Exploration of Immune Response to Pneumococcal Conjugate Vaccine (PCV13) Administered Before and Early After Autologous Peripheral Stem Cell Transplant (Auto-PSCT) in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of Participants With Immune Response
研究概览
简要总结
There is no study hypothesis. The purpose of this study is to see if the Pneumococcal conjugate vaccine (PCV13), when administered before and early after an autologous peripheral stem cell transplant will induce an immune response.
详细描述
This is a pilot study to determine the safety of PCV13 administered to patients with myeloma before and at +7-10 days and +21-24 days after autologous hematopoietic stem cell transplant; and,to quantify the immune response induced by PCV13 vaccination in patients with myeloma when administered before and early after autologous PSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients with confirmed multiple myeloma
- •Eligible for treatment with high dose melphalan based regimen and autologous peripheral stem cell transplant
排除标准
- •Pregnant or lactating woman, as evaluated by serum testing within 24 hours of administration of the first vaccine
- •HIV infection confirmed by nucleic acid testing (NAT), as evaluated during pre transplant testing
- •Common variable immunodeficiency or other inherited systemic immunodeficiency syndrome
- •Active central nervous system (CNS) malignancy
- •Prior malignancy within 5 years of enrollment excluding non-melanoma skin cancer or cervical carcinoma after curative resection, not requiring chemotherapy.
- •History of severe allergy (e.g., anaphylaxis) to any component of pneumococcal conjugate vaccine 7 (PCV7), PCV13, or any diphtheria-toxoid containing vaccine.
- •Inclusion on a separate trial in which patients may be randomized or otherwise started on maintenance chemotherapies within the first 3 months of autologous transplantation
- •Patients with significant psychiatric illness likely to affect compliance, as determined by the treating physician
- •Active or uncontrolled infection
- •Diffusing lung capacity oxygenation (DLCO) <50 %
- •Left ventricular ejection fraction (LVEF) <40%
- •Bilirubin >2
结局指标
主要结局
Number of Participants With Immune Response
时间窗: 30 Days Post Vaccine
Positive response per test category. Post-vaccination result higher than pre-vaccination values for each test category criteria. Additional details are reported under Secondary Outcome Measures.
次要结局
- CD4+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)(30 Days Post Vaccine)
- CD8+CTV-IFN-gamma+, Best Response Against Vaccine (CRM 197)(30 Days Post Vaccine)
- CD8+CD107a+, Best Response Against Vaccine (CRM 197)(30 Days Post Vaccine)