Cytomegalovirus Vaccine in Healthy Participants
Condition: Precancerous/Nonmalignant Condition
MeSH terms: Precancerous Conditions
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines may help the body build an effective immune response against
      cytomegalovirus.

      PURPOSE: This randomized phase I trial is studying the side effects and best dose of
      cytomegalovirus vaccine in healthy participants.
    

Detailed description: 
      OBJECTIVES:

        -  To establish whether 4 dose levels of the CMVpp65-A*0201 peptide vaccine are safe and
           well tolerated in cytomegalovirus (CMV)-seropositive participants.

        -  To determine whether the CMVpp65-A*0201 peptide vaccine, when given as a single
           injection followed by one booster injection at a safe and well-tolerated dose, is
           capable of stimulating a memory response in CMV-seropositive participants.

        -  To evaluate whether CMV-seronegative participants generate a de novo immune response
           against CMV after immunization with CMVpp65-A*0201 peptide vaccine given as a single
           injection followed by three booster injections.

        -  To determine the duration of immune enhancement of CMV-specific cytotoxic T-lymphocyte
           function as assessed for up to 12 months after primary or secondary immunization with
           the CMVpp65-A*0201 peptide vaccine.

      OUTLINE: This is a dose-escalation study of CMVpp65-A*0201 peptide vaccine in cytomegalovirus
      (CMV)-seropositive participants. Once a safe dose is established, CMV-seronegative
      participants are accrued and immunized at that dose. Participants are stratified according to
      gender.

        -  CMV-seropositive participants: Participants are randomized to receive 1 of 4 escalating
           doses of CMVpp65-A*0201 peptide vaccine containing either helper T-lymphocyte (HTL)
           PADRE peptide or HTL tetanus toxoid peptide. Within each vaccine dose group, two
           participants are randomized to receive a placebo. Participants receive the vaccine or a
           placebo subcutaneously (SC) on days 0 and 28 in the absence of unacceptable toxicity.

        -  CMV-seronegative participants: Participants are randomized to receive 1 of 4 established
           doses (established in CMV-seropositive participants) of CMVpp65-A*0201 peptide vaccine
           containing either HTL PADRE peptide or HTL tetanus toxoid peptide. Participants receive
           the vaccine on days 0, 28, and 56 in the absence of unacceptable toxicity. Participants
           with a partial or low-level immune response receive one additional booster vaccine on
           day 90.

      Participants undergo blood sample collection at baseline and periodically during study for
      immunologic laboratory studies. Participants also undergo skin biopsy at baseline. Laboratory
      studies include assessment of human cytotoxic T-lymphocyte activity and response by
      ^51chromium-release assay, limiting-dilution analysis, and T-cell proliferation assay; and
      CD4/CD8 phenotyping by FACScan® flow cytometry.

      After completion of study therapy, participants are followed for 12 months.
    

Intervention name(s): CMVpp65-A*0201 peptide vaccine
Intervention type(s): Biological
Intervention description(s): Vaccine received on either days 0 and 28 or on days 0, 28, and 56 and perhaps day 90
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: cytomegalovirus infection