An interventional study of Tetanus in Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia and Chronic Myelogenous Leukemia, sponsored by Robert Krance. Completed at 2 sites in United States. Open to participants aged 3 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Robert Krance · Not applicable, Interventional, and Prevention
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 7 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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INCLUSION CRITERIA:
Inclusion Criteria for Donors:
Inclusion Criteria for Recipients:
EXCLUSION CRITERIA:
Exclusion Criteria for Donors:
Exclusion Criteria for Recipients to Receive FIRST Tetanus Immunization:
Exclusion Criteria for Recipients to Receive SUBSEQUENT Tetanus Immunization:
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
Biological: 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.
Also known as: Tetanus Toxoid vaccine
Antibody Recall Response Rate
The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
Time frame: 4 months
Change in Immunoglobulin Levels
Changes from baseline to several time points during follow-up will be calculated.
Time frame: up to 12 months
| Milestone | Single Arm: Tetanus Toxoid |
|---|---|
| Started | 7 |
| Completed | 5 |
| Not completed | 2 |
| Withdrew: Relapsed | 2 |
The proportion of participants with antibody recall response along with 95% confidence intervals will be calculated.
| proportion of participants | Single Arm: Tetanus Toxoid |
|---|---|
| Antibody Recall Response Rate | 0.167 (0.004 to 0.641) |
Changes from baseline to several time points during follow-up will be calculated.
| MG/DL | Single Arm: Tetanus Toxoid |
|---|---|
| IgA Change at 3 months | -49.9 (-68.0 to -31.0) |
| IgA Change at 6 months | -1.0 (-29.0 to 66.0) |
| IgA Change at 12 months | 7.7 (-34.0 to 16.0) |
| IgG Change at 3 months | -677.6 (-717.0 to -676.1) |
| IgG Change at 6 months | -668.2 (-678.0 to -369.0) |
| IgG Change at 12 months | -683.0 (-1182.0 to -659.5) |
| IgM Change at 3 months | 13.7 (11.9 to 30.5) |
| IgM Change at 6 months | 45.0 (21.6 to 148.0) |
| IgM Change at 12 months | 75.8 (40.0 to 98.0) |
Collected over Toxicities will be assessed while patients are receiving tetanus toxoid and for 6 weeks following last vaccination, either 6 weeks after the first booster or 6 weeks after the second booster, if the patient receives the second booster.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm: Tetanus Toxoid | 0/7 (0%) | 2/7 (28.6%) | 7/7 (100%) |
| Event | Single Arm: Tetanus Toxoid |
|---|---|
| DiarrheaGastrointestinal disorders | 1/7 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/7 |
| Infection - Other: Gastrointestinal AbdomenInfections and infestations | 1/7 |
| VomitingGastrointestinal disorders | 1/7 |
| Event | Single Arm: Tetanus Toxoid |
|---|---|
| Albumin, serum-low (hypoalbuminemia)Metabolism and nutrition disorders | 7/7 |
| Sodium, serum-low (hyponatremia)Metabolism and nutrition disorders | 7/7 |
| AST, SGOT(serum glutamic oxaloacetic transaminase)Investigations | 6/7 |
| Calcium, serum-low (hypocalcemia)Metabolism and nutrition disorders | 5/7 |
| Magnesium, serum-low (hypomagnesemia)Metabolism and nutrition disorders | 5/7 |
| Bicarbonate, serum-lowMetabolism and nutrition disorders | 4/7 |
| NauseaGastrointestinal disorders | 4/7 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 4/7 |
| VomitingGastrointestinal disorders | 4/7 |
| ALT, SGPT (serum glutamic pyruvic transaminase)Investigations | 3/7 |
| Age, Continuous(years) | Single Arm: Tetanus Toxoid |
|---|---|
| Median | 7 (3 to 18) |
| Sex: Female, Male(Participants) | Single Arm: Tetanus Toxoid |
|---|---|
| Female | 2 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Single Arm: Tetanus Toxoid |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 2 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Single Arm: Tetanus Toxoid |
|---|---|
| Black | 1 |
| White | 6 |
| Region of Enrollment(participants) | Single Arm: Tetanus Toxoid |
|---|---|
| United States | 7 |
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