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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• Baylor College of Medicine

  collaborator OTHER

• The Methodist Hospital Research Institute

  collaborator OTHER

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• Robert Krance

  lead OTHER

Principal Investigators

• Robert Krance, MD · Texas Childrens Hospital / Baylor College of Medicine

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2012-11-30

Completion

2013-07-31

Countries

• United States

Study Locations