NCT02022163

Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.

Detailed description

This study will consist of a dose-ranging in one hundred (100) subjects who will be randomized in parallel to a 1:1:1:1:1 ratio in five (5) groups of 20 subjects to receive one intramuscular injection at Days 0 and 21 of either a low, medium or high dose of H7 VLP vaccine mixed with Alhydrogel® 0.4% (0.5 mg Aluminum per dose) or a high dose of H7 VLP alone or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80). 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 228.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Low dose of H7 VLP vaccine + Alhydrogel	Low dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
BIOLOGICAL	Med dose of H7 VLP vaccine + Alhydrogel	Med dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
BIOLOGICAL	High dose of H7 VLP vaccine + Alhydrogel	High dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
BIOLOGICAL	High dose of H7 VLP vaccine	High dose of H7 VLP vaccine, 2 doses given 21 days apart
BIOLOGICAL	Placebo	Placebo, 2 doses given 21 days apart

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2013-12-27
• Last updated: 2015-09-25

Locations

1 site across 1 country: Canada