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NCT01195571 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
A Phase 1 study of Cytomegalovirus, sponsored by CMV Research Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01195571: Completed Phase 1 study of Cytomegalovirus, sponsored by CMV Research Foundation.
NCT01195571 is a Phase 1 study of Cytomegalovirus that has completed, run by CMV Research Foundation. The registered enrollment target is 36 participants, below the 215-participant average among 5 other Cytomegalovirus trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01195571, a Phase 1 study of Cytomegalovirus, has completed, sponsored by CMV Research Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to test the safety and tolerability of four new investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the United States by the age of twenty-one. CMV does not usually cause illness in adults or children. However, CMV can be a cause of deafness and mental retardation in a child if a mother is infected during pregnancy. It also can be a serious illness in patients with impaired immunity (decreased ability to fight infection).
Primary Outcome
To evaluate the safety and tolerability, in adults without prior HCMV immunity (seronegative), of four live attenuated HCMV investigational vaccines at each of three dose levels.
Conditions Studied
Interventions
- BIOLOGICAL cmv vaccine
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
What the finished NCT01195571 record still lists
NCT01195571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 215-participant average among 5 other Cytomegalovirus trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Cytomegalovirus appearing as the primary indexed condition, and to 1 intervention - of which cmv vaccine is the first listed.
NCT01195571 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01195571 about?
NCT01195571 is a clinical study titled "Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age". The purpose of this research study is to test the safety and tolerability of four new investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male volunteers who are CMV negative. CMV is a common virus, infecting 50-80% of adults in the United States by the age of twenty-...
What is the current status of trial NCT01195571?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-09. Estimated completion is 2014-10.
What conditions does trial NCT01195571 study?
This clinical trial studies the following conditions: Cytomegalovirus.
What interventions are being tested in trial NCT01195571?
The interventions under investigation include: cmv vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01195571?
This trial is sponsored by CMV Research Foundation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01195571 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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