Healthy Clinical Trial
Official title:
Evaluation of Hepatitis B Surface Antigen-Specific and Tetanus Toxoid-Specific Lymphocytes
This study will compare the immune system response to booster vaccines for
tetanus/diphtheria and hepatitis B in healthy volunteers with that of patients who have had
a blood transplant. (A blood transplant is an infusion of donated stem cells-i.e., cells
that mature into white blood cells, red blood cells and platelets). The study will also look
at how age of the blood cell donor and recipient, the type of blood transplant, the amount
of certain types of white cells in donor blood, and other variables may influence the
vaccine response among the transplant patients.
This study includes normal volunteers and patients who have had a blood transplant. Healthy
volunteers between the ages of 18 and 60 who have previously been vaccinated with the
hepatitis B or tetanus/diphtheria vaccine and have not had hepatitis B may be eligible for
this study. Patients enrolled in a blood cell transplant study at NIH who are between 5 and
60 years old, have been vaccinated against tetanus/diphtheria, and have not had hepatitis B
may be eligible. Candidates will be screened with a medical history and blood tests.
Those enrolled in the study will have about 2 tablespoons of blood drawn before vaccination
with a standard tetanus/diphtheria booster shot. Volunteers who have previously been
vaccinated with the hepatitis B vaccine and all blood transplant patients will also receive
a hepatitis B vaccination. Participants will have blood drawn (from 1 to 5 tablespoons) up
to once a week after vaccination for no more than 8 weeks to evaluate the immune response to
vaccination.
This study will compare booster vaccine responses in patients undergoing hematopoietic stem cell transplant (HSCT) to a group of healthy volunteers. Responses among different types of HSCT will be compared to each other as well. Serum antibody titers to vaccine antigens and quantification of antigen specific lymphocytes will be followed. Approximately 15 healthy subjects and 40 patients will be enrolled. ;
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