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NCT00373412 · ClinicalTrials.gov registry record · Phase 1
Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
A Phase 1 study of Cytomegalovirus Infection, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT00373412 is a Phase 1 study of Cytomegalovirus Infection that has completed, run by University of California, San Francisco. The registered enrollment target is 16 participants, below the 241-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00373412, a Phase 1 study of Cytomegalovirus Infection, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Objectives of this trial are to: Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg weekly x 3) 3 months previously compared to randomized controls who do not receive VCL CT02 as measured by: 1. antibody titers for gB; 2. T-cell IFN-g ELISPOT; 3. T-cell proliferation assays for IE1, pp65, and/or gB; and 4. cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB. Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02) administered intramuscularly. Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02 priming will be greater than that after Towne vaccination alone.
Conditions Studied
Interventions
- BIOLOGICAL VCL CT02 pDNA vaccine
- BIOLOGICAL Towne CMV vaccine
Study Locations (1)
California
- UCSF Positive Health Program, 995 Potrero, 4th Floor - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2006-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00373412
The ClinicalTrials.gov registry entry for NCT00373412 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 241-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (93% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cytomegalovirus Infection appearing as the primary indexed condition, and to 2 interventions - of which VCL CT02 pDNA vaccine is the first listed.
NCT00373412 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT00373412 about?
NCT00373412 is a clinical study titled "Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge". Objectives of this trial are to: Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg weekly x 3) 3 months previously compared to randomized controls who do not receive ...
What is the current status of trial NCT00373412?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-10.
What conditions does trial NCT00373412 study?
This clinical trial studies the following conditions: Cytomegalovirus Infection.
What interventions are being tested in trial NCT00373412?
The interventions under investigation include: VCL CT02 pDNA vaccine (BIOLOGICAL), Towne CMV vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00373412?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00373412 being conducted?
This trial has 1 study location across California. 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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