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Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
NCT00373412 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francis, which has 1,574 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00373412 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00373412?
The interventions under investigation include: VCL CT02 pDNA vaccine (BIOLOGICAL), Towne CMV vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00373412?
This trial is sponsored by University of California, San Francis, which has 1,574 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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