PHASE II CLINICAL STUDIES OF CHEMOPREVENTION AGENTS - WORKSTATEMENT 80: AN EX

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall goal of this work is to determine whether an immunotherapy can resolve persistent genital oncogenic HPV infection in women who evidence mild (cervical) atypias. To this end, the short term goal of this project is to test the comparative efficacy of a therapeutic vaccine for productive HPV Type-16 (HPV-16) infection among women who evidence low-grade cellular atypias using Pap test. For this study, the exposure of interest is a three-dose course of HPV-16 E7/HSP65 vaccine (HspE7 made by Stressgen Biotechnologies), that couples together antigens that are immunologically and pathologically meaningful (E7) with heat shock protein, an adjuvant that stimulates macrophages and promotes cellular immune responses. The outcome of interest is viral clearance from the cervicovaginal area. This is a randomized, placebo-controlled trial where both subjects and the investigators will be blinded to treatment assignment for the duration of the study. Briefly, 140 women, assuming a 91% retention rate (i.e. 5% loss-to-follow-up, 4% loss-to-protocol-violation) who are 18 to 50 years old, who evidence low grade squamous intraepithelial lesions (LSIL) or atypical squamous cells of unknown significance (ASCUS) on Pap test, who test positive for HPV-16, who have not evidenced high grade SIL in the prior year and who meet other eligibility criteria will be randomized to receive vaccine or placebo in three doses, spaced one month apart. Women will be tested for the presence of HPV-16 at 20 and 32 weeks following their first vaccine dose.