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

化学预防药物的 II 期临床研究 - 工作声明 80：AN EX

• 批准号: 7606788
• 负责人: DOROTHY J. WILEY
• 金额: $ 0.27万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-21 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606788
• 关键词: Adjuvant; Antigens; Area; Atypia; Atypical Squamous Cell; Biotechnology; Blinded; Cervical Atypia; Chemoprevention; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Couples; Dose; Eligibility Determination; Funding; Genital system; Goals; Grant; Heat shock proteins; HspE7; Human Papillomavirus; Immune response; Immunotherapy; Infection; Institution; Oncogenic; Outcome; Pap smear; Phase; Placebos; Protocols documentation; Randomized; Rate; Research; Research Personnel; Resources; Source; Squamous intraepithelial lesion; Testing; United States National Institutes of Health; Vaccines; Viral; Week; Woman; Work; comparative; follow-up; interest; macrophage; randomized placebo controlled trial; therapeutic vaccine

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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项工作的总体目的是确定免疫疗法是否可以解决证明温和（宫颈）心脏的女性中的持续生殖性致癌性HPV感染。 为此，该项目的短期目标是测试使用PAP测试证明低级细胞性疾病的女性对生产性HPV类型16（HPV-16）感染的比较疗效。 在这项研究中，感兴趣的暴露是HPV-16 E7/HSP65的三剂疗程 疫苗（由应激生物技术制造的HSPE7）将在免疫和病理上有意义的抗原与热休克蛋白（一种刺激巨噬细胞并促进细胞免疫反应）的抗原伴组合在一起。 感兴趣的结果是宫颈阴道区域的病毒清除率。 这是一项随机，安慰剂对照试验，在研究期间，受试者和研究人员将对治疗分配视而不见。 简而言之，140名女性，假设18至50岁的保留率（即5％的损失损失，4％的损失 - 损失为协议），她们证明低年级的上皮内病变（LSIL）（LSIL）或非典型鳞状细胞在Pap Test上具有较高的较高级别的阳性，并且在Who Pap test hep seld sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil sil，则资格标准将被随机分为三剂，分别为一个月的疫苗或安慰剂。 妇女将在第一次疫苗剂量后的20周和32周内测试HPV-16的存在。