Immune Response to Cytomegalovirus
Primary Purpose
Cytomegalovirus Infections
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cytomegalovirus Infections focused on measuring Normal Volunteer, Phlebotomy, Cytomegalovirus, CMV, CMV Seropositve
Eligibility Criteria
INCLUSION CRITERIA: Age 18-65 CMV seropositive Informed consent given EXCLUSION CRITERIA: CMV seronegative Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul) Known history of heart, lung, kidney, liver, or bleeding disorder Diagnosis of HIV infection Diagnosis or suspicion of immunodeficiency state History of intravenous drug use Currently pregnant
Sites / Locations
- National Heart, Lung and Blood Institute (NHLBI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00034437
First Posted
April 27, 2002
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00034437
Brief Title
Immune Response to Cytomegalovirus
Official Title
Measurement of Cytomegalovirus (CMV)-Specific T Lymphocytes in CMV-Seropositive Normal Volunteers.
Study Type
Observational
2. Study Status
Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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.
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 and/or 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infections
Keywords
Normal Volunteer, Phlebotomy, Cytomegalovirus, CMV, CMV Seropositve
7. Study Design
Enrollment
20 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Age 18-65
CMV seropositive
Informed consent given
EXCLUSION CRITERIA:
CMV seronegative
Abnormal blood counts (hemoglobin less than 12 g/dl, platelets less than 150,000/ul, absolute neutrophil count less than 1,500/ul, absolute lymphocyte count less than 1,000/ul)
Known history of heart, lung, kidney, liver, or bleeding disorder
Diagnosis of HIV infection
Diagnosis or suspicion of immunodeficiency state
History of intravenous drug use
Currently pregnant
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
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Immune Response to Cytomegalovirus
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