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NCT00353977 · ClinicalTrials.gov registry record · Phase 2
Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors
A Phase 2 study of Cytomegalovirus Infections, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT00353977 is a Phase 2 study of Cytomegalovirus Infections that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 38 participants, below the 201-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00353977, a Phase 2 study of Cytomegalovirus Infections, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a member of the herpesvirus group, which includes herpes simplex virus types 1 and 2, varicella-zoster virus (which causes chickenpox), and Epstein-Barr virus (which causes infectious mononucleosis). Most adults are infected with CMV, but a healthy immune system keeps the virus in check, so that it does not cause harm. In people with a weakened immune system, such as transplant recipients, the virus can become reactivated. Medications for treating the infection may cause low blood counts and kidney damage, and, in some cases, the virus may cause death. The ALVAC-pp65 vaccine is intended to improve immunity against CMV in stem cell donors and thereby prevent its reactivation in recipients. It is made from a virus that ordinarily infects canaries. The virus is weakened so that it cannot infect the person who receives it, and it is modified to carry a copy of a CMV gene called pp65. This gene instructs cells to make CMV proteins that the vaccine recipient's immune system can produce antibodies to, thus conferring immunity to the disease. Persons 18 years of age or older who are scheduled to donate stem cells for a patient in an NIH protocol and who are not allergic to eggs, egg products, or other vaccines, may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood tests. Participants receive three vaccinations one week apart beginning at least 3 weeks before the scheduled stem cell donation. They are observed for 30 minutes after each vaccination to look for any immediate side effects of the vaccine. Approximately 3 tablespoons of blood are drawn before each vaccination and 1 week after the last vaccination to evaluate vaccine safety. Blood samples are also collected at the screening evaluation, 3 weeks after the start of vaccination, and
Conditions Studied
Interventions
- BIOLOGICAL ALVAC-CMV (vCP260)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-05 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00353977
The ClinicalTrials.gov registry entry for NCT00353977 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 201-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (81% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 1 intervention - of which ALVAC-CMV (vCP260) is the first listed.
NCT00353977 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00353977 about?
NCT00353977 is a clinical study titled "Accelerated Immunization to Induce Cytomegalovirus Immunity in Stem Cell Donors". This study will evaluate the safety and effectiveness of a new vaccine, ALVAC-pp65, in boosting immunity to cytomegalovirus (CMV) infection in stem cell transplant donors. CMV is a member of the herpesvirus group, which includes herpes simplex virus types 1 and 2, varicella-zoster virus (which cause...
What is the current status of trial NCT00353977?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2004-05. Estimated completion is 2008-03.
What conditions does trial NCT00353977 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections.
What interventions are being tested in trial NCT00353977?
The interventions under investigation include: ALVAC-CMV (vCP260) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00353977?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00353977 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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