Inclusion Criteria:

• A female subject of childbearing potential who is sexually active using contraception.
• Subject is willing to abstain from all sexual contact involving her genitalia for at least 24 hours prior to and 24 hours after study drug administration.
• Subject must be neither pregnant nor lactating from Screening throughout the duration of the study.

• Subject has 1 of the following:

  • Menstruating with a stable cycle and has at least 21 non-bleeding days.
  • Amenorrheic (due to injectable or extended-cycle contraceptives).
• Subject is willing to refrain from using vaginal douche products during the treatment period and through the Follow-up Month 4 visit.
• Subject has a Pap test interpretation of either low-grade squamous intraepithelial lesions or atypical squamous cells of undetermined significance.
• Subject has a uterine cervical sample that is high-risk human papillomavirus positive.

Exclusion Criteria:

• The Subject has evidence of an uncontrolled, clinically significant medical condition as determined by the investigator.
• The Subject has a history of hemorrhagic diatheses or coagulopathy.
• The Subject has a history of toxic shock syndrome.

• The Subject has received any of the following medications in the timeframes listed below:

  • 851 (in any form) or an active (non-placebo) human papillomavirus vaccine at any time prior to the screening visit.

  • In the 4 weeks prior to the screening visit the subject has received:

    • Interferon therapy or other therapies that promote a proinflammatory immune state, including:

      • immunomodulators.
      • cytotoxic drugs.
      • drugs known to have major organ toxicity.
    • Used a vaginal douche 72 hours prior to the screening visit.
    • Received any investigational drug within 60 days of Study Day 1.

    • Used in the 2 weeks prior to Study Day 1:

      • oral or inhaled corticosteroids (>1000 mcg/day, fluticasone propionate >600 mg/day, or equivalent).
      • systemic steroids.
      • topical drugs to the anogenital area.
      • NuvaRing.
• The Subject has a history of hypersensitivity to any components of the gel formulation or to iodine.
• The Subject has given birth or has had a spontaneous or induced abortion within 2 months of Study Day 1.
• The Subject uses an intrauterine device, diaphragm, NuvaRing, or additional contraceptive foam or gel for birth control.

• The Subject has:

  • histology read as high-grade cervical intraepithelial neoplasia.
  • cytology read as high-grade squamous intraepithelial lesion.
  • cytology read as atypical glandular cytological abnormalities.
  • cytology read as atypical squamous cells - cannot exclude high grade.
  • cervical carcinoma of any type.
  • apparent endocervical involvement.
  • high-grade vulvar intraepithelial neoplasia.
  • high-grade vaginal intraepithelial neoplasia.
• If the limits of a cervical lesion cannot be readily visualized.
• If the limits of the transformation zone cannot be readily visualized.
• The subject has clinical evidence of a vaginal infection or sexually transmitted infection, other than cervical human papillomavirus infection at the Study Day 1 visit.
• The Subject has had a cervical biopsy within 1 month prior to the screening visit.
• The Subject has had any previous ablative or surgical treatment of the cervix within 3 months prior to the screening visit;
• The Subject has a history of alcoholism or substance abuse within 1 year or has current alcohol or substance abuse as assessed by the investigator.
• The Subject has tested positive for human immunodeficiency virus at the screening visit or has evidence of any other immunosuppressive disease.