NCT00373412

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. 1.antibody titers for gB;
  2. 2.T-cell IFN-g ELISPOT;
  3. 3.T-cell proliferation assays for IE1, pp65, and/or gB; and
  4. 4.cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Last Updated

May 8, 2008

Status Verified

October 1, 2006

Enrollment Period

1.3 years

First QC Date

September 6, 2006

Last Update Submit

May 5, 2008

Conditions

Cytomegalovirus Infection

Keywords

cytomegalovirusvaccineT cellantibodies

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

VCL CT02 pDNA vaccineBIOLOGICAL
Towne CMV vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Positive Health Program, 995 Potrero, 4th Floor

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Mark A Jacobson, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2006

First Posted

September 8, 2006

Study Start

October 1, 2006

Primary Completion

February 1, 2008

Last Updated

May 8, 2008

Record last verified: 2006-10

Locations

US(1)