Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine Before and After Lung Transplantation
试验速览
- 阶段
- 4 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.
研究概览
简要总结
The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
详细描述
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for reactivation of all herpesviruses including VZV. Epidemiologic studies show the cumulative incidence in lung transplant recipients of reactivation to be 15-20%. A non-live, recombinant subunit vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older. The investigators plan to study the immunogenicity of the vaccine before and after lung transplantation. Patients (at least 50 years old) before and after lung transplantation will be enrolled. The investigators hypothesize that the recombinant varicella-zoster subunit vaccine is able to induce cellular immunogenicity after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-Transplant Vaccine Group:
- •Single or double lung transplant recipient.
- •Age ≥50 years
排除标准
- •Post-Transplant Vaccine Group:
- •Has already received varicella zoster subunit vaccine in the past
- •Shingles within the last 12 months
- •Ongoing CMV viremia > 200 IU/mL
- •HIV infection
- •Diagnosis of malignancy (eg PTLD)
- •Inclusion Criteria Pre-Transplant Vaccine Group:
- •On waiting list for lung transplantation
- •Age ≥50 years
- •Exclusion Criteria Pre-Transplant Vaccine Group:
- •Has already received Shingrix or Zostavax (live shingles vaccine) in the past
- •Systemic prednisone ≥20 mg per day (or equivalent dose of any corticosteroid)
- •Other (than prednisone < 20mg per day or equivalent dose of any corticosteroid) systemic immunosuppressive therapy such as mycophenolate or tacrolimus
- •Shingles within the last 12 months
- •HIV infection
研究组 & 干预措施
Pre-Transplant Group
VZV Subunit vaccine will be administered
干预措施: VZV subunit vaccine (Biological)
Post-Transplant Group
VZV Subunit vaccine will be administered
干预措施: VZV subunit vaccine (Biological)
结局指标
主要结局
Cellular immunity to varicella zoster induced by varicella zoster subunit vaccine.
时间窗: 4 weeks after second dose of vaccine
Cellular immunogenicity against VZV induced by varicella zoster subunit vaccine in lung transplant recipients measured as a percentage of CD4+ and CD8+ T-cells measured by intracellular flow-cytometry based staining. The cellular immunogenicity of the vaccine in lung transplant recipients will be compared to the control group (pre-transplant vaccination).
次要结局
- Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in lung transplant recipients.(4 weeks after second dose of vaccine)
- Humoral immunogenicity to varicella zoster induced by varicella zoster subunit vaccine in post-transplant group vs. pre-transplant group(4 weeks after second dose of vaccine)
研究者
Deepali Kumar
MD
University Health Network, Toronto