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.
Negative for Intraepithelial Lesions (NEIL), Atypical Squamous Cells of Undetermined Significance (ASC-US), or Low-grade Squamous Intraepithelial Lesion (LSIL) determined by cervical cytology
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.
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.
Crossover
pBI-11 (3 doses)
Biological/VaccinepBI-11 at Day 0, Week 4, Month 7
pBI-11 (1 dose)
Biological/VaccinepBI-11 at Month 7
Placebo (2 doses)
Biological/VaccinePlacebo (saline) vaccine at Day 0, Week 4
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
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
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
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.
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
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
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
Changes in Cytopathology
Changes in cytopathology of specimens taken pre- and post-vaccination by each regimen
Click on the lead sponsor to view all of their trials.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
PapiVax Biotech, Inc.
Collaborator
National Cancer Institute (NCI)
Collaborator
