Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study.
概览
- 阶段
- 4 期
- 干预措施
- GARDASIL®9
- 疾病 / 适应症
- Human Papilloma Virus
- 发起方
- Massachusetts General Hospital
- 入组人数
- 778
- 试验地点
- 3
- 主要终点
- Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18.
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.
详细描述
The HOPE II Study is an individual-level, randomized trial of immediate or delayed vaccination with a single-dose of the nonavalent HPV vaccine. The primary outcome is single-dose HPV 16/18/31/33/45/52/58 vaccine efficacy (VE). The study will provide evidence on the efficacy of single-dose HPV 16/18/31/33/45/52/58 vaccination among women living with HIV. Participants will be randomized 1:1 into two different Groups. * Group 1: Will receive nonavalent HPV vaccine at Day 0 and meningococcal vaccine at Month 18 * Group 2: Will receive the meningococcal vaccine at Day 0 and nonavalent HPV at Month 18 The meningococcal vaccine was chosen as the control vaccination because meningococcal vaccination has no activity against HPV infection. Further, the meningococcal vaccine has the potential to be of benefit in a meningitis outbreak context and could be beneficial for young persons in a congregate setting such as tertiary institutions.
研究者
Ruanne Barnabas, MBChB, MSc, DPhil.
Chief of the Division of Infectious Diseases
Massachusetts General Hospital
入排标准
入选标准
- •Age 16 years and above on the day of signing the ICF
- •Living with HIV with confirmed test results or clinic records
- •History of receiving HPV vaccine
- •Self-reported sexually active in the last six months
- •Lives within the study area and willing to provide updated locator information over the course of the study
- •Does not have an autoimmune, degenerative, or genetic disease
- •Does not have known advanced HIV (as per stage IV WHO clinical staging criteria for HIV)
- •No other Investigator-determined factor would limit participation in the trial
- •Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
- •The participant has a cervix
排除标准
- •Anyone with cervical abnormality on examination
- •Anyone with an allergy to vaccine components or yeast
研究组 & 干预措施
Group 1
Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18
干预措施: GARDASIL®9
Group 1
Will receive GARDASIL®9 vaccine at Day 0 and Menveo®/Menactra® vaccine at Month 18
干预措施: Menveo®/Menactra®
Group 2
Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18
干预措施: GARDASIL®9
Group 2
Will receive the Menveo®/Menactra® vaccine at Day 0 and GARDASIL®9 at Month 18
干预措施: Menveo®/Menactra®
结局指标
主要结局
Efficacy of single-dose HPV among women living with HIV who were vaccinated against HPV 16/18.
时间窗: 18 Months
Efficacy will be measured by the incidence of persistent infection from at least one of these HPV 16/18/31/33/45/52/58, where persistence is defined as a positive test at two consecutive visits at least 4.5 months apart.
次要结局
- Safety and tolerability of single-dose nonavalent HPV vaccination in women living with HIV.(18 Months)