NCT03185013已完成3 期
A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™-5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 119
- 主要终点
- Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples
研究概览
简要总结
HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 [CIN2] or grade 3 [CIN3]) associated with human papillomavirus (HPV) 16 and/or HPV-18.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 years and above
- •Confirmed cervical infection with HPV types 16 and/or 18 at screening
- •Cervical tissue specimen/slides provided to Study Pathology Adjudication Committee for diagnosis scheduled to be collected within 10 weeks prior to anticipated date of first dose of study drug
- •Confirmed histologic evidence of cervical HSIL at screening
- •Must be judged by Investigator to be an appropriate candidate for the protocol-specified procedure required at Week 36
- •With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with failure rate of less than 1% per year when used consistently and correctly from screening until Week 36
- •Normal screening electrocardiogram (ECG)
排除标准
- •Microscopic or gross evidence of adenocarcinoma-in-situ (AIS), high grade vulvar, vaginal, or anal intraepithelial neoplasia or invasive cancer in any histopathologic specimen at screening
- •Cervical lesion(s) that cannot be fully visualized on colposcopy
- •History of endocervical curettage (ECC) which showed cervical HSIL indeterminate, or insufficient for diagnosis
- •Treatment for cervical HSIL within 4 weeks prior to screening
- •Pregnant, breastfeeding or considering becoming pregnant during the study
- •History of previous therapeutic HPV vaccination
- •Immunosuppression as a result of underlying illness or treatment
- •Receipt of any non-study, non-live vaccine within 2 weeks of Day 0
- •Receipt of any non-study, live vaccine within 4 weeks of Day 0
- •Current or history of clinically significant, medically unstable disease or condition which, in the judgment of the investigator, would jeopardize the safety of the participant, interfere with study assessments or endpoint evaluation, or otherwise impact the validity of the study results
- •Presence of acute or chronic bleeding or clotting disorder that would contraindicate IM injections, or use of blood thinners within 2 weeks of Day 0
- •Participation in an interventional study with an investigational compound or device within 30 days of signing informed consent
- •Less than two acceptable sites available for IM injection
结局指标
主要结局
Percentage of Participants With No Evidence of Cervical HSIL on Histology and No Evidence of HPV-16 and/or HPV-18 in Cervical Samples
时间窗: Week 36
Participants with no histologic (i.e., biopsies or excisional treatment) evidence of cervical HSIL, no evidence of HPV-16 and/or HPV-18 at the Week 36 time frame, and participants in which excision or biopsy sample was not obtained between the initial dose up to Week 36 were considered to be responders. No evidence of HSIL was defined by histology as negative, squamous atypia, or low-grade intraepithelial lesion (LSIL). Cervical samples for HPV-16 and/or HPV-18 were collected using the ThinPrep®.
次要结局
- Change From Baseline in Interferon-Gamma Response Magnitude(Baseline; Week 15 and Week 36)
- Percentage of Participants With No Evidence of Cervical HSIL on Histology(Week 36)
- Levels of Serum Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations(Week 15 and Week 36)
- Percentage of Participants With No Evidence of LSIL or HSIL and No Evidence of HPV-16 and/or HPV-18(Week 36)
- Percentage of Participants With No Progression of Cervical HSIL to Cervical Carcinoma(Week 36)
- Percentage of Participants With No Evidence of LSIL or HSIL on Histology(Week 36)
- Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) Following Investigational Treatment for the Duration of the Study(From baseline up to Week 88)
- Percentage of Participants With No Evidence of HPV-16 and/or HPV-18 in Cervical Samples by Type Specific HPV Testing(Week 36)
- Percentage of Participants Who Have Cleared HPV-16 and/or HPV-18 in Non-cervical Anatomic Locations(Week 36)
- Change From Baseline in Flow Cytometry Response Magnitude(Baseline, Week 15)
研究者
研究点 (119)
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