"Multimeric-001" (M-001) contains conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to pandemic influenza vaccine in the adult population. The current clinical study was designed to assess M-001's standalone and priming action in subjects aged 18-60 years old. This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.
This is a multi-center, randomized, double blind active-controlled Phase 2b study. 222 subjects will be randomized 1:1:1 into three groups to receive two sequential non-adjuvanted 0.5 mg or 1.0mg intramuscular injection of M-001 (treatment), or two placebo (saline) injection, before receiving the Alum adjuvanted H5N1 vaccine at a sub optimal dose of 3mcg. Hemagglutinin inhibition (HAI) will be evaluated at baseline and 3 weeks after H5N1 whole virion inactivated pandemic influenza vaccination as a measure of M-001's ability to enhance the humoral response. Cell mediated immune (CMI) responses will also be evaluated at baseline and after immunization with M-001 as a measure of M-001's standalone immunogenicity. The subjects will monitored for safety throughout the study until day 180.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
224
Multimeric 001 is a recombinant protein comprising 9 conserved peptides from influenza A and B
Alum adjuvanted whole virion inactivated H5N1 vaccine produced by FluArt (Hungary)
0.9% NaCl in double distilled water
St Istvan St laszlo Hospital
Budapest, Hungary
For each vaccine group the incidence rate of subjects with solicited AE(s) with 95% confidence interval
All subjects
Time frame: Day 0 to Day 42 (21 days after the last M-001 dosing)
For each vaccine group the percentage of subjects with SAE(s) with 95% confidence interval
All subjects
Time frame: Day 0 to Day 180 (study conclusion)
For each vaccine group the influenza-specific cellular immune responses evaluated by multi-parametric FACS analysis
All subjects
Time frame: Days 0 and 42 (21 days after the last M-001 dosing)
For each vaccine group the antibody responses to the H5 vaccine strain evaluated by hemaglutination inhibition (HI) assay
All subjects
Time frame: Days 0 and 63 (21 days after the H5N1 immunization)
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