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This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age with a dose escalation.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
This is a single-site, randomized, double-blind, placebo-controlled study of Uniflu in fifty four (54) volunteers 18-60 years of age.
All subjects will receive an intramuscular (IM) injection twice,with a 21 days interval between treatments.
Subjects will undergo screening procedures within 6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination,vital signs, ECG, a blood sample will be drawn for circulating IgE. They receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle. The subjects will remain under medical supervision for 72 hrs, after that time they will be released from the Clinical research center.
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as on the first treatment visit.
Follow-up visits take place at 4th, 5th, 6th, 14th, 35th days. A Study Termination visit will take place at 42nd day of research. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LD Universal Influenza Vaccine Uniflu | Active Comparator | low dose of Uniflu vaccine 0.5 ml (20 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals |
|
| HD Universal Influenza Vaccine Uniflu | Active Comparator | high dose of Uniflu vaccine 0.5 ml (40 mkg of recombinant protein HBc-4M2eh) administrated intramuscularly 2 times at 21 days intervals |
|
| Placebo | Placebo Comparator | saline 0.5 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LD Universal Influenza Vaccine Uniflu | Biological | low dose Universal Influenza Vaccine Uniflu |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events in treatment vs control group | Estimation the quantity of adverse events in treatment group vs control group | 42 days (from first visit to termination visit for each subject) |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Immunogenicity | Determination of antibody levels of IgG to M2e protein measured by IFA vs. baseline values | Time Frame: at days 1, 21, 42. |
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Inclusion Criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Julia M Savateeva, PhD | VA Pharma Limited Liability Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Influenza | Saint Petersburg | Sankt-Peterburg | 197376 | Russia |
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Subjects will undergo screening procedures within 2-6 days prior to first vaccination which will include medical history, vital signs, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination, ECG, vital signs, and a blood sample for circulating IgE. They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of non dominant arm. The subjects will remain under medical supervision for 72 hrs at which time they will be released from the Clinical research center.
The second treatment will take place 21 days after the first vaccination. Procedures will be the same as that of Visit 1 Additional follow-up visits will take place at 4-7th,14th,24-27th and 42nd days. Blood and urine samples will be collected for safety.
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| HD Universal Influenza Vaccine Uniflu | Biological | High dose Universal Influenza Vaccine Uniflu |
|
| Placebo | Biological | Placebo saline |
|