A Phase 2 interventional study of Multimeric-001, 500 mcg and Adjuvanted PBS in Influenza, sponsored by BiondVax Pharmaceuticals ltd.. Completed at 2 sites in Israel. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-31.
Sponsored by BiondVax Pharmaceuticals ltd. · Phase 2, Interventional, and Treatment
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
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 200 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →BiondVax Pharmaceuticals ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
64 subjects received 2 injections of Adjuvanted Multimeric-001, 500 mcg with an interval of 21 days and then 60 days later were further immunized with a 15% dose of commercial seasonal trivalent vaccine (season 2011).
Biological: Multimeric-001, 500 mcg
32 subjects received 2 injections of PBS (Phosphate Buffered Saline) with an interval of 21 days and then were further immunized 60 days later with a 15% dose of commercial seasonal trivalent vaccine (season 2011).
Biological: PBS and TIV 15%
32 subjects received Adjuvanted PBS (Placebo) with an interval of 21 days.
Biological: Adjuvanted PBS
24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 15%.
Biological: Multimeric-001, 500 mcg
24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 50%.
Biological: Multimeric-001, 500 mcg
24 subjects received 2 injections on the same day, one injection containing PBS and the other containing TIV 50%.
Biological: PBS and TIV 50%
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.
Also known as: placebo
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.
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.
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%
Cellular Immunogenicity
Elevated proliferation of lymphocytes following in vitro incubation with M-001. The proliferation was associated with IFN gamma secretion
Time frame: 21 days after co administration of M-001 and TIV 50%
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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BiondVax Pharmaceuticals ltd.