Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Vaccine response
研究概览
简要总结
This study aims to use two different blood tests (ELISA and OPA) to study response to pneumococcal vaccination administered as per standard guidelines in patients who are undergoing workup for heart transplant (whether or not they have undergone LVAD implantation or have undergone heart transplant.
详细描述
The patients will be receiving vaccination consistent with standard of care guidelines, regardless of study participation. The additional risk of study participation would be the risks associated with venipuncture (injury to vessel or nerve, syncope).
Patients will not accrue benefits personally. However, participation will help others by identifying whether current vaccination strategies in this population are adequate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 or over
- •Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant
- •Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines
排除标准
- •Infants and children under age 18
- •Subjects without the capacity to consent
- •Pregnancy
- •Already up to date on pneumococcal vaccination or declining vaccination
研究组 & 干预措施
PPS23 only
Draw blood for ELISA and OPA, then administer PPS23
PCV15 and PPS23
Draw blood for Administer PPS23 then draw blood again ELISA and OPA, then administer PCV15
干预措施: PCV15 (Biological)
PCV15 only
Draw blood for ELISA and OPA, then administer PCV15
干预措施: PCV15 (Biological)
结局指标
主要结局
Vaccine response
时间窗: 12 weeks
Antibody levels
次要结局
- Serotype ELISA response(12 weeks)