A Phase 1/2 Clinical Trial of an Alphavirus Replicon Vaccine for Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      AVX502, an alphavirus replicon vaccine expressing an influenza HA protein, is a candidate
      vaccine against influenza.

      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 18-40 years of age. Volunteers will be assigned
      by randomization to receive either the vaccine or an inactive substance (placebo) by
      injections in each arm on one or two occasions over 2 months. The study will last 4 months
      and will have a total of 8 visits.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled Phase 1/2 study of the safety and
      immunogenicity of AVX502 vaccine at two dosage levels and two routes of administration in
      healthy volunteers conducted at a single research center. A total of 216 participants will be
      enrolled. Participants will be randomized to receive active vaccine at one of two dosage
      levels or placebo in a 4:4:1 ratio. Within each active dosage level or placebo subgroup,
      participants will be randomized to receive their injections by either IM or SC injection in a
      1:1 ratio, and will also be randomized to receive either 1 injection (at Week 0) or 2
      injections (1 at each of two visits at Weeks 0 and 8) in a 1:1 ratio. Vaccine will be
      administered by a study nurse in an outpatient setting and all participants will be followed
      for 4 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 HA by ELISA and
      hemagglutination inhibition assays and to the vaccine vector by a VRP neutralization assay)
      and peripheral blood mononuclear cells (PMBC) (for measurement of cellular immune responses
      to HA peptides).
    

Intervention name(s): AVX502; AVX502; AVX502; AVX502; AVX502; AVX502; AVX502; AVX502; Placebo; Placebo; Placebo; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 1 dose at 2e8 IU given at t=0 via IM route; 1 dose at 2e7 IU given at T=0 via the IM route; 1 dose at 2e7 IU given at t=0 via the SC route; 1 dose at 2e8 IU given at T=0 via the SC route; 2 doses at 2e7 IU given at T=0 and 8 weeks via the IM route; 2 doses at 2e8 IU given at T=0 and 8 weeks via the IM route; 2 doses of 2e7 IU given at t=0 and 8 weeks via the SC route; 2 doses at 2e8 IU given at T=0 and 8 weeks via the SC route; 1 dose of placebo given at T=0 via the IM route; 1 dose of placebo given at T=0 via the SC route; 2 doses of placebo given at T=0 and 8 weeks via the IM route; 2 doses of placebo given at T=0 and 8 weeks via the SC route
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Influenza; Flu; A/Wyoming/03/2003; Alphavirus