NCT02233816

Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults

Immunogenicity, Safety, and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A phase II trial multicenter, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-derived Seasonal VLP Quadrivalent Influenza Vaccine administered to healthy adults 18-49 years of age. A total of three hundred subjects will be randomized in four (4) groups of 75 subjects to receive one injection of either a low, a medium, or a high dose level of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

Detailed description

This study will be a dose escalation, cohort staggering (slow enrollment) for the 3 dose levels (low, medium or high dose level) with a placebo-controlled group: * Cohort 1: A first cohort of one hundred nineteen subjects (119) will be randomized; of these, seventy five (75) will be dosed with the lowest dose of the quadrivalent VLP vaccine, nineteen (19) will be dosed with the medium dose of the quadrivalent VLP vaccine, and twenty five (25) will receive a placebo. The 7-day safety data after the immunization will be collected and reviewed by the Data and Safety Monitoring Board (DSMB) consisting of the Principal Investigator (PI), the Sponsor's Medical Officer and three external medical experts as voting members, prior to permitting immunization with the cohort 2. * Cohort 2: A second cohort of one hundred subjects (100) subjects will be randomized; of these, fifty six (56) will be dosed with the medium dose of the quadrivalent VLP vaccine, nineteen (19) be dosed with the high dose of the quadrivalent VLP vaccine, and twenty five (25) will receive a placebo. The 7-day safety data after the immunization will be collected and reviewed by the DSMB, prior to permitting immunization with the highest dose. * Cohort 3: A third cohort of eighty one subjects (81) subjects will be randomized; of these fifty six (56) dosed with the high dose of the quadrivalent VLP vaccine and twenty five (25) will receive a placebo. Three (3) and 21 days after immunization, key safety (Day 3) and immunogenicity (Day 21) data will be collected and analyzed. All subjects will be followed for safety until Day 201 (6-month follow up), regardless the phase of the study.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Low dose of quadrivalent VLP vaccine	A single low dose of quadrivalent VLP vaccine
BIOLOGICAL	Medium dose of quadrivalent VLP vaccine	A single medium dose of quadrivalent VLP vaccine
BIOLOGICAL	High dose of quadrivalent VLP vaccine	A single high dose of quadrivalent VLP vaccine
BIOLOGICAL	Placebo	A single dose of placebo

Timeline

• Start date: 2014-07-28
• Primary completion: 2015-06-22
• Completion: 2015-06-22
• First posted: 2014-09-08
• Last updated: 2019-11-13

Locations

2 sites across 1 country: United States