SGN-00101 Vaccine in Treating Human Papillomavirus in Patients Who Have Abnormal Cervical Cells

Inclusion Criteria:

• Meets criteria for 1 of the following groups:

  • Prospective group, meeting the following criteria:

    • Evidence of atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL) by Pap test
    • Human papillomavirus (HPV)-16-positive by polymerase chain reaction (PCR) and PGMY09/PGMY11 oligonucleotide primers viral load assay

  • Medical records-based group, meeting the following criteria:

    • Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months

    • Meets 1 of the following criteria:

      • Liquid-cytology findings of ASCUS or LSIL
      • Colposcopic evidence of a LSIL by the Reid Index score of 1-5
    • Historically persistent HPV-16-infection by PCR and HPV reverse transcription (RT)-PCR
    • No evidence of high-grade squamous intraepithelial lesions (HSIL) by colposcopy (Reid Index ≥ 6)
    • Reports no sex partner change since last index Pap screening test

  • Specimen-based group, meeting the following criteria:

    • Medical-record evidence of ASCUS or LSIL by Pap test within the past 6-12 months

      • Liquid-based cytology specimen available

    • Meets 1 of the following criteria:

      • Liquid-cytology findings of ASCUS or LSIL
      • Colposcopic evidence of a LSIL by the Reid Index score of 1-5
    • Historically persistent HPV-16-infection by PCR and, where measurable, HPV RT-PCR showing no greater than 3-fold reduction over the index liquid-cytology specimen
    • No evidence of HSIL by colposcopy (Reid Index ≥ 6)
• Menstrual period occurred at least once within the past 52 weeks
• No HSIL by Pap test within the past year
• Performance status - ECOG 0
• No severe or unstable coagulation
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative
• No angina
• No heart failure
• No other cardiac condition
• No respiratory condition
• No asthma
• No immunological disorders (e.g., lupus, diabetes, multiple sclerosis, or myasthenia gravis)
• Not immunocompromised, suggestive of severe immune deficiency
• HIV negative
• No AIDS
• No active infection, defined as fever > 100° F
• No syphilis
• No severe allergic reactions (anaphylactic response) to drugs or any other allergen
• No history of allergy to any vaccine constituents, including cell- or tissue-system elements used to prepare the vaccine (e.g., bread products, yeast, or recombinant DNA technology using yeast systems)
• Must agree to use effective form of contraception throughout vaccination period
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during vaccination period and for 5 months after study treatment
• No sexual intercourse within 48 hours of virus specimen collection during study visits
• No objects (e.g., tampons, douche, suppositories, fingers, or toes) within the vagina or rectum within 48 hours of virus specimen collection during study visits
• No prior malignancy except nonmelanoma skin cancer
• No medical or psychiatric illness than would preclude study participation or compliance
• No other disorders requiring medical intervention that would preclude study participation
• No prior HPV vaccine
• More than 30 days since prior investigational vaccine
• More than 30 days since prior systemic steroid therapy
• No prior splenectomy
• More than 30 days since prior investigational drug
• More than 72 hours since prior antibiotic therapy for active infection