Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034437
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-04-27
Brief Title:
Immune Response to Cytomegalovirus
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Measurement of Cytomegalovirus CMV-Specific T Lymphocytes in CMV-Seropositive Normal Volunteers
Status:
COMPLETED
Status Verified Date:
2003-04
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 evaluate immune responses against cytomegalovirus CMV About 80 percent of adults have been exposed to this virus CMV typically remains dormant inactive in the body causing no problems In people with immune suppression however the virus can become reactivated and cause life-threatening pneumonia The knowledge gained from this study may be useful in developing ways to improve immune responses to CMV in stem cell transplant recipients
Healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study Candidates will be screened with a medical history and blood tests Those enrolled will provide a 30-milliliter 6-tablespoon blood sample once a week for 4 weeks and a final sample 2 months later The blood will be used to design a test to detect immune responses against CMV and determine the differences in these responses among healthy individuals
Healthy normal volunteers between 18 and 65 years of age who have been exposed to cytomegalovirus are eligible for this study Candidates will be screened with a medical history and blood tests Those enrolled will provide a 30-milliliter 6-tablespoon blood sample once a week for 4 weeks and a final sample 2 months later The blood will be used to design a test to detect immune responses against CMV and determine the differences in these responses among healthy individuals
Detailed Description:
The NHLBI Stem Cell Allotransplantation Program is researching methods to improve immunity against infectious organisms following allogeneic stem cell transplantation SCT We are particularly interested in cytomegalovirus CMV which can cause serious problems in patients following transplantation In the future we hope to design ways to improve immune responses to CMV in transplant recipients such as vaccinating transplant donors andor patients against this virus In order to characterize the effect of any such intervention on CMV immunity we first need to better understand CMV immune responses in normal healthy persons This involves designing and validating an in vitro assay which can reliably and consistently detect immune responses against CMV Furthermore we hope to define the temporal variability that exists in CMV responses in healthy individuals which is essential for the design and implementation of all future studies We plan to collect blood samples from 20 normal volunteers who have been previously exposed to CMV CMV seropositive individuals Eligible individuals will be asked to donate blood on five occasions once a week for four weeks and a fifth time two months later Eligible individuals must be 18-65 years of age otherwise healthy and seropositive for CMV exposure
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 |
|---|---|---|---|
| 02-H-0189 | None | None | None |