KINETICS AND ECOLOGY OF HUMAN PAPILLOMAVIRUS (HPV) GENITAL INFECTIONS IN YOUNG WOMEN
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Times series of HPV virus load in cervical smears measured by qPCR
研究概览
简要总结
Most genital infections by human papillomaviruses (HPV) are asymptomatic or benign and clear within a few months or years. There infections are much less studies than chronic infections, even though they represent the main reservoir for the virus. The goal of this project is to decipher the kinetics of the virus and of the host immune response in acute HPV genital infections in your women. This will be performed by following women longitudinally and regularly in order to measure variations in virus load, immune cell count, cytokine concentration and antibody titers. The investigators will also investigate the interaction between these kinetics and host genetics and host vaginal microbiota
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active with at least one new partner over the last 12 months
- •Subjects must be able and willing to give written informed consent
- •Living in the 'agglomération de Montpellier'
排除标准
- •History of cervical pathology
- •Pregnant or intending to become pregnant soon (in the coming year)
- •Infected by HIV
- •Undergoing (or planning to undergo) heavy treatment (biotherapy, chemotherapy, immunosuppression)
- •Participation in a clinical trial involving administration of drugswithin the last 4 weeks before the screening date
结局指标
主要结局
Times series of HPV virus load in cervical smears measured by qPCR
时间窗: from detection to clearance or persistence (i.e. 3 to 24 months)
This time series will be used to calibrate a general model capturing HPV kinetics in genital acute infections in young women. At every time point, other measures such as temperature, vaginal pH, coinfections will be performed and women will fill-in detailed questionnaires about their every day life (vaccination status, antibiotic treatments, sexual activity) to control for co-factors. Virus genetics, host genetics (SNPs), immunophenotyping and microbiota will also be surveyed as cofactors.
次要结局
- Times series of local innate and adaptive immune cell densities in cervical smears counted using Flow Cytometryor clearance)(from detection to clearance or persistence (i.e. 3 to 24 months))
- Times series of vaginal cytokine densities measured using MesoScale Discovery technique(from detection to clearance or persistence (i.e. 3 to 24 months))
- Times series of anti-HPV circulating antibody titers(from detection to clearance or persistence (i.e. 3 to 24 months))
- Times series of the vaginal microbiota determined using 16S RNA and shotgun sequencing(from detection to clearance or persistence (i.e. 3 to 24 months))