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

This study has been completed.
Information provided by:
University of California, San Francisco Identifier:
First received: September 6, 2006
Last updated: May 5, 2008
Last verified: October 2006

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.

Condition Intervention Phase
Cytomegalovirus Infection
Biological: VCL CT02 pDNA vaccine
Biological: Towne CMV vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized, Phase 1 Trial to Evaluate Safety and CMV-Specific Immune Response to a pDNA CMV Trivalent Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge in Healthy, CMV- Seronegative Adults

Resource links provided by NLM:

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • CMV-specific immune response post-Towne challenge: gB antibody, T-cell IFN-g ELISPOT, T-cell proliferation assays for IE1, pp65, and/or gB, cytokine and phenotypic flow cytometry responses to pp65, IE1, gB.

Secondary Outcome Measures:
  • Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).

Estimated Enrollment: 16
Study Start Date: October 2006
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

This is a Phase 1, single-center, randomized, open-label trial of the live, attenuated Towne CMV vaccine administered as a "challenge" to healthy, CMV-seronegative, adult subjects who previously receive the CMV immunotherapeutic trivalent pDNA-based vaccine, VCL-CT02, given by intramuscular route at Days 1, 7 and 14 or who receive no VCL-CT02.

Up to 12 healthy, CMV-seronegative subjects will be enrolled. If a subject consents and meets all eligibility criteria, the subject will be randomized to the VCL CT02 (N=6)or control (N=6) groups. VCL CT02-assigned subjects will receive VCL CT02 (1 mg weekly x 3) and then on Day 77 will received Towne vacine (3000 pfu subcutaneously). Control-assigned subjects will receive Towne alone. Safety will be monitored and both antibody to CMV gB and T-cell responses to CMV antigens will be measured at specified intervals for 252 days post Towne challenge.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • CMV seropositive
  • Recent vaccination(s)
  • Immunodeficiency
  • Vaccination with investigational CMV vaccine(s)
  • Pregnant or breast-feeding
  Contacts and Locations
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Please refer to this study by its identifier: NCT00373412

United States, California
UCSF Positive Health Program, 995 Potrero, 4th Floor
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Mark A Jacobson, MD University of California, San Francisco
  More Information

Responsible Party: Mark Jacobson, Professor of Medicine, UCSF Identifier: NCT00373412     History of Changes
Other Study ID Numbers: Jacobson VCL CT-02 TC
Study First Received: September 6, 2006
Last Updated: May 5, 2008

Keywords provided by University of California, San Francisco:
T cell

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017