A Non-inferiority Study Comparing the Immunogenicity of a Standard or an Extended Three-dose Nonavalent Human Papillomavirus Vaccine Schedule Between High-risk Women Aged 18-26 Years and Age-matched Women in the General Population
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule
研究概览
简要总结
A Study to evaluate if the 3 dose extended schedule (0-6-18 months) for the HPV vaccine Gardasil-9 provide similar immune responses and short term protection against HPV infection compared to the regular 3 dose schedule (0-2-6 months) in high risk women in Vietnam
详细描述
Primary objective:
To determine whether antibody geometric mean titer (GMT) to vaccine type HPV16 and HPV18 at 7 months (m) are non-inferior between female sex workers (FSW) aged 18-26 years who received the standard (0, 2m, 6m) and those received the extended 3-dose (at 0, 6m and 18m) 9vHPV schedule and age-matched non-FSW who received an extended 3-dose (at 0, 6m and 18m) 9vHPV schedule. This extended 3-dose schedule is in line with the recommended schedule by the vaccine manufacturer in Vietnam.
Secondary objectives:
- To compare antibody GMT at 2m, 7m, 18m and 19m between FSW who are HPV DNA+/seropositive with FSW who are HPV DNA-/seronegative at baseline.
- To compare antibody GMT at 18m and 19m between FSW and non-FSW.
- To determine cellular immune responses to HPV16 and 18 at baseline, 2m, 7m, 18m and 19m.
- To measure incidence and 6m/12m/18m persistent HPV infection.
Primary hypothesis:
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, Outcomes Assessor)
盲法说明
Participants (FSW groups) will be randomly assigned to either of the vaccine schedules and will be given IDs. The link between participant IDs and vaccine groups are only known by Investigator.
Barcodes will be used for samples and no personal identification nor participant ID is allowed in the samples.
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Is between the reporting ages of 18-26 years at the time of recruitment.
- •Engage in commercial sex in the last 6m (for FSW group) or have engaged in sexual activity (non-FSWs)
- •Willing and able to give written informed consent.
- •Willing to complete the follow-up requirements of the study.
- •Exclusion criteria
- •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
- •Currently receiving immunosuppressive medication or anti-cancer chemotherapy.
- •Known HIV infection.
- •Known Congenital immune deficiency syndrome.
排除标准
- 未提供
研究组 & 干预措施
Group 1 FSW
100 FSWs aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months
干预措施: Human papillomavirus 9-valent vaccine, Recombinant (Biological)
Group 2 non-FSW
100 non-FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-6-18 months
干预措施: Human papillomavirus 9-valent vaccine, Recombinant (Biological)
Group 3 FSW
100 FSW aged 18-26 years receiving 3 doses of Gardasil-9 vaccine at 0-2-6 months
干预措施: Human papillomavirus 9-valent vaccine, Recombinant (Biological)
结局指标
主要结局
Comparison between antibody responses after the 3rd dose ofregular vaccine schedules among FSW and after the 2nd dose of the extended schedule
时间窗: 7 months from the first doses
geometric mean titer (GMT) ratios and 95% confidence intervals (CI) of HPV- specific antibody responses to HPV16 and HPV18 at 7m between FSWs aged 18-26 years who received either the standard (0, 2m, 6m) or extended 3-dose (at 0, 6m and 18m) 3-dose 9vHPV schedule and age-matched non-FSWs who received the extended 3-dose 9vHPV schedule (at 0, 6m and 18m).
次要结局
- Comparison of antibody responses after each doses among FSW according to HPV infection status pre-vaccination(19 months after the 1st doses)
- Comparison of antibody response after 3 doses of extended schedule between FSW and non-FSW(19 month after the first doses)
- Celular response after each vaccine dose(19 months after the 1st dose)
- HPV persistent during 19 month or more among vaccines(at least 19 months after the first dose)
研究者
Nguyen Van Trang
Acting Manager, Center for Biomedical Researches
National Institute of Hygiene and Epidemiology, Vietnam