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ABOUT OUR RESEARCH We are interested in how immune responses occur in the cervix. The focus of our translational research is on developing immune therapies for disease caused by human papillomavirus (HPV). HPV infection causes more cancers than any other virus in the world. Cervical cancer is the most common cancer caused by HPV, and although we have known how to screen for it for over half a century, it remains the second most common cause of cancer death in women. Although the preventive vaccines are a public health milestone, they prevent HPV infections, but are not designed to make immune responses to treat HPV. We are testing different strategies to make immune responses that could treat HPV disease. CLINICAL TRIALS An Observational Trial to Evaluate Tissue and Peripheral Immune Responses in Women with HPV-16+ Cervical Intraepithelial Neoplasia – currently enrolling patients OVERVIEW: This study is a brief 15-week observational protocol prior to standard resection of dysplastic lesions. We obtain cervical swabs, and draw a small amount of blood from your arm at study visits. At week 15, patients undergo a cervical LEEP or cone, to remove any residual abnormal tissue. The LEEP or cone are both standard therapies for high grade dysplasia. Over 300 women have participated in this study, to date. No lesions have gotten more severe in the 15-week study window; in fact, we have found that 25% of lesions associated with HPV16 undergo regression in the study window. This study is helping us to determine immune responses in the cervix, and immune responses in the blood. ELIGIBILITY A Phase I efficacy and safety study of HPV16-specific therapeutic DNA-vaccinia vaccination in combination with topical imiquimod, in patients with HPV16+ high grade cervical dysplasia (CIN2/3) – currently enrolling patients OVERVIEW: This study will test a sequence of two different vaccines (one DNA-based, and one vaccinia-based) with or without topical imiquimod at the site of the lesion. Subjects in the first three treatment groups will get vaccinated with experimental vaccines, pNGVL4a-sig/E7(detox)/HSP70, and TA-HPV, before having a cone or LEEP procedure at week 15. Subjects in treatment group 4 will get imiquimod, which is a cream for enhancing immune responses, applied directly to the lesion, before having a cone or a LEEP procedure at week 15. Subjects in treatment group 5 will get vaccinated and also have the cream on their cervix, before having a cone or a LEEP procedure at week 15. There are study specific blood samples and cervical swabs collected before and after vaccination, and at the time of surgery. The vaccines and the cream are provided free of charge to patients in this trial. ELIGIBILITY: CONTACT: A Phase I Study Assessing Safety and Feasibility of pNGVL4a-CRT-E7(detox) Vaccine in Women with Stage IB1 Squamous Cancer of the Cervix (to open in Spring 2009) OVERVIEW: This is a study testing a DNA vaccine in patients with stage IB1 cervical cancer. Patients interested in the study will have their eligibility workup (HPV16 testing, biopsy, and blood tests) prior to undergoing total hysterectomy. After surgery, eligible subjects will be scheduled for vaccination (3 vaccinations scheduled 4 weeks apart). ELIGIBILITY: CONTACT: A Pilot Study of pNGVL4a-CRT-E7(detox) for the Treatment of Patients with HPV16+ Cervical Intraepithelial Neoplasia 3 (CIN3) (to open in Summer 2009) OVERVIEW: This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally. ELIGIBILITY: CONTACT:
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Webmaster: Anna McDonald
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