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.
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Safety - Frequency and Severity Local Adverse Events and Abnormalities
Timeframe: Post-first study vaccination up to 12 months
Safety - Frequency and Severity Systemic Adverse Events and Abnormalities
Timeframe: Post-first study vaccination up to 12 months
Safety - Frequency and Severity Solicited Local Adverse Events and Abnormalities
Timeframe: Through 7 days after each study vaccine
Safety - Frequency and Severity Solicited Systemic Adverse Events and Abnormalities
Timeframe: 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
Timeframe: Week 0, Week 4, 7 months
Acceptability as assessed by survey
Timeframe: Week 0, Week 4, 7 months
Percentage of participants with no HPV16/18 detection
Timeframe: At 6 months post first study vaccine
Reliability - Percentage of Device Faults
Timeframe: Duration of study, approximately 12 months
Reliability -Percentage of Delays
Timeframe: Duration of study, approximately 12 months