Randomized, Placebo-controlled Phase 3 Trial to Evaluate Nonavalent HPV Vaccine as a Secondary Prevention in Patients Treated for Human Papilloma Virus Related High-grade Squamous Intraepithelial Lesions
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 984
- 主要终点
- Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.
研究概览
简要总结
Randomized, placebo-controlled phase 3 trial to evaluate nonavalent HPV vaccine as a secondary prevention in patients treated for human papilloma virus related high-grade squamous intraepithelial lesions.
详细描述
BioHPV is a randomized, double-blinded, placebo-controlled, multi-center, phase III trial evaluating nonavalent HPV (9vHPV) vaccine in 984 patients aged ≤55 undergoing HSIL treatment at any site (gynecological (i.e. vulvar, vaginal, cervical), anal, penile).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women, men, transgender,18 ≤age ≤55
- •ECOG performance status ≤ 1
- •Patients infected with HIV are eligible for the study provided they are receiving antiretroviral therapy with undetectable viral load.
- •Biopsy-proven HPV related HSIL at any site (vulvar VIN, vaginal VaIN, cervical CIN, anal AIN, penile PeIN) at baseline.
- •Women of childbearing potential must have a negative urine pregnancy test 24 hours prior to the administration of the first vaccine injection.
- •Sexually active patients must agree to use acceptable and appropriate contraception while included in BIO-HPV study and until the last dose of vaccine.
- •Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- •Patients must be affiliated to a social security system or beneficiary of the same
- •Life expectancy of greater than 5 years
排除标准
- •History of HPV related cancer (i.e. anal, genital, head and neck, cutaneous, penile)
- •History of prior treatment of HSIL
- •Warts so extensive that they preclude the clinician from determining the extent and location of HSIL Prior HPV vaccination
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 21 days prior to the first dose of trial treatment.
- •Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of study treatment.
- •Prior malignancy active within the previous 3 years except from cancers with an expected PFS at 5 years of >95%.
- •Hypersensitivity to the active substances or to any of the excipients (Listed in the SmPC).
- •Acute or severe febrile illness. Vaccination must be postponed until the individual has fully recovered.
- •Pregnant women or intent to become pregnant
- •Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.
研究组 & 干预措施
HPV Vaccine
HPV vaccination, 3 timepoints
干预措施: HPV vaccine (Biological)
Placebo
Placebo vaccination, 3 timepoints
干预措施: Placebo vaccine (Biological)
结局指标
主要结局
Efficacy : Centralised HPV genotyping of the initial HSIL and recurrent lesion will be performed.
时间窗: 4.5 years
To assess the efficacy of Human papilloma virus (HPV) vaccination as secondary prevention in patients with gynecological or anal HSIL.The endpoint will be the time to HPV type-specific recurrence of HSIL at the initial site after completed HSIL treatment.
次要结局
未报告次要终点