Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370006
Status:
COMPLETED
Last Update Posted:
2007-01-11
First Post:
2006-08-28
Brief Title:
Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor virus-neutralizing antibody titers for gB 2 T-cell IFN-g ELISPOT 3 T-cell proliferation assays CFSE for IE1 pp65 andor gB and possibly 4 cytokine and phenotypic flow cytometry responses to pp65 IE1 andor 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
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 andor virus-neutralizing antibody titers for gB 2 T-cell IFN-g ELISPOT 3 T-cell proliferation assays CFSE for IE1 pp65 andor gB and possibly 4 cytokine and phenotypic flow cytometry responses to pp65 IE1 andor 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 61 Subject Distribution Group Formulation Dosing Regimen day Dose per InjectionAdministered to the deltoid region Route of Administration Number of Subjects
1 VCL-CT02 0 28 56 10 mg Intramuscular IM 6
2 VCL-CT02 0 28 56 100 μginjection 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 subjects 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
Table 61 Subject Distribution Group Formulation Dosing Regimen day Dose per InjectionAdministered to the deltoid region Route of Administration Number of Subjects
1 VCL-CT02 0 28 56 10 mg Intramuscular IM 6
2 VCL-CT02 0 28 56 100 μginjection 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 subjects 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
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