTCAE 5.0
Measured: Post-first study vaccination up to 12 months
Safety - Frequency and Severity Solicited Local Adverse Events and Abnormalities
Count of the frequency and severity of solicited local adverse events and abnormalities per CTCAE 5.0
Measured: Through 7 days after each study vaccine
Safety - Frequency and Severity Solicited Systemic Adverse Events and Abnormalities
Count of the frequency and severity of solicited systemic adverse events and abnormalities per CTCAE 5.0.
Measured: 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
Pain Scores assessed by Visual Analog Scale
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.
Measured: Week 0, Week 4, 7 months
Acceptability as assessed by survey
The percentage of "Yes" responses to the acceptability question posed in the tolerability questionnaire
Measured: Week 0, Week 4, 7 months
Percentage of participants with no HPV16/18 detection
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.
Measured: At 6 months post first study vaccine
Reliability - Percentage of Device Faults
Percentage of administration procedures where a device fault is observed.
Measured: Duration of study, approximately 12 months
Reliability -Percentage of Delays
Percentage of administration procedures during which a device fault results in a delay in completion of the administration procedure of > 15 minutes.
Measured: Duration of study, approximately 12 months
Secondary outcomes (4)
Effect of 3 doses of pBI-11 on HPV16/18 clearance - Percentage of Participants that Exhibit HPV16/18 Positivity (Active arm)
The percentage of participants in the active arm that exhibit HPV16/18 positivity by Roche Cobas test
Measured: At Month 12 post first study vaccine
Effect of 1 dose of pBI-11 on HPV16/18 clearance - Percentage of participants that exhibit HPV16/18 positivity (Placebo arm)
The percentage of participants in the placebo arm that exhibit HPV16/18 positivity by Roche Cobas test
Measured: At Month 12 post first study vaccine
Levels of HPV16/18 E6/E7-specific T cells
Magnitude of HPV16/18 E6, and E7 cellular immune responses as assessed by interferon-gamma ELISpot, relative to baseline sample
Measured: At Week 8 post first study vaccine
Changes in Cytopathology
Changes in cytopathology of specimens taken pre- and post-vaccination by each regimen
Measured: Baseline, 6 months, and 12 months post-first study vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start25 Jun 2026
- Primary completionNov 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- PapiVax Biotech, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Levinson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210854
- Sponsor's protocol ID
- J23124
- Other IDs
- IRB00408026, P50CA098252
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Randomized Phase II Clinical Trial Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ <CIN2
- ClinicalTrials.gov ID
- NCT06210854
- Acronym / sponsor ID
- J23124
- Conditions
- HPV Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- PapiVax Biotech, Inc., National Cancer Institute (NCI)
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized double-blind placebo-controlled phase II study with cross-over design. The primary goal of this study is three-fold; one is to determine the safety and feasibility of two pBI-11 DNA administrations four weeks apart in patients with persistent HPV16 and/or HPV18+ <CIN2, wherein 3.0 mg of the plasmid DNA is delivered via electroporation mediated intramuscular (IM) administration with the TriGrid Delivery System version 2.0 (TDS-IM v2.0); to evaluate the effect of vaccine on HPV16/18 viral DNA clearance; to evaluate the reliability of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: pBI-11 + pBI-11 + pBI-11 | Experimental | Biological: pBI-11 (3 doses)Will receive 3 doses of pBI-11 using the TriGrid Delivery System. |
| Arm 2: Placebo + Placebo + pBI-11 | Experimental | Biological: pBI-11 (1 dose), Biological: Placebo (2 doses)Will receive 2 doses of placebo and 1 dose of pBI-11 using the TriGrid Delivery System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pBI-11 (3 doses)Also: pBI-11 plasmid DNApBI-11 at Day 0, Week 4, Month 7 | Biological | Arm 1: pBI-11 + pBI-11 + pBI-11 |
| pBI-11 (1 dose)pBI-11 at Month 7 | Biological | Arm 2: Placebo + Placebo + pBI-11 |
| Placebo (2 doses)Placebo (saline) vaccine at Day 0, Week 4 | Biological | Arm 2: Placebo + Placebo + pBI-11 |
Primary outcome
Safety - Frequency and Severity Local Adverse Events and Abnormalities
Time frame: Post-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 Abnormalities
Time frame: Post-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 Abnormalities
Time frame: Through 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 Abnormalities
Time frame: 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
Count of the frequency and severity of solicited systemic adverse events and abnormalities per CTCAE 5.0.
Pain Scores assessed by Visual Analog Scale
Time frame: Week 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 survey
Time frame: Week 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 detection
Time frame: At 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 Faults
Time frame: Duration of study, approximately 12 months
Percentage of administration procedures where a device fault is observed.
Reliability -Percentage of Delays
Time frame: Duration 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.
4 secondary outcomes
Effect of 3 doses of pBI-11 on HPV16/18 clearance - Percentage of Participants that Exhibit HPV16/18 Positivity (Active arm)
Time frame: At Month 12 post first study vaccine
Effect of 1 dose of pBI-11 on HPV16/18 clearance - Percentage of participants that exhibit HPV16/18 positivity (Placebo arm)
Time frame: At Month 12 post first study vaccine
Levels of HPV16/18 E6/E7-specific T cells
Time frame: At Week 8 post first study vaccine
Changes in Cytopathology
Time frame: Baseline, 6 months, and 12 months post-first study vaccine
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberly Levinson, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pBI-11 (3 doses) and pBI-11 (1 dose) in people with HPV Infection, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Levinson, MD (410-955-8240, klevins1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Frequency and Severity Local Adverse Events and Abnormalities (time frame: Post-first study vaccination up to 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.