Prospective Analysis of Immunogenicity of the Nonavalent Human Papillomavirus Vaccination (GARDASIL 9) in Patients Post Solid Organ Transplant
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Primary Outcome
研究概览
简要总结
To measure levels of HPV antibodies in post-solid-organ transplant recipients who have gotten the HPV9 vaccine.
详细描述
This is a prospective open-label nonrandomized single-center cohort study aimed to analyze the immunogenicity of nanovalent human papillomavirus vaccination (GARDASIL 9) in post-solid-organ transplant patients.
The study duration is anticipated to be 36 months. The expected duration of subject participation is 24 months. Immunocompromised populations are at greater risk of HPV infection. Quadrivalent HPV vaccination has been performed and lower titers of antibodies have been compared to published date in non-immunocompromised population (controls). The HPV9 vaccination titers have not been measured in the immunocompromised population to date.
We plan to enroll 30 adult solid-organ transplant recipients ages 18-45 years >6 months from transplant receiving treatment at clinics at F&MCW Main Campus.
Patients will be scheduled to receive 3-dose 9vHPV vaccination (vaccination at enrollment [time 0], 2 months [+ 6 weeks], and 6 months [+ 6 weeks] per standard guidelines).
Serial serum samples will be obtained for geometric mean titers (GMT) prior to vaccination, at 7 months (+ 6 weeks), 12 months (+ 6 weeks), and 24 months (+ 6 weeks) after completion of the vaccination series. If a patient is subsequently scheduled to undergo a transplant, we will obtain the GMT prior to the transplant.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between the age of 18 and 45 years
- •Patient is at least 6 months post-solid-organ transplant and has not received GARDASIL
- •Patient who can participate in their health care and sign informed consent.
- •Patient may have had bivalent or quadrivalent HPV vaccination previously.
- •Living or deceased donor transplant patient is eligible.
排除标准
- •Contraindication: Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL 9 or GARDASIL.
- •Patient had completed vaccination series with a nonavalent HPV vaccine (e.g., GARDASIL 9) in the past
- •Patient with a diagnosis of HIV.
- •Patient that endorses being currently pregnant.
研究组 & 干预措施
Interventional
Patient between the age of 18 and 45 years with at least 6 months post-solid-organ transplant who has not received GARDASIL 9.
干预措施: Human Papilloma Virus vaccine (GARDASIL 9) (Biological)
结局指标
主要结局
Primary Outcome
时间窗: 7 months, 12 months and 24 months
The primary outcome is to measure immunogenicity using the Merck proprietary Competitive Luminex Immunoassay (cLIA) and geometric mean titers (GMTs) over specified time intervals (7 months, 12 months and 24 months from vaccination) in patients to each of the nine human papillomavirus types contained in the nanovalent human papillomavirus vaccine (HPV9) vaccination and compare these antibody levels to published control data for non-immunocompromised individuals. this has been completed previously for the quadrivalent HPV vaccination series but no data exists for the HPV9 vaccination in this population. We will also compare GMTs in our study patients and over time to determine if there is a difference between timing of vaccine administration.
次要结局
- Secondary Outcome(7 months, 12 months and 24 months)
研究者
Denise Uyar
Professor
Medical College of Wisconsin