Donor-Derived Humoral Immunity, Hematopoietic Stem Cell Transplantation, TAR
Condition: Acute Lymphoblastic Leukemia; Acute Myelogenous Leukemia; Chronic Myelogenous Leukemia; Myelodysplastic Syndrome; Hodgkin Lymphoma; Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional

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.
    

Intervention name(s): Tetanus
Intervention type(s): Biological
Intervention description(s): 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.
Other intervention name(s): Tetanus Toxoid vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
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