Transfer of Donor-Derived Humoral Immunity Following Allogeneic Hematopoietic Stem Cell Transplantation
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.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of patients with antibody recall response at 4 months after Stem cell transplant
To determine antibody recall responses in patients receiving allogeneic hematopoietic stem cell transplants
Catherine Bollard, MD
Baylor College of Medicine
United States: Institutional Review Board
|The Methodist Hospital||Houston, Texas 77030|
|Texas Childen's Hospital||Houston, Texas 77030|