Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM

NCT ID: NCT00370006

Last Updated: 2007-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2007-08-31

Brief Summary

Objectives of this trial are to:

1. Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge (3000 pfu) in healthy CMV-seronegative volunteers who received VCL CT02 administered ID or IM 9 to 15 months previously as measured by: 1) ELISA and/or virus-neutralizing antibody titers for gB; 2) T-cell IFN-g ELISPOT; 3) T-cell proliferation assays (CFSE) for IE1, pp65, and/or gB; and possibly 4) cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.

2. 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 (IM) or intradermally (ID).

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 (concurrent controls will be administered Towne alone in a concurrent, companion trial).

Detailed Description

This is a Phase 1, single-center, open-label trial of the live, attenuated Towne CMV vaccine administered as a "challenge" to healthy, CMV-seronegative, adult subjects who previously received the CMV immunotherapeutic trivalent pDNA-based vaccine, VCL-CT02, given by intradermal or intramuscular routes as described in the following table; these subjects have been followed for 32 weeks.

Table 6.1 Subject Distribution Group Formulation Dosing Regimen (day) Dose per Injection(Administered to the deltoid region) Route of Administration Number of Subjects

1. VCL-CT02 0, 28, 56 1.0 mg Intramuscular (IM) 6

2. VCL-CT02 0, 28, 56 100 μg/injection × 2 injections Intradermal (ID) 11 Total 17

Up to 10 subjects from Groups 1 and 2 will be approached for enrollment in the current protocol. If a subject consents and meets all eligibility criteria, the subject will receive Towne (3000 pfu subcutaneously) between 9 and 15 months after the subject's first dose of VCL-CT02. 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.

Conditions

Cytomegalovirus Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Towne CMV vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vical

INDUSTRY

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Principal Investigators

Mark A Jacobson, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

Jacobson VCL CT-02 IDTC

Identifier Type: -

Identifier Source: org_study_id