Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373412
Status:
COMPLETED
Last Update Posted:
2008-05-08
First Post:
2006-09-06
Brief Title:
Trial of pDNA CMV Vaccine VCL-CT02 Followed by Towne CMV Vaccine Towne Challenge
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 antibody titers for gB
2 T-cell IFN-g ELISPOT
3 T-cell proliferation assays for IE1 pp65 andor gB and
4 cytokine and phenotypic flow cytometry responses to pp65 IE1 andor 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
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 antibody titers for gB
2 T-cell IFN-g ELISPOT
3 T-cell proliferation assays for IE1 pp65 andor gB and
4 cytokine and phenotypic flow cytometry responses to pp65 IE1 andor 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
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 N6or control N6 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
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 N6or control N6 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None