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

Healthy Clinical Trial

Official title:
Evaluation of Hepatitis B Surface Antigen-Specific and Tetanus Toxoid-Specific Lymphocytes

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00005907
Study type Observational
Source National Institutes of Health Clinical Center (CC)
Contact
Status Completed
Phase N/A
Start date June 2000
Completion date May 2002
View Details
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