This randomized, double-blind, placebo-controlled, parallel arm study will assess the safety and the efficacy of RO5217790 on histologic resolution in participants with high grade CIN associated with HR-HPV infection. Participants will be randomized to receive 3 subcutaneous injections of either placebo or RO5217790 on Days 1, 8, and 15. Study assessments will be made at Baseline, at Month 3 and 6, and every 6 months thereafter for an overall of 2.5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
206
Placebo matched to RO5217790 will be administered subcutaneously on Days 1, 8, and 15.
RO5217790 will be administered at a dose of 5\*10\^7 pfu subcutaneously on Days 1, 8, and 15.
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Percentage of participants with CIN2/CIN3 associated with HPV16 single infection who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
Time frame: Month 6
Percentage of participants who achieved Histologic resolution (Defined as no CIN), determined by evaluation of tissue derived from surgical excision
Time frame: Months 6
Percentage of participants who achieved Histologic response (Defined as CIN Grade less than [<] 2), determined by evaluation of tissue derived from surgical excision
Time frame: Month 6
Percentage of participants with viral clearance based on Roche Linear assay results
Time frame: Months 3 and 6
Percentage of participants with immunologic response to HPV antigens
Time frame: Day 1 (predose), Days 8, 15, and 29, Months 3 and 6
Percentage of Participants with at least one Adverse Events (AEs)
Time frame: Up to Month 30
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Colton, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Colorado Springs, Colorado, United States
Unnamed facility
Stamford, Connecticut, United States
Unnamed facility
Washington D.C., District of Columbia, United States
...and 56 more locations