Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

Inclusion Criteria

• Female sex, 25 to 55 years of age

• Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening

• Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.

Exclusion Criteria

• History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia

• Any clinically significant immune suppressing condition

• History or current diagnosis of cervical cancer, suspected or confirmed

• Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.