Healthy Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Active-controlled Phase 2b Trial [Part of EU-funded UNISEC Project] to Assess the Immunogenicity & Safety of a BiondVax's Influenza Vaccine (M-001) Followed by H5N1 Vaccine in Healthy Adults
"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. ;
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