Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
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|ClinicalTrials.gov Identifier: NCT00373412|
Recruitment Status : Completed
First Posted : September 8, 2006
Last Update Posted : May 8, 2008
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 or disease||Intervention/treatment||Phase|
|Cytomegalovirus Infection||Biological: VCL CT02 pDNA vaccine Biological: Towne CMV vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||February 2008|
- 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.
- Safety of Towne challenge in subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373412
|United States, California|
|UCSF Positive Health Program, 995 Potrero, 4th Floor|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Mark A Jacobson, MD||University of California, San Francisco|