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Patient-donor Vaccination in Allogeneic BMT with Post-Transplant Cyclophosphamide
NCT01282216Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2011
- Primary completion
- Jan 2016
- Countries
- 1
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center
- Modality
- Whole Inactivated Vaccines
- Conditions
- pneumococcal infectionhepatitis A (HAV)
01
Overview
Phase 2, randomised, open-label trial in pneumococcal infection and hepatitis A (HAV) comparing Donor PCV13 with Donor Havrix (2 arms). Primary endpoint: T-cell Immunity Augmentation at 6 months. Started Apr 2011; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Donor PCV13
Donors receive PCV13. Recipients receive PCV13 and Havrix post-transplant.
Donor Havrix
Donors receive Havrix. Recipients receive PCV13 and Havrix post-transplant.
03
Endpoints
Primary
T-cell Immunity Augmentation
Secondary
Recipient Vaccine-specific T-cell Response Post-transplant, Before Vaccination
Recipient Vaccine-specific T-cell Response After Post-transplantation Vaccine
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