This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18 associated Cervical intraepithelial neoplasia grade 2/3 or 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
167
1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit.
Time frame: 36 weeks
Number of Participants with Virologically-proven Clearance of HPV 16 or 18 in Combination with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Secondary Measure of Efficacy
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less and have virologically-proven clearance of HPV16 or HPV18 at the 36 week visit.
Time frame: 36 Weeks
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Colton, California, United States
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La Mesa, California, United States
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Los Angeles, California, United States
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Lakewood, Colorado, United States
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Boynton Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Sarasota, Florida, United States
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Baltimore, Maryland, United States
...and 33 more locations