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OpenTrials
Completed

NCT Number: NCT00373412

Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge

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, and/or gB; and 4. 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.

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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

Primary location

UCSF Positive Health Program, 995 Potrero, 4th Floor

San Francisco, California, 94110, United States

About this study

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.

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
  • Normal lab values at study entry
  • Good general health
  • Negative CMV IgG antibody test

Exclusion criteria

  • CMV seropositive
  • Recent vaccination(s)
  • Immunodeficiency
  • Vaccination with investigational CMV vaccine(s)
  • Pregnant or breast-feeding

Treatment and study plan

VCL CT02 pDNA vaccine

Biological

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

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

Important dates

Study start
2006
Primary completion
2008
First posted
Sep 8, 2006
Registry last updated
May 8, 2008

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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