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

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ClinicalTrials.gov Identifier: NCT00373412
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : May 8, 2008
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Collaborator:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Biological: VCL CT02 pDNA vaccine Biological: Towne CMV vaccine Phase 1

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2006
Primary Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).

Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373412


Locations
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
Vical
Investigators
Principal Investigator: Mark A Jacobson, MD University of California, San Francisco
More Information

Responsible Party: Mark Jacobson, Professor of Medicine, UCSF
ClinicalTrials.gov Identifier: NCT00373412     History of Changes
Other Study ID Numbers: Jacobson VCL CT-02 TC
First Posted: September 8, 2006    Key Record Dates
Last Update Posted: May 8, 2008
Last Verified: October 2006

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

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs