This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.
This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled study comprising 200 participants. Eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg - 64 subjects. Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS (Placebo)twice - 32 subjects. Participants from administrations A and B will be further immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81. Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose - 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with 50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once with 50% of TIV dose - 24 subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days.
Adjuvanted PBS was administered twice with an interval of 19-23 days.
PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered.
Clinical Research Center, Hadassah Medical Center
Jerusalem, Israel
Clinical Research Center, Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events possible/probably related to the study drug in each group were similar in the experimental and control groups.
Time frame: From day 0 until day 221
Anti Multimeric-001 antibodies
Direct Elisa assay to test the titer of human antibodies that recognize the Multimeric-001 protein. Humoral immunity was manifested 21 and 60 days post immunization by significantly elevated anti-M-001 IgG levels among subjects administered twice with adjuvanted M-001
Time frame: 21 days after second immunization with M-001
Hemagglutination Inhibition (HAI) test for anti influenza antibodies
The serum is tested for its ability to adhere to influenza virus and thus inhibit the Hemagglutination reaction. Adjuvanted M-001 co-administered with partial dose of TIV (Vaxigrip, 50%) was effective in enhancing immunity to influenza-related antigens, as manifested by increased HAI antibody responses toward viruses contained in the TIV as well as toward non-TIV virus strains.
Time frame: 21 days post co administration of M-001 and TIV 50%
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PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered.