Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine
Condition: Virus Diseases; RNA Virus Infections; Respiratory Tract Diseases; Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; RNA Virus Infections; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to assess the immunogenicity and safety and tolerability of two
      consecutive doses of H5 VLP Influenza vaccine given 21 days apart, at three dose levels: in
      part A: 20 µg, 30 µg and 45 µg combined with Alhydrogel® 1%, or 45 µg without Alhydrogel®,
      compared to the placebo, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween 80).
    

Detailed description: 
      An adaptive design is proposed for this phase 2 trial. Part A of this study will consist of
      dose-ranging in 135 subjects who will be randomized to receive one injection of either 20 µg,
      30 µg or 45 µg H5 VLP Influenza vaccine combined with Alhydrogel®, or 45 µg without
      Alhydrogel®, or the placebo preparation, (100mM phosphate buffer + 150mM NaCl + 0.01% Tween
      80) at Days 0 and 21. Seven-day (7) safety data after the first immunization for subjects in
      all five treatment groups will be tabulated and reviewed by a panel consisting of 2 external
      medical advisors, prior to permitting the second immunization of vaccine/placebo for all
      treatment groups at Day 21 (Part A). Twenty-one (21) days after the last subject vaccine
      administration in Part A, all safety and immunogenicity data will be collected and analysed
      to determine the optimal dose level. Following selection of the optimal dose, Part B of the
      trial will commence and consist of administration of the selected optimal dose(s) in one
      hundred (100) subjects, plus administration of placebo in twenty (20) subjects (total of 120
      subjects in part B). These subjects will similarly receive two vaccinations 21 days apart and
      will be followed in the exact same fashion as Part A, except that there will be no 7-day
      safety analysis. Depending on data analysis one or a maximum of two vaccine doses could be
      selected to be further evaluated during part B of the trial. All Part A and B subjects will
      be followed for safety until Day 228.
    

Intervention name(s): 20 micrograms dose H5 VLP; 30 micrograms dose H5 VLP; 45 micrograms dose H5 VLP; 45 micrograms non-adjuvanted H5 VLP; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel; 2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel; 2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel; 2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine; 2 doses given 21 days apart of the placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention