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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: Completed Phase 1 study of Cytomegalovirus Infection, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00373412 record still lists
NCT00373412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 241-participant average among 5 other Cytomegalovirus Infection trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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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