Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age.
All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.
Subjects will undergo screening procedures within 30 days prior to first vaccination which will include medical history, vital signs, ECG, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and circulating Interferon gamma (IFN-g). They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (± 15 min) at which time they will be released from the Clinical research center.
The second treatment will take place 21 (±2) days after the first vaccination. Procedures will be the same as that of Visit 2 Additional two follow-up visits will take place at approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the second vaccination. Procedures will be the same as that of Visit 2 21 days later, each subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.
A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M-001 0.5mg & TIV | Experimental | M-001 (0.5mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) |
|
| M-001 1.0mg & TIV | Experimental | M-001 (1.0mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) |
|
| Placebo & TIV | Placebo Comparator | 0.3ml Saline administered Intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M-001 | Biological | A recombinant epitope based universal vaccine against seasonal and pandemic influenza |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events in treatment vs control group | Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be measured in the experimental and control group, both local and systemic adverse events will be followed. | 3 months (from first visit to termination visit for each subject) |
| Measure | Description | Time Frame |
|---|---|---|
| Immunity induced by priming and boosting, measured by HAI (Hemagglutination Inhibition) | To characterize humoral immunity, Hemagglutination Inhibition (HAI) test for anti influenza antibodies to TIV strains will be measured after boosting with TIV, proportion of participants achieving seroconversion in the groups primed with M-001 and boosted with TIV, will be compared to participants given TIV alone. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tamar Ben Yedidia, PhD | BiondVax Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C502600 | PN M001 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| TIV | Drug | HA based seasonal influenza vaccine, for 2014/15 seson |
|
| Saline | Other | Placebo |
|
| Day 84 (21 days after TIV injection) |
| Number of participants with cell mediated immune response in treatment vs control group | To characterize the cell mediated immune response, Fluorescence activated cell sorter (FACS) analysis for CD4/CD8 lymphocytes will be performed after 3 immunizations with M-001 as compared to the control group (injected 3 times with saline) | Day 63 (21 days after immunization with M-001) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D017670 |
| Sodium Compounds |