Comparison of Immune Response to Booster Vaccines in Blood Transplant Patients and Healthy Volunteers
Comparison of Immune Response to Booster Vaccines in Blood Transplant Patients and Healthy Volunteers
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.
HEALTHY VOLUNTEERS:

 Male or female subjects who are at least 18 years of age, but no older than 60 years of
 age.

 Received complete hepatitis B and/or tetanus/diphtheria vaccination series.

 If female, have a negative urine or serum pregnancy test within two weeks prior to entry
 into this study, and agree to avoid pregnancy during entire participation through the use
 of effective birth control or abstinence.

 Volunteers reporting good general health and denying any illness that can adversely affect
 an immune response to a vaccine.

 No history of a serious adverse event associated with any previous vaccination.

 Not participating in another experimental vaccine study.

 Serum hemoglobin greater than or equal to 11 g/dL.

 No history of hepatitis B.

 Must not have received a tetanus/diphtheria or hepatitis B booster in the last 6 months.

 HSCT VOLUNTEERS:

 Male or female subjects who are at least 5 years of age, but no older than 60 years of age.

 Be enrolled in a HSCT protocol at NIH.

 Be greater than or equal to 3 months post-HSCT.

 Received tetanus/diphtheria vaccination series.

 If female, have a negative urine or serum pregnancy test within two weeks prior to entry
 into this study, and agree to avoid pregnancy during entire participation through the use
 of effective birth control or abstinence.

 No history of a serious adverse event associated with any previous vaccination.

 Not participating in another experimental vaccine study.

 Serum hemoglobin greater than or equal to 9 g/dL.

 No history of hepatitis B.

 Not receiving any more than replacement glucocorticoid therapy.

 Not receiving any dose of cyclosporine.

 No acute graft-versus-host disease grade II or higher, at time of consideration for study.

 No chronic graft-versus-host disease more involved than localized skin lesions and/or liver
 dysfunction, at time of consideration for study.

 Must not have received a tetanus/diphtheria or hepatitis B booster in the last 6 months.