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Sponsors and Collaborators: |
University of California, San Francisco Vical |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00370006 |
Objectives of this trial are to:
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).
Condition | Intervention | Phase |
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Cytomegalovirus Infection |
Biological: Towne CMV vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 10 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | August 2007 |
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
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.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:18 to 45 years of age at the time of initial enrollment in trial CT02-ID; normal lab values at study entry; good general health; CMV IgG antibody test < 4 times last measured value (i.e., at Week 32 after VCL-CT02 administration in CT02-ID was initiated)
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Exclusion Criteria:CMV seropositive; recent vaccination(s); immunodeficiency; vaccination with investigational CMV vaccine(s) other than VCL-CT02 ; pregnant or breast-feeding
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Study ID Numbers: | Jacobson VCL CT-02 IDTC |
Study First Received: | August 28, 2006 |
Last Updated: | January 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00370006 |
Health Authority: | United States: Food and Drug Administration |
cytomegalovirus vaccine T cell antibodies |
Virus Diseases Antibodies Cytomegalovirus Infections DNA Virus Infections Healthy |
Cytomegalic inclusion disease Cytomegalovirus Immunoglobulins Herpesviridae Infections |
Infection |