Healthy Clinical Trial
Official title:
A Phase II Multicenter, Randomized, Placebo Controlled Study to Assess the Safety and Immunogenicity of an IM Influenza Vaccine (Multimeric-001) Followed by Administration of TIV to Elderly Volunteers.
"Multimeric-001" (M-001) has been recently developed, containing 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 seasonal influenza vaccine in the
elderly population. The current clinical study was designed to assess M-001's standalone and
priming action in subjects over 65 years old.
This is a second Phase II study comprising 120 participants. Eligible subjects were
randomized to receive to receive either two sequential non-adjuvanted or a single
non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment),
or one placebo (saline) injection, before receiving the TIV.
This was a two-center, randomized, placebo-controlled study. 120 subjects were randomized 1:1:1:1 into four groups to receive either two sequential non-adjuvanted or a single non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment), or one placebo (saline) injection, before receiving the TIV. Due to visual differences between placebo and treatment the study was partially blinded. Hemagglutinin inhibition (HAI) was evaluated at baseline and 3 weeks after standard trivalent inactivated influenza vaccine (TIV) vaccination as a measure of M-001's efficacy. Cell mediated immune (CMI) responses were also evaluated in some of the subjects who received non-adjuvanted and adjuvanted M-001 vaccinations. The subjects were monitored for safety throughout the study. ;
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