Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent 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 2

Summary: 
      A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled
      study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular
      injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to
      healthy adults 18-49 years of age.

      A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to
      receive one injection of either a low, a medium, or a high dose level 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: 
      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 one hundred nineteen subjects (119) will be randomized; of
           these, seventy five (75) will be dosed with the lowest dose of the quadrivalent VLP
           vaccine, nineteen (19) will be dosed with the medium dose of the quadrivalent VLP
           vaccine, and twenty five (25) 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
           three external medical experts as voting members, prior to permitting immunization with
           the cohort 2.

        -  Cohort 2: A second cohort of one hundred subjects (100) subjects will be randomized; of
           these, fifty six (56) will be dosed with the medium dose of the quadrivalent VLP
           vaccine, nineteen (19) be dosed with the high dose of the quadrivalent VLP vaccine, and
           twenty five (25) 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 eighty one subjects (81) subjects will be randomized; of
           these fifty six (56) dosed with the high dose of the quadrivalent VLP vaccine and twenty
           five (25) will receive a placebo.

      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