Patient-donor Vaccination in the Context of Allogeneic Bone Marrow Transplant (BMT) With High-dose Post Transplantation Cyclophosphamide.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- T-cell Immunity Augmentation
研究概览
简要总结
This research is being done to understand the effects of certain types of bone marrow transplant (BMT) on the immune system. Your doctors are planning a BMT, using one of your family members as the bone marrow donor, for your cancer. Part of that BMT involves a chemotherapy drug, called Cyclophosphamide (Cytoxan), given after the transplant. This research is being done to understand the effects of Cyclophosphamide on the immune system.
详细描述
The research will involve giving your donor a vaccine against a certain infection, before the bone marrow donation: either a vaccine against hepatitis (the hepatitis A vaccine), or a vaccine against pneumonia (Prevnar). You will then get both of these vaccines following your transplant. By studying how much these vaccines may improve your immune system, we hope to better understand the effects of the BMT with Cyclophosphamide on the immune cells.
Prevnar is a pneumococcal vaccine (pneumococcus is a bacteria that can cause pneumonia and other infections). It is approved by the Food and Drug Administration (FDA) for the prevention of infections in children. It is not usually given to adults. Hepatitis A vaccine is approved by the FDA for the prevention of hepatitis A (a liver infection) in children and adults.
The vaccines are not approved for bone marrow donors or for vaccinating adults after BMT (using these vaccines in this research is investigational). The FDA is allowing the use of these vaccines in this research study.
Certain people getting BMT followed by Cyclophosphamide may join, if their donors might also join. Your bone marrow donor must take part in this study, in order for you to continue on this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Only the study pharmacist was unblinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients inclusion for study:
- •Patient age > 18 years.
- •Plan to undergo one of the following types of transplant, using bone marrow from a related donor:
- •Myeloablative, HLA matched or partially HLA-mismatched (haploidentical), related-donor bone marrow transplantation that includes high-dose posttransplantation Cy
- •Nonmyeloablative, HLA matched or partially HLA-mismatched, related-donor bone marrow transplantation that includes high-dose posttransplantation Cy Note: Patients who receive posttransplantation rituximab are eligible.
- •Patients inclusion for vaccine:
- •Receipt of the type of myeloablative or nonmyeloablative BMT
- •The bone marrow donor has received the pre-bone marrow harvest vaccine (either Prevnar or hepatitis A vaccine) on this study.
- •Donors inclusion:
- •Donor age > 18 years.
排除标准
- •Patients exclusion for study entry:
- •Hypersensitivity to either the components of hepatitis A vaccine (including neomycin) or the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).
- •Severe latex allergy.
- •Patients exclusion for vaccine:
- •Graft failure.
- •Disease progression or relapse, or disease persistence requiring treatment.Note: Patients with asymptomatic or low-volume disease progression or relapse may be eligible, determined on a case-by-case basis by the PI.
- •Systemic immunosuppression for GVHD treatment or prophylaxis within 4 weeks (+/- 5 days) prior to vaccination.
- •Pregnant or breastfeeding
- •Donors exclusion:
- •Hypersensitivity to both the components of hepatitis A vaccine (including neomycin) and the components of the PCV7 and PCV13 vaccines (including diphtheria toxin).
- •Severe latex allergy.
- •Expected to be on systemic immunosuppressants between the time of vaccination and the bone marrow donation.
- •Pregnant or breastfeeding
研究组 & 干预措施
Donor PCV13
Donors receive PCV13 prior to bone marrow donation.
干预措施: PCV13 (Biological)
Recipient vaccine
Recipients receive Havrix and PCV13 post bone marrow transplant.
干预措施: PCV13 (Biological)
Donor Havrix
Donors receive Havrix prior to bone marrow donation.
干预措施: Havrix (Biological)
Recipient vaccine
Recipients receive Havrix and PCV13 post bone marrow transplant.
干预措施: Havrix (Biological)
结局指标
主要结局
T-cell Immunity Augmentation
时间窗: up to 6 months
Number of participants in which patient-donor pairs were not pre-immune to hepatitis A or CRM197, show augmented T-cell immunity when the vaccine is also given to the bone marrow donor.
次要结局
- Recipient Vaccine-specific T-cell Response Post-transplant, Before Vaccination(up to 6 months)
- Recipient Vaccine-specific T-cell Response After Post-transplantation Vaccine(up to 6 months)