Respiratory Tract Infections Clinical Trial
Official title:
Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent Virus-like-particle (VLP) Influenza Vaccine in Adults
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).
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.
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