Clinical trial · Interventional
Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research study is for subjects that are receiving a bone marrow transplant. As part of the transplant subjects will receive stem cells from a donor who has agreed to donate stem cells for them. Unfortunately, it takes a long time for the immune system to recover after a bone marrow transplant. This makes it more likely for patients to develop serious infections. This study is being done to better understand how the immune system will recover after transplant. The immune system includes the cells that help fight infection. This study will help investigators understand which patients are at risk for developing infections after transplant. All children and adults receive standard vaccines (shots) during their lifetime to provide protection from many different infections. One such infection is tetanus, a bacteria that can cause life-threatening problems. After transplant patients no longer have protection from infections such as tetanus. Therefore, most patients need to receive all their vaccine (shots) again after transplant. This is usually done 1-2 years after transplant, since it may take that long for patients to have a normal immune system. However, the investigators believe that the time it will take for the patient to develop normal protection against tetanus can be shortened if both the patient and the patient's stem cell donor receive a tetanus vaccine. The goal of this study is to determine if giving a tetanus vaccine to the donor and the patient will provide the patient with enough protection (immunity) to prevent infection following bone marrow transplant.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tetanus | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm: Tetanus Toxoid
- description
- SCT Donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest
- interventionNames
- Biological: Tetanus
Primary outcomes (1)
- measure
- Antibody Recall Response Rate
- timeFrame
- 4 months
- description
- The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
Secondary outcomes (1)
- measure
- Change in Immunoglobulin Levels
- timeFrame
- up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 70 Years
Show eligibility criteria text
INCLUSION CRITERIA: Inclusion Criteria for Donors: * Related donor of bone marrow or peripheral blood stem cell product * Age 3 to 70 years * Informed consent form signed and sent to Research Coordinator Inclusion Criteria for Recipients: * Patient with acute lymphoblastic leukemia, acute myelogenous leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, myeloproliferative disorder, Hodgkin lymphoma, non-Hodgkin lymphoma, or a non-malignant disease requiring allogeneic stem cell transplant * Age between 3 and 70 years * Informed consent form signed and sent to Research Coordinator EXCLUSION CRITERIA: Exclusion Criteria for Donors: * Allergy to tetanus vaccine * Pregnant or lactating * Has received tetanus booster within preceding 12 months Exclusion Criteria for Recipients to Receive FIRST Tetanus Immunization: * Allergy to tetanus vaccine * Has received tetanus booster within preceding 12 months * Has active malignancy (not in remission) Exclusion Criteria for Recipients to Receive SUBSEQUENT Tetanus Immunization: * Allergy to tetanus vaccine * Active, acute graft vs. host disease (GVHD) greater than or equal to grade II or chronic graft vs. host disease (GVHD) * Disease relapse - less than 75% donor chimerism (peripheral blood or bone marrow) * Active infection (bacterial, viral, fungal) or fever (temperature greater than 100.5 celsius)
References
Publications (0)
Data not yet available