Immunogenicity, Safety, Tolerability of a Plant-made H5 VLP Influenza Vaccine.

NCT01991561 Phase 2 COMPLETED

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.

Details

Lead sponsor	Medicago
Phase	Phase 2
Status	COMPLETED
Enrolment	390
Start date	2013-06
Completion	2014-11

Conditions

• Virus Diseases
• RNA Virus Infections
• Respiratory Tract Diseases
• Respiratory Tract Infections

Interventions

• 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

Primary outcomes

• Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus — 21 days after each injection
  Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 21).
• Levels of antibodies induced against the H5 of the H5N1/A/Indonesia/5/05, clade 2.1 virus — 42 days after each injection
  Immunogenicity Geometric mean titers (GMTs) of hemagglutination inhibition (HI antibody on Day 42).

Countries

Canada