Respiratory Tract Infections Clinical Trial
Official title:
Immunogenicity, Safety, and Tolerability of a Plant-Derived Seasonal Virus-Like-Particle Quadrivalent Influenza Vaccine in Adults
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).
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.
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