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Studies

Interventional Recruiting Phase 2

NCT06210854 on ClinicalTrials.gov

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

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

  • Sponsor: Sidney Kimmel Comprehensive Cancer Center
  • Collaborators: PapiVax Biotech, Inc., National Cancer Institute (NCI)
  • Enrollment: 48 (Estimated)
  • Study start: 2026-06-25 (Actual)
  • Primary completion: 2028-11-01 (Estimated)
  • Study completion: 2029-05-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Crossover
  • Masking: Triple (Participant, Care Provider, Investigator)
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Biological: pBI-11 (3 doses)
  • Biological: pBI-11 (1 dose)
  • Biological: Placebo (2 doses)

Primary Outcome Measures

  • Safety - Frequency and Severity Local Adverse Events and Abnormalities (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 (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 (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 (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 (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 (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 (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 (Duration of study, approximately 12 months)
    Percentage of administration procedures where a device fault is observed.
  • Reliability -Percentage of Delays (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.

Countries

United States

Locations and Investigators

  • University of Alabama at Birmingham, Birmingham, United States (Not yet recruiting)
  • Johns Hopkins University, Baltimore, United States (Recruiting)
    • Kimberly Levinson, MD
    • Kimberly Levinson, MD (Principal Investigator)

Study Officials