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