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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
pBI-11 at Day 0, Week 4, Month 7
pBI-11 at Month 7
Placebo (saline) vaccine at Day 0, Week 4
University of Alabama at Birmingham
Birmingham, Alabama, United States
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
Time frame: 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
Time frame: 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
Time frame: 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.
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
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.
Time frame: 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
Time frame: 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.
Time frame: At 6 months post first study vaccine
Reliability - Percentage of Device Faults
Percentage of administration procedures where a device fault is observed.
Time frame: 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.
Time frame: Duration of study, approximately 12 months
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
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)
The percentage of participants in the placebo arm that exhibit HPV16/18 positivity by Roche Cobas test
Time frame: 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
Time frame: At Week 8 post first study vaccine
Changes in Cytopathology
Changes in cytopathology of specimens taken pre- and post-vaccination by each regimen
Time frame: Baseline, 6 months, and 12 months post-first study vaccine
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