Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005907
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-06-09
Brief Title:
Comparison of Immune Response to Booster Vaccines in Blood Transplant Patients and Healthy Volunteers
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of Hepatitis B Surface Antigen-Specific and Tetanus Toxoid-Specific Lymphocytes
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the immune system response to booster vaccines for tetanusdiphtheria 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-ie 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 tetanusdiphtheria 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 tetanusdiphtheria 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 tetanusdiphtheria 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 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 tetanusdiphtheria 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 tetanusdiphtheria 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 tetanusdiphtheria 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-I-0144 | None | None | None |