Comparison of Immune Response to Booster Vaccines in Blood Transplant Patients and Healthy Volunteers

Inclusion Criteria

• •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.