Safety and Immunogenicity of Non-live, Recombinant Subunit Herpes Zoster Vaccine in VZV-seronegative Solid Organ Transplant Recipients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
研究概览
简要总结
The investigators plan to study the immunogenicity of the vaccine in VZV-seronegative solid organ transplant recipients. VZV-seronegative patients will be enrolled after organ transplantation. The investigators hypothesize that the recombinant subunit Herpes zoster vaccine is able to induce cellular immunogenicity after transplantation in VZV-seronegative patients.
详细描述
Solid organ transplant recipients receive lifelong immunosuppression and are at increased risk for severe primary VZV infection (chickenpox) and VZV reactivation (shingles). A non-live, recombinant subunit Herpes zoster vaccine (Shingrix; GSK vaccines) was recently licensed for the prevention of shingles in people aged 50 years or older and was shown to induce both cellular and humoral immunity. As both components of the immune system are important for protection against VZV, the investigators plan to study the humoral and cellular immunogenicity of the vaccine after organ transplantation in VZV-seronegative patients. Indeed, the current live VZV vaccine is contraindicated after transplantation; therefore, the non-live recombinant varicella-zoster subunit vaccine, if shown to induce cellular and humoral immunity, could potentially be offered to VZV-seronegative transplant patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Solid organ transplant recipient.
- •Age ≥18 years
- •VZV-seronegative at time of transplant
- •≥90 days post-transplant
- •Able to provide informed consent
排除标准
- •Has already received the recombinant subunit Herpes zoster vaccine in the past
- •Ongoing CMV viremia > 200 IU/mL
- •HIV infection
- •Diagnosis of malignancy (e.g. PTLD)
- •History of a severe allergic reaction (anaphylactic reaction) after any vaccine
- •Documented Chickenpox or Shingles after transplantation
- •Congenital immunodeficiency (e.g., CVID)
- •Treatment for rejection in the past 30 days
- •Immunoglobulin in the past 30 days or anticipated to receive immunoglobulin
- •Anti-CD20 monoclonal antibody in the past 6 months or anticipated to receive Anti-CD20 monoclonal antibody
- •Plasmapheresis in the past 30 days or anticipated to receive plasmapheresis
- •Febrile illness in the past one week
- •Unable to comply with the study protocol
结局指标
主要结局
Humoral immunity to varicella zoster induced by the recombinant subunit Herpes zoster vaccine.
时间窗: 4 weeks after second dose of vaccine
Fold increase in concentration of anti-gE antibody titer from pre- to post-vaccination
次要结局
- Rate of Vaccine-related Adverse Events(Up to 4 weeks after second dose of vaccine)
研究者
Deepali Kumar
Principal Investigator
University Health Network, Toronto