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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimeric-001, Adjuvanted | Experimental | 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). |
|
| PBS and TIV 15% | Active Comparator | 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). |
|
| Placebo, Adjuvanted | Placebo Comparator | 32 subjects received Adjuvanted PBS (Placebo) with an interval of 21 days. |
|
| Co-administration M-001 and TIV 15% | Experimental | 24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 15%. |
|
| Co administration of M-001 and TIV 50% | Experimental | 24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 50%. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimeric-001, 500 mcg | Biological | Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 21 days after second immunization with M-001 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular Immunogenicity | Elevated proliferation of lymphocytes following in vitro incubation with M-001. The proliferation was associated with IFN gamma secretion | 21 days after co administration of M-001 and TIV 50% |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Atsmon, MD | Clinical Research Center, Tel-Aviv Sourasky Medical Center | Principal Investigator |
| Yosef Caraco, Phd | Clinical Research Center, Hadassah Medical Center, Jerusalem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, Hadassah Medical Center | Jerusalem | Israel | ||||
| Clinical Research Center, Tel-Aviv Sourasky Medical Center |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
| Co administration of PBS and TIV 50% | Active Comparator | 24 subjects received 2 injections on the same day, one injection containing PBS and the other containing TIV 50%. |
|
| Adjuvanted PBS | Biological | Adjuvanted PBS was administered twice with an interval of 19-23 days. |
|
|
| PBS and TIV 15% | Biological | 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 and TIV 50% | Biological | 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. |
|
| 21 days post co administration of M-001 and TIV 50% |
| Tel Aviv |
| Israel |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |