Vaccine Therapy in Preventing Cytomegalovirus in Healthy Participants
Condition: Nonneoplastic Condition
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Vaccines made from peptides may help the body build an immune response to kill
      cytomegalovirus.

      PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in
      preventing cytomegalovirus in healthy participants.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To establish whether 3 vaccine dose levels of PADRE-CMV and tetanus-CMV fusion peptide
           vaccines are safe and well tolerated in healthy cytomegalovirus (CMV)-seropositive or
           -seronegative participants.

        -  To establish safe dose levels for the PADRE-CMV and tetanus-CMV fusion peptide vaccines
           in combination with PF 03512676 DNA in these participants.

      Secondary

        -  To provide preliminary evidence of enhanced cellular immunity to CMV at levels of T
           cells that would support potential feasibility if such cells were to be transferred from
           the donor to recipients of hematopoietic stem cell transplantation (HSCT) in amounts
           consistent with protection against disease.

        -  To determine whether a reduced dose of peptide vaccine can be immunogenic in combination
           with PF 03512676 DNA.

        -  To confer CMV-specific cytotoxic T-lymphocyte (CTL) function to CMV-negative
           participants.

        -  To determine the duration of immune enhancement of CMV-specific CTL function up to 12
           months following immunization of healthy participants.

      OUTLINE: This is a dose-escalation study of PADRE-CMV and tetanus-CMV fusion peptide
      vaccines. Participants are stratified according to cytomegalovirus (CMV) serum status
      (positive vs negative). Participants are assigned to 1 of 2 groups.

        -  Group A: Participants receive either PADRE-CMV fusion peptide vaccine or tetanus-CMV
           fusion peptide vaccine subcutaneously (SC) on days 1, 21, 42, and 63 in the absence of
           unacceptable toxicity.

        -  Group B: Participants receive either PADRE-CMV fusion peptide vaccine in CpG 7909
           adjuvant SC or tetanus-CMV fusion peptide vaccine in CpG 7909 adjuvant SC on days 1, 21,
           42, and 63 in the absence of unacceptable toxicity.

      Participants are contacted by telephone every 3-7 days after immunization. Participants also
      complete a notebook on any health-related event for 14 days after each immunization.

      Participants undergo blood sample collection at baseline and periodically during study for
      immunologic laboratory studies, including flow cytometry, by HLA-A2-CMV-tetramer,
      CMV-specific intracellular cytokine, CMV-specific CD107 degranulation, lymphoproliferation,
      and chromium release assays.

      After completion of study therapy, participants are followed for up to 1 year.
    

Intervention name(s): PADRE-CMV fusion peptide vaccine; tetanus-CMV fusion peptide vaccine; agatolimod sodium
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Given subcutaneously; Given subcutaneously; Given subcutaneously
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cytomegalovirus infection