Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM
A Phase 1 Clinical Trial to Evaluate the Safety of, and Kinetics and Magnitude of the CMV-Specific Immune Response to, Challenge With a Live Attenuated Strain of CMV (Towne) in Healthy, CMV- Seronegative, Adult Subjects Who Previously Received a CMV Immunotherapeutic Trivalent pDNA Vaccine (VCL CT02) Administered Intradermally or Intramuscularly
1 other identifier
interventional
10
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2006
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
August 28, 2006
CompletedFirst Posted
Study publicly available on registry
August 30, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJanuary 11, 2007
October 1, 2006
August 28, 2006
January 10, 2007
Conditions
Keywords
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
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Franciscolead
- Vicalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Jacobson, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 28, 2006
First Posted
August 30, 2006
Study Start
September 1, 2006
Study Completion
August 1, 2007
Last Updated
January 11, 2007
Record last verified: 2006-10