NCT01991587

Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults

Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent Virus-like-particle (VLP) Influenza Vaccine in Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Medicago · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age. A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP 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

The Phase 1 portion of 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 thirteen subjects (13) subjects will be randomized, of these ten (10) will be dosed with the lowest dose of the quadrivalent VLP vaccine and three (3) 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 one external medical expert, prior to permitting immunization with the medium dose level. * Cohort 2: A second cohort of thirteen subjects (13) subjects will be randomized; of these, ten (10) will be dosed with the medium dose of the quadrivalent VLP vaccine and three (3) 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 fourteen subjects (14) subjects will be randomized; of these ten (10) dosed with the high dose of the quadrivalent VLP vaccine and four (4) will receive a placebo. The 7-day safety data after the immunization will be collected and reviewed by the DSMB. If the 7-day post-immunization safety data of this cohort is satisfactory according to the DSMB review, the Phase 2 portion of the study will proceed. The Phase 2 portion of this study will be an observer-blind, randomized, dose-ranging study of the 3 different vaccine doses or a placebo. Therefore, the remaining 20 subjects per vaccine dose will be dosed with the remaining 20 subjects of the placebo group. 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: 2013-10-08
• Primary completion: 2014-06-30
• Completion: 2014-06-30
• First posted: 2013-11-25
• Last updated: 2020-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study