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