NCT00034437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2002

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2002

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2003

First QC Date

April 27, 2002

Last Update Submit

March 3, 2008

Conditions

Keywords

Normal VolunteerPhlebotomyCytomegalovirusCMVCMV Seropositve

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • CMV seropositive
  • Informed consent given

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 27, 2002

First Posted

April 29, 2002

Study Start

April 1, 2002

Study Completion

April 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-04

Locations