Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge

Completed · Phase 1

Conditions studied: Cytomegalovirus Infection

In brief

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.

Key facts

Study ID

NCT00373412

Run by

University of California, San Francisco

People needed

16

Starts

2006-10-01

Last updated by the study team

2008-05-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 45 years of age
• Normal lab values at study entry
• Good general health
• Negative CMV IgG antibody test

You may not qualify if…

• CMV seropositive
• Recent vaccination(s)
• Immunodeficiency
• Vaccination with investigational CMV vaccine(s)
• Pregnant or breast-feeding

Where it is running

• UCSF Positive Health Program, 995 Potrero, 4th Floor — San Francisco, California, United States

Full record on ClinicalTrials.gov

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