2026-06-30
notable
Study Status, Contacts/Locations v11
Recruitment opened
Primary completion moved earlier: 2029-03 → 2028-11
Completion moved earlier: 2030-03 → 2029-05
Start dateestimated 2026-07→confirmed 2026-06-25
Study sites1→2
2026-05-26
minor
Study Status, Eligibility v10
Primary completion date2029-03-01→2029-03
Completion date2030-03-01→2030-03
Start date2026-05-01→2026-07
Eligibility criteria+1,135 characters
[...] 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 seiz [...]
2026-03-19
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v9
Primary completion date2028-03-01→2029-03-01
Completion date2028-10-01→2030-03-01
Enrollment target72→48
Study sites0→1
Study arms4→2
InterventionspBI-11 (Drug)→Placebo (2 doses) (Biological), pBI-11 (1 dose) (Biological), pBI-11 (3 doses) (Biological)
Eligibility criteria+138 characters
Inclusion Criteria:
Patients must have:
Negative for Intraepithelial Lesions (NEIL), Atypical Squamo [...] e Eastern Cooperative Oncology Group performance status of 0, or 1 at the time of treatment administrationenrollment.
Patients must have adequate organ function at the time of [...] 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( [...] [...]
Secondary endpoints3 to 4 entries
ImpactEffect of Vaccination3 doses of pBI-11 on Progression to HPV 16HPV16/18 clearance - Percentage of Participants that Exhibit HPV16/18 Positivity (Active arm)
Effect of 1 dose of pBI-11 on HPV16/18 clearance - Percentage of participants that exhibit HPV16/18 positivity (Placebo arm)
Levels of HPV16/18 E6/E7-specific T cells
Primary endpoints3 to 9 entries
EffectAcceptability as assessed by survey
Pain Scores assessed by Visual Analog Scale
Percentage of Vaccinationparticipants with no HPV16/18 detection
FeasibilityReliability - Percentage of VaccinationDevice Faults
Reliability -Percentage of Delays
Safety of- VaccinationFrequency and Severity Local Adverse Events and Abnormalities
Safety - Frequency and Severity Solicited Local Adverse Events and Abnormalities
Safety - Frequency and Severity Solicited Systemic Adverse Events and Abnormalities
Safety - Frequency and Severity Systemic Adverse Events and Abnormalities
Study description-719 characters
This is a randomized double-blind placebo-controlled phase II study with cross-over design.
The primary goal of this study is twothree-fold; one is to determine the safety and tolerabilityfeasibility of three monthlytwo pBI-11 DNA administrations four weeks apart in each thigh of patients with persistent HPV16 and/or HPV18+ < cervical intraepithelial neoplasia 2 (CIN2), wherein either 3.0.1 mL (0.3 mg) of the plasmid DNA is administereddelivered intradermallyvia electroporation mediated intramuscular (I.D.IM) intoadministration each thigh (for a total of 0.6 mg DNA at each visit) using a Pharm [...] [...]
Collaborators+53 characters
PapiVax Biotech, Inc.
National Cancer Institute (NCI)
Study title+16 characters
Assessing Jet Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+