NCT01244867

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

A Phase 2, Randomized, Observer-blind, Single Center, Dose-Ranging Study to Evaluate the Immunogenicity Safety and Tolerability of the H5 VLP Influenza Vaccine With or Without Alhydrogel in Healthy Adults 18-60 Years of Age.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 255 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	20 micrograms dose H5 VLP	2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel
BIOLOGICAL	30 micrograms dose H5 VLP	2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel
BIOLOGICAL	45 micrograms dose H5 VLP	2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel
BIOLOGICAL	45 micrograms non-adjuvanted H5 VLP	2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine
BIOLOGICAL	Placebo	2 doses given 21 days apart of the placebo

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-07-01
• Completion: 2011-09-01
• First posted: 2010-11-19
• Last updated: 2012-07-31

Locations

1 site across 1 country: Canada