Evaluation of HPV Vaccine Immunity in High-risk Women: a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Neutralising antibody (NAb) levels to HPV16
研究概览
简要总结
This is a single arm immunological study based in Vietnam. The study will examine human papillomavirus (HPV) vaccine responses in high-risk women (female-sex-worker; FSW). We aim to recruit 60 women (aged 18-25 years old) and provide them with a standard 3-dose schedule of licensed 4vHPV vaccine (Gardasil®, Merck). Blood and cervical swab samples will be collected for immunology and virology testing, respectively.
详细描述
Multiple sexual partners (>4) is a risk factor for human papillomavirus (HPV) infection and cervical cancer. Due to the nature of their work, female sex workers (FSW) are at a particular high risk of HPV infection and developing cervical cancer. These groups are also likely to be reservoirs for HPV transmission since they are less likely to clear the infection and are known to be infected with multiple HPV types simultaneously. Benefits in vaccinating HPV-infected individuals, includes protecting them against HPV vaccine types that the person is not currently infected with as well as re-infection with the same HPV type. Therefore, immunising FSW with HPV vaccine is a novel strategy to reduce their risk of cervical cancer as well as downstream effects on HPV transmission. FSW is common in low-and middle-income countries (LMICs) of Asia (i.e. Vietnam), but the use of HPV vaccine in LMICs is very low often due to high costs and logistical difficulties in vaccine delivery. Furthermore, available data on the immunogenicity of HPV vaccine in FSW are limited. The aim of this study is to determine the immunogenicity of HPV vaccine in FSW and compare their antibody responses among young women (non-FSW) of the same age group by comparison with published data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Each participant must meet all of the following criteria to be enrolled in this trial:
- •Is between the reporting ages of 18-25 years at the time of recruitment
- •Engage in commercial sex in the last month
排除标准
- •Participants meeting any of the following criteria will be excluded from the trial:
- •Pregnant or possibly pregnant
- •Has received any HPV vaccine previously
- •Has an axillary temperate greater than 38°C
- •Known allergies to any vaccine component
- •incapacity to provide consent
结局指标
主要结局
Neutralising antibody (NAb) levels to HPV16
时间窗: 7 months
Geometric mean titres (GMT) of HPV- specific antibody responses to HPV16 at Month 7.
Neutralising antibody (NAb) levels to HPV18
时间窗: 7 months
Geometric mean titres (GMT) of HPV- specific antibody responses to HPV18 at Month 7.
次要结局
- NAb titres to HPV52 and 58 following one dose of Gardasil(Month 2)
- NAb titres to HPV52 and 58 following third dose of Gardasil(Month 7)
- NAb titres to HPV16 and 18 following second dose of Gardasil(Month 3)
- NAb titres to HPV16 and 18 following one dose of Gardasil(Month 2)
- NAb titres to HPV16 and 18 at baseline(Baseline)
- NAb titres to HPV 52 and 58 at baseline(Baseline)
- NAb titres to HPV52 and 58 following second dose of Gardasil(Month 3)
- HPV prevalence rates in FSW at baseline(Baseline)
- HPV prevalence rates in FSW at 7 months(Month 7)
- NAb titres stratified by HPV prevalence at baseline(Baseline)
- HPV prevalence rates in FSW at 2 months(Month 2)
- NAb titres stratified by HPV prevalence at Month 6(Month 7)