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OpenTrials
Completed

NCT Number: NCT00370006

Phase 1 Trial of CMV Towne Vaccine in Subjects Previously Received VCL CT02 Vaccine ID or IM

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).

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).

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Key information

Conditions

Cytomegalovirus Infection Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

  • VCL-CT02 0, 28, 56 1.0 mg Intramuscular (IM) 6
  • VCL-CT02 0, 28, 56 100 μg/injection × 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

-

Exclusion criteria

CMV seropositive; recent vaccination(s); immunodeficiency; vaccination with investigational CMV vaccine(s) other than VCL-CT02 ; pregnant or breast-feeding

-

Treatment and study plan

Towne CMV vaccine

Biological

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).

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Vical

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Aug 30, 2006
Registry last updated
Jan 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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