Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.
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 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the
      Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine
      adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in
      healthy adults 18-60 years of age.
    

Detailed description: 
      This study will consist of a dose-ranging in 390 subjects who will be randomized to receive
      one injection at Days 0 and 21 of either a low, medium or a high dose of H5 VLP Influenza
      vaccine combined with Alhydrogel®, or a low or high dose of H5 VLP Influenza vaccine combined
      with GLA-SE, or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM Sodium
      Chloride (NaCl) + 0.01% Tween 80). Seven-day (7) safety data after the first immunization of
      the first 25% study subjects enrolled (98 subjects) will be tabulated and reviewed by the
      Data and Safety Monitoring Board (DSMB), prior to permitting the first immunization of the
      remaining study subjects and the second immunisations. Also, based on medical expert opinion
      and on safety criteria defined in the protocol, a DSMB review might be necessary on the
      seven-day safety data of the same 25% study subjects following administration of their second
      dose, before proceeding to the second immunizations of the remaining study subjects.
      Twenty-one (21) days after each immunization, key safety and immunogenicity data will be
      collected and analysed. All subjects will be followed for safety until Day 407.
    

Intervention name(s): Low dose of H5 VLP vaccine + Alhydrogel; Med dose of H5 VLP vaccine + Alhydrogel; High dose of H5 VLP vaccine + Alhydrogel; Low dose of H5 VLP vaccine + GLA-SE; High dose of H5 VLP vaccine + GLA-SE; Placebo comparator: Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel; Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel; Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel; Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE; Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE; Biological: Placebo 2 doses given 21 days apart of the placebo
Intervention MeSH terms: Aluminum Hydroxide; Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza, Human; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections; Aluminum Hydroxide; Adjuvants, Immunologic; Immunogenic Factors; GLA-SE; Physiological Effects of Drugs; Virus Diseases; Orthomyxoviridae Infections; Infection