A Randomised, Double-Blind, Placebo-Controlled, Phase III Study to Investigate the Efficacy of Presurgical 9-valent HPV Vaccination in Women Treated With LEEP for CIN 2+ and Initially Invasive Cervical Cancer.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,220
- 主要终点
- evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix)
研究概览
简要总结
This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.
详细描述
Rationale:
In 2006 HPV vaccination was licensed for primary prevention programs worldwide. Only a few years after, several studies have raised new scenarios about HPV related diseases with strong implications on clinical management in adult women. Some findings from retrospective data have shown a significant effect of HPV vaccine on women and men treated for HPV pathologies. Although vaccination is not effective in patients with prevalent HPV infection, some studies have suggested that HPV vaccine could influence the incidence of the disease relapse after a surgical treatment. Reduction in disease recurrence after surgical treatment in vaccinated patients comes from gastroenterological, gynecological and dermatological evidences concerning both benign lesions (warts) and precancerous lesions.
If vaccination reduces recurrence rates by 80%, according to our previous pilot study data, peri-surgical HPV vaccination will be a strong effective clinical intervention, very likely to be introduced into standard high grade cervical intraepithelial neoplasia management.
Objective:
The primary objective of the current study is to assess the efficacy of 9-valent HPV vaccination in preventing recurrence of CIN2+ in participants treated for high-grade CIN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Patients aged ≥ 18 and ecog performance status ≤ 1
- •Patients with a diagnosis of high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological results ≥ CIN2 + and ≤ Ia1 according to the FIGO staging of cervical cancer)
- •No fever at the time of vaccination
- •No previous HPV vaccination
- •Ability to understand and write Italian
- •Signed informed and privacy consent
排除标准
- •Patients enrolled in other clinical studies
- •History of allergic reaction or serious adverse events to previous vaccinations
- •Positive pregnancy test at the time of vaccination
- •Patient in treatment with immunosuppressive therapy
- •Subjects who received immunoglobulins or blood products in 3 months prior to vaccination.
- •Thrombocytopenia or any other clotting disorder that may lead to bleeding as a result of intramuscular administration
- •Clinical criteria contraindicating the surgical act of conization
- •ECOG performance status ≥2
研究组 & 干预措施
Gardasil-9
Intramuscular Gardasil-9 vaccination at 0, 2 and 6 months.
干预措施: Gardasil-9 (Biological)
Placebo
Placebo injection at 0, 2 and 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix)
时间窗: 5 years after surgical treatment
evaluation of disease recurrence reduction (cervical intraepithelial neoplasia up to microinvasive cancer of the cervix) by comparing the number of recurrences in the two arms of the study
次要结局
- impact of the vaccine in the post-surgical surveillance times, comparison of viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic picture in the post-operative period(5 years after surgical treatment)
- impact of the vaccine on prevalent post-surgery infections(5 years after surgical treatment)
研究者
Alessandro Ghelardi
Principal Investigator, Department of Obstetrics and Gynaecology Azienda USL Toscana Nord Ovest, Presidio Ospedaliero delle Apuane (MS)- Italy
Azienda USL Toscana Nord Ovest