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

Sponsors and Collaborators:	University of California, San Francisco Vical
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00373412

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:

antibody titers for gB;
T-cell IFN-g ELISPOT;
T-cell proliferation assays for IE1, pp65, and/or gB; and
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 I

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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

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

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

Responsible Party:	UCSF ( Mark Jacobson, Professor of Medicine )
Study ID Numbers:	Jacobson VCL CT-02 TC
Study First Received:	September 6, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00373412
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:

cytomegalovirus
vaccine
T cell
antibodies

Study placed in the following topic categories:

Virus Diseases
Antibodies
Cytomegalovirus Infections
DNA Virus Infections
Healthy

Cytomegalic inclusion disease
Cytomegalovirus
Immunoglobulins
Herpesviridae Infections

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on January 14, 2009