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Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR

Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01611298
Acronym
TAR
Enrollment
7
Registered
2012-06-04
Start date
2008-03-31
Completion date
2013-07-31
Last updated
2020-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Hodgkin Lymphoma, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma

Keywords

allogeneic stem cell transplant, malignant diseases, Acute lymphoblastic leukemia, acute myelogenous leukemia, Chronic myelogenous leukemia, myelodysplastic syndrome, Hodgkin lymphoma, non-Hodgkin lymphoma, myeloproliferative disorder, non-malignant disease

Brief summary

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.

Detailed description

To participate in this study, patients will need to have given informed consent to have a bone marrow transplant. Before receiving the tetanus vaccine, we would like to test the patient's immune system against tetanus. We will again want to test the patient's immune system against tetanus on the day the patient receives the bone marrow transplant. Approximately 3 months after transplant, if the patient is still eligible, they will receive an additional tetanus booster shot. We will again draw blood to test their immune system against tetanus at the time points listed below. TREATMENT PLAN: If the subject meets eligibility requirements and consents to be part of this study, we will collect 8 mL (1.7 teaspoons) of blood from the subject to test their immunity 7 to 10 days before their bone marrow transplant. The subject will receive a tetanus vaccine (given as an injection into the upper arm or thigh muscle) on that same day. We will then collect approximately the same amount of blood (2 teaspoons) on the day the patient would receive the bone marrow transplant. We will also collect the same amount of blood 1 week, 2 weeks, 4 weeks and 3 months, 6 months and 12 months after the transplant. This will help us to see how the patients immune system responded to the vaccine. Three months after the transplant, the patient will receive an additional tetanus vaccine (known as a booster shot), but only if the patient is still eligible to receive it. Patient's will only be eligible to receive the booster shot if they remain well and do not have any other problems such as severe infection, graft versus host disease or relapse. We will collect 8 ml (1.7 teaspoons) of blood 1 week, 2 weeks and 4 weeks after receiving the booster shot to determine if they respond to the vaccine.

Interventions

BIOLOGICALTetanus

Stem cell transplant 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. Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose). Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.

Sponsors

Baylor College of Medicine
CollaboratorOTHER
The Methodist Hospital Research Institute
CollaboratorOTHER
Center for Cell and Gene Therapy, Baylor College of Medicine
CollaboratorOTHER
Robert Krance
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Antibody Recall Response Rate4 monthsThe proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.

Secondary

MeasureTime frameDescription
Change in Immunoglobulin Levelsup to 12 monthsChanges from baseline to several time points during follow-up will be calculated.

Countries

United States

Participant flow

Participants by arm

ArmCount
Single Arm: Tetanus Toxoid
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 Tetanus: Stem cell transplant 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. Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose). Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection.
7
Total7

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyRelapsed2

Baseline characteristics

CharacteristicSingle Arm: Tetanus Toxoid
Age, Continuous7 years
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race/Ethnicity, Customized
Black
1 Participants
Race/Ethnicity, Customized
White
6 Participants
Region of Enrollment
United States
7 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 7
other
Total, other adverse events
7 / 7
serious
Total, serious adverse events
2 / 7

Outcome results

Primary

Antibody Recall Response Rate

The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.

Time frame: 4 months

Population: One participant was off study on day 68 and not included in this analysis.

ArmMeasureValue (NUMBER)
Single Arm: Tetanus ToxoidAntibody Recall Response Rate0.167 proportion of participants
Secondary

Change in Immunoglobulin Levels

Changes from baseline to several time points during follow-up will be calculated.

Time frame: up to 12 months

Population: One participant was off study on day 68 and not included in this analysis. Six participants included in the analysis had at least one measurement at the follow-up time points. n=the number of participants with measurements for that time point.

ArmMeasureGroupValue (MEDIAN)
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgM Change at 12 months75.8 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgA Change at 3 months-49.9 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgA Change at 6 months-1.0 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgA Change at 12 months7.7 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgG Change at 3 months-677.6 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgG Change at 6 months-668.2 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgG Change at 12 months-683.0 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgM Change at 3 months13.7 MG/DL
Single Arm: Tetanus ToxoidChange in Immunoglobulin LevelsIgM Change at 6 months45.0 MG/DL

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026