Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging,
      placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single
      intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine
      administered to healthy adults 18-49 years of age.

      A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30
      subjects to receive one injection of either a low, a medium, or a high dose level of VLP of
      the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM)
      phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).
    

Detailed description: 
      The Phase 1 portion of this study will be a dose escalation, cohort staggering (slow
      enrollment) for the 3 dose levels (low, medium or high dose level) with a placebo-controlled
      group:

        -  Cohort 1: A first cohort of thirteen subjects (13) subjects will be randomized, of these
           ten (10) will be dosed with the lowest dose of the quadrivalent VLP vaccine and three
           (3) will receive a placebo. The 7-day safety data after the immunization will be
           collected and reviewed by the Data and Safety Monitoring Board (DSMB) consisting of the
           Principal Investigator (PI), the Sponsor's Medical Officer and one external medical
           expert, prior to permitting immunization with the medium dose level.

        -  Cohort 2: A second cohort of thirteen subjects (13) subjects will be randomized; of
           these, ten (10) will be dosed with the medium dose of the quadrivalent VLP vaccine and
           three (3) will receive a placebo. The 7-day safety data after the immunization will be
           collected and reviewed by the DSMB, prior to permitting immunization with the highest
           dose.

        -  Cohort 3: A third cohort of fourteen subjects (14) subjects will be randomized; of these
           ten (10) dosed with the high dose of the quadrivalent VLP vaccine and four (4) will
           receive a placebo. The 7-day safety data after the immunization will be collected and
           reviewed by the DSMB. If the 7-day post-immunization safety data of this cohort is
           satisfactory according to the DSMB review, the Phase 2 portion of the study will
           proceed.

      The Phase 2 portion of this study will be an observer-blind, randomized, dose-ranging study
      of the 3 different vaccine doses or a placebo. Therefore, the remaining 20 subjects per
      vaccine dose will be dosed with the remaining 20 subjects of the placebo group.

      Three (3) and 21 days after immunization, key safety (Day 3) and immunogenicity (Day 21) data
      will be collected and analyzed. All subjects will be followed for safety until Day 201
      (6-month follow up), regardless the phase of the study.
    

Intervention name(s): Low dose of quadrivalent VLP vaccine; Medium dose of quadrivalent VLP vaccine; High dose of quadrivalent VLP vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): A single low dose of quadrivalent VLP vaccine; A single medium dose of quadrivalent VLP vaccine; A single high dose of quadrivalent VLP vaccine; A single dose of placebo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Human; RNA Virus Infections; Immunologic; Immunogenic Factors; Physiological Effects of Drugs; Virus diseases; Orthomyxoviridae Infections; Infection