Seasonal Influenza Vaccine High Dose Boosting in Solid Organ Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Neutralizing antibody levels- Immunogenicity
研究概览
简要总结
In solid organ transplant (SOT) the receipt of influenza vaccine in an influenza season is associated with decreased disease severity as demonstrated by the presence of pneumonia and ICU admissions. Different strategies have been assessed to optimize vaccine efficacy and immunogenicity of the influenza vaccine in the solid organ transplant recipient (SOTR). The primary objective of the study is to evaluate the immunogenicity of 2 doses of the high dose influenza vaccine utilizing neutralizing antibody assays. A control group receiving 1 HD influenza vaccine will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •>=18 years old who underwent a solid organ transplant (Liver, lung, heart, kidney, pancreas) > 1 year prior to enrollment
- •At least 1-year post-transplant
- •Able and willing to provide informed consent
- •Able and willing to undergo all study activities throughout the duration of the study
排除标准
- •Confirmed pregnancy
- •Receipt of ATG or carfilzomib within the past 3 months
- •Receipt of rituximab within the past 3 months
- •Receipt of basiliximab within the past 3 months
- •Prednisone dose >= 20 mg/day at the time of enrollment
- •History of a severe allergy to influenza vaccine (i.e. Guillain Barre syndrome, anaphylaxis or angioedema)
研究组 & 干预措施
booster group
Participants who have undergone a solid organ transplant will receive two doses of an inactivated high dose influenza vaccine
干预措施: Fluzone High-Dose - 2 doses (Drug)
Control group
Participants who have undergone a solid organ transplant will receive one dose of inactivated high dose influenza vaccine followed by a placebo injection
干预措施: Fluzone High-Dose - 1 dose of HD (Drug)
结局指标
主要结局
Neutralizing antibody levels- Immunogenicity
时间窗: 3 months after 2nd dose
Geometric mean titers and geometric mean fold rise from baseline of homologue neutralizing antibodies in reporter microneutralization will be measured and compared across groups.
次要结局
- clinical - death rates(2 years)
- clinical outcome- pneumonia(2 years)
- clinical outcome- hospitalization rates(2 years)
- clinical outcome- ICU admissions(2 years)