An Exploratory Study to Evaluate the Effect of HPV 16 Vaccine on the Reduction of Viral Load in HPV 16 Positive Women With Persistent Viral Infection, But Low Grade Disease (ASCUS/LSIL)

Date de début de l'étude : 1 septembre 2004

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