Recombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Anti-glycoprotein E antibody Concentration
研究概览
简要总结
This goal of this study is to assess the safety and immunogenicity of recombinant zoster virus in young adult solid organ transplant recipients. In this study, participants will receive the recombinant zoster vaccine. They will be monitored for adverse events and tested for antibody and cellular immunity.
详细描述
This is an open-label, non-blinded study to assess the safety and immunogenicity of the Recombinant Zoster Vaccine (RZV) in young adult recipients of solid organ transplants (heart, liver, kidney). After obtaining consent, the patient will have pre-vaccine baseline Varicella Zoster Virus (VZV) anti-gE antibody testing performed by the Weinberg lab and then will be given first dose of vaccine. Participants will be brought back 30-60 days post-vaccine for follow up testing and second dose of vaccine. Participants will then be brought in for follow-up testing at 1-2 months, 6 months, and 12-15 months after receiving 2nd dose of vaccine. Testing for both antibody and cellular immunity to VZV will be performed throughout the study. Telephone, electronic and in-person follow up will be conducted to assess for any clinical signs of VZV reactivation, any vaccine-related side effects or any signs of acute rejection.
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
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older and willing to provide written informed consent for the study participation.
- •Prior recipient of solid organ transplant more than one year prior to participation.
- •Stable immunosuppressive medication regimen for last 6 months prior to participation
- •Participant must have a working telephone number, email address or patient Electronic Health Record (EHR) portal access and be willing to be contacted for study follow-up by any of these means.
- •For participants of childbearing potential, use of effective pregnancy prevention till 2 months post last dose.
排除标准
- •Active treatment with corticosteroids or other immunosuppressive agents for acute or chronic rejection.
- •More than 2 courses of treatment for acute rejection within last 2 years prior to study enrollment
- •History of anaphylaxis or other allergic reaction after receiving prior vaccinations or vaccine components
- •Receipt of any inactivated vaccine 8 days before/after dose #1, subunit vaccine 14 days before/after dose #1 and live, attenuated or mRNA vaccine 30 days before/after dose #1
- •History of herpes zoster, primary varicella or VZV vaccination within past 1 year prior to study entry
- •Active pregnancy as defined by positive pregnancy test at the time of screening and prior to each dose of vaccine
- •Febrile illness with Temp ≥39°C and/or infection that require hospitalization or oral antibiotics/antivirals/antifungal/anti-parasite medication within 14 days prior to day
- •Any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
研究组 & 干预措施
Recombinant Zoster Vaccine Administration and Testing
all participants will receive 2 doses of recombinant zoster vaccine (Shingrix)
干预措施: Recombinant Zoster Vaccine (Biological)
结局指标
主要结局
Anti-glycoprotein E antibody Concentration
时间窗: 30-60 days
Percentage of vaccinees with 4-fold rise in anti-glycoprotein E antibody concentration
Adverse Event Reporting
时间窗: 30 days-1 year
Percentage of vaccinees with any adverse event (AE) reported as well as those related to receipt of each dose of a 2-dose series of Recombinant Zoster Vaccine (RZV), to be analyzed within the following categories 1. Adverse Events of Special Interests (AESI) including local reactions, clinically diagnosed rejection, or varicella disease through the end of the study period (one year post dose 2) 2. Serious Adverse Events (SAEs) through the end of the study period (one year post dose 2) 3. Potential Immune Mediated Diseases (pIMDs) through the end of the study period (one year post dose 2) 4. Any AE present within 30 days of vaccine administration (dose 1 or dose 2) or pregnancy at any point during the study
次要结局
- Acute Rejection Reporting(2 months)
- Glycoprotein E-Specific Cellular Responses(30-60 days)
研究者
Ravi Jhaveri
Division Head of Pediatric Infectious Diseases, Principal Investigator
Ann & Robert H Lurie Children's Hospital of Chicago