Healthy
Conditions
Keywords
INFLUENZA, VACCINE, UNIVERSAL, SAFETY
Brief summary
A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.
Interventions
BIOLOGICALAdjuvanted Multimeric-001 250 Mcg
BIOLOGICALMultimeric-001 250 Mcg
BIOLOGICALPhosphate Buffered saline
BIOLOGICALAdjuvanted PBS
BIOLOGICALAdjuvanted Multimeric-001 500 Mcg
BIOLOGICALMultimeric-001 500 Mcg
BIOLOGICALMultimeric-001 125 Mcg
Sponsors
BiondVax Pharmaceuticals ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females between 18 and 55 years (inclusive) of age. * Non-smoking (by declaration) for a period of at least 6 months. * Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. * Haematology and Chemistry values within normal ranges or with no clinical significance * Subjects who provide written informed consent to participate in the study
Exclusion criteria
* Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications. * Ongoing flu symptoms or influenza * Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit. * Treatment with immune immunosuppressant drugs or other immune enhancing drugs. * Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit. * Administration of any vaccine 30 days before the screening visit. * Known history of drug or alcohol abuse. * Known history of HIV, hepatitis C or B virus (HCV or HBV) * Subjects with known Guillain Barré Syndrome in the past * 2 or more hospitalization within the last year prior to screening visit * Increased liver enzymes 2.5 times above the upper reference level * Known hypersensitivity and/or allergy to any drugs * Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator. * Subjects who participated in another clinical study within 30 days prior to study entry * Subjects who are non-cooperative or unwilling to sign consent form. * Pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | day 0 until day 42 (termination visit) | Number of adverse events per cohort |
| Treatment-related Adverse Events | Day 0 until day 42 (termination visit) | Number of treatment-related adverse events per cohort |
Countries
Israel
Participant flow
Recruitment details
Recruitment was done on a running basis after eligibility of inclusion/exclusion criteria was met and subjects were invited to clinic after screening procedures within up to 21 days before their first vaccination.
Pre-assignment details
After meeting eligibility criteria to enter the study subjects were randomized simultaneously.
Participants by arm
| Arm | Count |
|---|---|
| Multimeric-001 250 mcg in PBS Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them. | 10 |
| Adjuvanted Multimeric -001 250 mcg Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total. | 10 |
| PBS (Placebo) 0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants. | 10 |
| Adjuvanted PBS Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them. | 10 |
| Multimeric-001 in PBS 500 mcg Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days | 10 |
| Adjuvanted Multimeric-001 500 mcg Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days | 10 |
| Multimeric-001 125 mcg Multimeric-001 125 mcg in PBS administered once only. | 3 |
| Total | 63 |
Baseline characteristics
| Characteristic | Adjuvanted Multimeric -001 250 mcg | PBS (Placebo) | Adjuvanted PBS | Multimeric-001 in PBS 500 mcg | Multimeric-001 250 mcg in PBS | Adjuvanted Multimeric-001 500 mcg | Multimeric-001 125 mcg | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 3 Participants | 63 Participants |
| Age, Continuous | 25.8 years STANDARD_DEVIATION 8.8 | 25.2 years STANDARD_DEVIATION 5.3 | 26.0 years STANDARD_DEVIATION 8.4 | 29.0 years STANDARD_DEVIATION 7.4 | 24.3 years STANDARD_DEVIATION 4 | 25.2 years STANDARD_DEVIATION 4.5 | 25.7 years STANDARD_DEVIATION 3.3 | 25.9 years STANDARD_DEVIATION 6.4 |
| Region of Enrollment Israel | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 3 participants | 63 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 9 Participants | 6 Participants | 8 Participants | 10 Participants | 3 Participants | 54 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 1 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 10 | 8 / 10 | 7 / 10 | 8 / 10 | 10 / 10 | 8 / 10 | 1 / 3 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 3 |
Outcome results
Primary
Adverse Events
Number of adverse events per cohort
Time frame: day 0 until day 42 (termination visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multimeric-001 250 mcg in PBS | Adverse Events | 46 number of reported events |
| Adjuvanted Multimeric -001 250 mcg | Adverse Events | 28 number of reported events |
| PBS (Placebo) | Adverse Events | 29 number of reported events |
| Adjuvanted PBS | Adverse Events | 36 number of reported events |
| Multimeric-001 in PBS 500 mcg | Adverse Events | 42 number of reported events |
| Adjuvanted Multimeric-001 500 mcg | Adverse Events | 20 number of reported events |
| Multimeric-001 125 mcg | Adverse Events | 2 number of reported events |
Primary
Treatment-related Adverse Events
Number of treatment-related adverse events per cohort
Time frame: Day 0 until day 42 (termination visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multimeric-001 250 mcg in PBS | Treatment-related Adverse Events | 8 number of reported events |
| Adjuvanted Multimeric -001 250 mcg | Treatment-related Adverse Events | 11 number of reported events |
| PBS (Placebo) | Treatment-related Adverse Events | 3 number of reported events |
| Adjuvanted PBS | Treatment-related Adverse Events | 17 number of reported events |
| Multimeric-001 in PBS 500 mcg | Treatment-related Adverse Events | 3 number of reported events |
| Adjuvanted Multimeric-001 500 mcg | Treatment-related Adverse Events | 9 number of reported events |
| Multimeric-001 125 mcg | Treatment-related Adverse Events | 0 number of reported events |