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

NCT06210854 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: J23124IRB00408026P50CA098252
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HPV Infection

Outcome Measures

Primary Outcomes (9)

• 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

  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

  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

  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.

  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.

  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

  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.

  At 6 months post first study vaccine

• Reliability - Percentage of Device Faults

  Percentage of administration procedures where a device fault is observed.

  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.

  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)

  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)

  At Month 12 post first study vaccine

• Levels of HPV16/18 E6/E7-specific T cells

  At Week 8 post first study vaccine

• Changes in Cytopathology

  Baseline, 6 months, and 12 months post-first study vaccine

Study Arms (2)

Arm 1: pBI-11 + pBI-11 + pBI-11

EXPERIMENTAL

Will receive 3 doses of pBI-11 using the TriGrid Delivery System.

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

Biological: pBI-11 (1 dose); Biological: Placebo (2 doses)

Interventions

pBI-11 (3 doses) BIOLOGICAL

pBI-11 at Day 0, Week 4, Month 7

Also known as: pBI-11 plasmid DNA

Arm 1: pBI-11 + pBI-11 + pBI-11

pBI-11 (1 dose) BIOLOGICAL

pBI-11 at Month 7

Arm 2: Placebo + Placebo + pBI-11

Placebo (2 doses) BIOLOGICAL

Placebo (saline) vaccine at Day 0, Week 4

Arm 2: Placebo + Placebo + pBI-11

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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.

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).
• 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.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• PapiVax Biotech, Inc.: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

NOT YET RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kimberly Levinson, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Levinson, MD

CONTACT

410-955-8240; klevins1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: June 25, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (2)