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

This study has been completed.
Sponsor:
Collaborator:
Vical
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00373412
First received: September 6, 2006
Last updated: May 5, 2008
Last verified: October 2006
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mark Jacobson, Professor of Medicine, UCSF
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cytomegalovirus Infections
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014