Evaluate the Safety and Immunogenicity of a Seasonal Influenza VLP Vaccine (Recombinant) in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2a Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Safety and
      Immunogenicity of a Seasonal Influenza Virus-Like Particle (VLP) Vaccine (recombinant) in
      Healthy Adults.

      Study Objectives:

      Primary:

        -  To assess the tolerability and safety of Influenza VLP Vaccine

        -  To assess the immunogenicity of Influenza VLP Vaccine as measured by hemagglutination
           inhibition (HAI) antibody titers to each of the three component viral strains

      Secondary:

        -  To evaluate the cross-strain immunogenicity of Influenza VLP Vaccine as measured by
           hemagglutination inhibition (HAI) antibody titers against drifted strains

        -  To quantify antibody against neuraminidase and hemagglutinin following administration of
           Influenza VLP Vaccine

        -  To assess cell-mediated immune (CMI) responses to Influenza VLP Vaccine as quantified by
           interferon-gamma (IFNg) and Granzyme-B produced by peripheral blood mononuclear cells
           (PBMCs).
    

Detailed description: 
      Study Design:

      This is a Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety,
      tolerability and immunogenicity of three dose levels (low, middle or high) of Influenza VLP
      Vaccine or placebo in healthy adults(18 to 49 years of age).

      Eligible subjects will provide a blood sample for baseline evaluation of immunological
      measures followed by a single intramuscular (IM) injection of Influenza VLP Vaccine or
      placebo (Day 1).

      Subjects will be monitored in the clinic for a period of at least 30 minutes following
      vaccination for the occurrence of adverse events including local injection site reactions and
      systemic responses. For 7 days following vaccination and beginning the day of vaccination,
      subjects will maintain a symptom diary for daily recording of injection-site reactions as
      well as generalized systemic reactions including measurement of body temperature. Clinic
      staff will contact the subjects by telephone 2 days post vaccination (Day 3) to check for
      adverse events and to answer any questions related to collection of symptom diary
      information. Subjects will return to the clinic 7 days following vaccination (Day 8) for
      safety evaluation that will include a review of diary card information. A subset of subjects
      will additionally return to the clinic 10-14 days following vaccination (Days 11-15) to
      provide a blood sample for evaluation of cell-mediated immune (CMI) responses. All subjects
      will return to the clinic 21 days following injection (Day 22) for a safety evaluation and to
      provide a blood sample for measurement of humoral immunological parameters. A final safety
      evaluation (telephone contact) will occur at approximately 6 months following vaccination
      (Day 181).

      The study will be conducted as a parallel group design with a total of approximately 300
      subjects (18 to 49 years of age) randomly assigned to one of 4 treatment arms (high, middle,
      low and placebo) in a 2:2:1:1 ratio. The following is a summary of subject allocation to
      treatment:

      Subject Allocation Treatment Condition Number of Subjects High dose vaccine/ 0.5 mL - 100
      Middle dose vaccine/ 0.5 mL - 100 Low dose vaccine/ 0.5 mL - 50 Placebo (0.5 mL) - 50
    

Intervention name(s): Influenza VLP Vaccine (recombinant); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single injection Day 0; 0.5mL; Placebo as a single injection of 0.5 mL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention