drugset / Trial / NCT02700841
Enhancing Anti--Tetanus Vaccine Response After Autologous Stem Cell Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
This pilot randomized Phase II trial (10 subjects per arm) will compare immune reconstitution following transplantation of an autologous mobilized graft product to reconstitution following transplantation of a mobilized graft product followed by an autologous lymphocyte infusion collected prior to G-CSF mobilization. All subjects will receive tetanus vaccines pre and post-transplant. The primary end point will be tetanus vaccine immune responses post-transplant.
Timeline
- Start
- 2020-01-09
- Primary completion
- 2022-12-21
- Completion
- 2022-12-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tetanus toxoid vaccine | Vaccine | — | Intramuscular |
| Background | Melphalan | Small molecule | — | Intravenous |