A Clinical Trial of an Alphavirus Replicon Vaccine for Cytomegalovirus (CMV)
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      AVX601, a bivalent alphavirus replicon vaccine expressing three CMV proteins (gB, pp65 and
      IE1) is a candidate vaccine against cytomegalovirus (CMV).

      The objectives of this Phase 1 study are to test the safety of the vaccine and the immune
      response to the vaccine in healthy volunteers who have not previously been infected with CMV.
      Volunteers will be assigned by randomization to receive either the vaccine or an inactive
      substance (placebo) by injections in each arm on three occasions over 6 months. The study
      will last 12 months and will have a total of 12 visits.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled Phase 1 study of the safety and
      immunogenicity of AVX601 vaccine at two dosage levels and two routes of administration in
      healthy volunteers conducted at a single research center. A total of 40 participants will be
      enrolled into two groups of 20 participants each. Within each group, participants will be
      randomized to receive the active vaccine by IM injection (N = 8) or SC injection (N = 8) or
      to receive a placebo by IM injection (N = 2) or SC injection (N = 2). Each participant will
      receive a total of six injections of vaccine or placebo, two at each visit at Weeks 0, 8 and
      24, administered by a study nurse in an outpatient setting, and will be followed for 12
      months after the first immunization. Safety data will include local and systemic
      reactogenicity after each dose of vaccine, collected in a systematic format using a subject
      memory aid and a standard grading scale, specific safety laboratory parameters and general
      AEs. Immunogenicity data will be obtained by collecting blood at defined time points before
      and after immunization and separating serum (for measurement of antibodies to CMV by ELISA
      and neutralization assays and to the vaccine vector by a VRP neutralization assay) and
      peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses to
      CMV peptides).
    

Intervention name(s): AVX601; Placebo; AVX601; Placebo; AVX601; AVX601; AVX601; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the IM route; 3 doses of placebo given at T=0, 8, 24 weeks via the IM route; 3 doses of AVX601 at 1e7 IU given at T=0, 8, 24 weeks via the SC route; 3 doses of placebo given at T=0, 8, 24 weeks via the SC route; 3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the IM route; 3 doses of placebo given at T=0, 8, 24 weeks via the IM route; 3 doses of AVX601 at 1e8 IU given at T=0, 8, 24 weeks via the SC route; 3 doses of placebo given at T=0, 8, 24 weeks via the SC route
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: CMV; cytomegalovirus; Alphavirus