NCT01991561

Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Low dose of H5 VLP vaccine + Alhydrogel	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 + 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 + 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 + GLA-SE	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 + 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 comparator: Placebo	Biological: Placebo 2 doses given 21 days apart of the placebo

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-07-01
• Completion: 2014-11-01
• First posted: 2013-11-25
• Last updated: 2020-06-11

Locations

2 sites across 1 country: Canada