A Double-Dose Safety Study of An Influenza Vaccine (Multi... | NCT00877448 | Trialant
NCT00877448
Sponsor
BiondVax Pharmaceuticals ltd.
Status
Completed
Last Update Posted
Mar 7, 2023Actual
Enrollment
63Actual
Phase
Phase 1Phase 2
Conditions
Healthy
Interventions
Adjuvanted Multimeric-001 250 Mcg
Multimeric-001 250 Mcg
Phosphate Buffered saline
Adjuvanted PBS
Adjuvanted Multimeric-001 500 Mcg
Multimeric-001 500 Mcg
Multimeric-001 125 Mcg
Countries
Israel
Protocol Section
Identification Module
NCT ID
NCT00877448
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BVX002
Secondary IDs
Not provided
Brief Title
A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
Official Title
A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose Safety Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
Acronym
Not provided
Organization
BiondVax Pharmaceuticals ltd.INDUSTRY
Status Module
Record Verification Date
Feb 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2009
Primary Completion Date
Oct 2009Actual
Completion Date
Nov 2009Actual
First Submitted Date
Jan 28, 2009
First Submission Date that Met QC Criteria
Apr 6, 2009
First Posted Date
Apr 7, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 1, 2012
Results First Submitted that Met QC Criteria
Feb 20, 2013
Results First Posted Date
Mar 27, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 7, 2023
Last Update Posted Date
Mar 7, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiondVax Pharmaceuticals ltd.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Healthy
Keywords
INFLUENZA
VACCINE
UNIVERSAL
SAFETY
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
63Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Multimeric-001 250 Mcg
Experimental
Multimeric-001 250 Mcg in PBS
Biological: Adjuvanted Multimeric-001 250 Mcg
Adjuvanted Multimeric-001 250 Mcg
Experimental
250 Mcg in montanide
Biological: Multimeric-001 250 Mcg
Phosphate Buffered saline
Placebo Comparator
Non-adjuvanted placebo
Biological: Phosphate Buffered saline
Adjuvanted PBS
Placebo Comparator
Adjuvant was montanide
Biological: Adjuvanted PBS
Multimeric-001 500 Mcg
Experimental
Multimeric-001 in PBS
Biological: Multimeric-001 500 Mcg
Adjuvanted Multimeric-001 500 Mcg
Experimental
Adjuvant was montanide
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Adjuvanted Multimeric-001 250 Mcg
Biological
Multimeric-001 250 Mcg
Multimeric-001 250 Mcg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Adverse Events
Number of adverse events per cohort
day 0 until day 42 (termination visit)
Treatment-related Adverse Events
Number of treatment-related adverse events per cohort
Day 0 until day 42 (termination visit)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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)
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
Atsmon J, Kate-Ilovitz E, Shaikevich D, Singer Y, Volokhov I, Haim KY, Ben-Yedidia T. Safety and immunogenicity of multimeric-001--a novel universal influenza vaccine. J Clin Immunol. 2012 Jun;32(3):595-603. doi: 10.1007/s10875-011-9632-5. Epub 2012 Feb 9.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
After meeting eligibility criteria to enter the study subjects were randomized simultaneously.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Multimeric-001 250 mcg in PBS
Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
FG001
Adjuvanted Multimeric -001 250 mcg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
Biological: Adjuvanted Multimeric-001 500 Mcg
Multimeric-001 125 Mcg
Experimental
Multimeric-001 in PBS
Biological: Multimeric-001 125 Mcg
Biological
Adjuvanted Multimeric-001 250 Mcg
Phosphate Buffered saline
Biological
Phosphate Buffered saline
Adjuvanted PBS
Biological
Adjuvanted PBS
Adjuvanted Multimeric-001 500 Mcg
Biological
Adjuvanted Multimeric-001 500 Mcg
Multimeric-001 500 Mcg
Biological
Multimeric-001 500 Mcg
Multimeric-001 125 Mcg
Biological
Multimeric-001 125 Mcg
Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
FG002
PBS (Placebo)
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
FG003
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.
FG004
Multimeric-001 in PBS 500 mcg
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
FG005
Adjuvanted Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
FG006
Multimeric-001 125 mcg
Multimeric-001 125 mcg in PBS administered once only.
FG00010 subjects
FG00110 subjects
FG00210 subjects
FG00310 subjects
FG00410 subjects
FG00510 subjects
FG0063 subjects
COMPLETED
FG00010 subjects
FG0019 subjects
FG00210 subjects
FG0039 subjects
FG00410 subjects
FG0059 subjects
FG0063 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Multimeric-001 250 mcg in PBS
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
BG001
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.
BG002
PBS (Placebo)
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
BG003
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.
BG004
Multimeric-001 in PBS 500 mcg
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
BG005
Adjuvanted Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
BG006
Multimeric-001 125 mcg
Multimeric-001 125 mcg in PBS administered once only.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00010
BG00110
BG00210
BG00310
BG00410
BG00510
BG0063
BG00763
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00024.3± 4.0
BG00125.8± 8.8
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0008
BG00110
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Israel
Title
Measurements
BG00010
BG00110
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Adverse Events
Number of adverse events per cohort
Posted
Number
number of reported events
day 0 until day 42 (termination visit)
ID
Title
Description
OG000
Multimeric-001 250 mcg in PBS
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
OG001
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.
OG002
PBS (Placebo)
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
OG003
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.
OG004
Multimeric-001 in PBS 500 mcg
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
OG005
Adjuvanted Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
OG006
Multimeric-001 125 mcg
Multimeric-001 125 mcg in PBS administered once only.
Units
Counts
Participants
OG00010
OG00110
OG00210
OG003
Title
Denominators
Categories
Title
Measurements
OG00046
OG00128
OG00229
OG003
Primary
Treatment-related Adverse Events
Number of treatment-related adverse events per cohort
Posted
Number
number of reported events
Day 0 until day 42 (termination visit)
ID
Title
Description
OG000
Multimeric-001 250 mcg in PBS
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
OG001
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.
OG002
PBS (Placebo)
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
OG003
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.
OG004
Multimeric-001 in PBS 500 mcg
Time Frame
day 0 until day 42 (termination visit)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Multimeric-001 250 mcg in PBS
Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
0
10
10
10
EG001
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.
0
10
8
10
EG002
PBS (Placebo)
0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
0
10
7
10
EG003
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.
0
10
8
10
EG004
Multimeric-001 in PBS 500 mcg
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
0
10
10
10
EG005
Adjuvanted Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
0
10
8
10
EG006
Multimeric-001 125 mcg
Multimeric-001 125 mcg in PBS administered once only.
0
3
1
3
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
General disorders
General disorders
MedDRA
Non-systematic Assessment
EG00011 events6 affected10 at risk
EG0017 events3 affected10 at risk
EG0021 events1 affected10 at risk
EG00313 events5 affected10 at risk
EG0049 events4 affected10 at risk
EG00512 events6 affected10 at risk
EG0060 events0 affected3 at risk
Blood and lymphatic system disorders
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0002 events2 affected10 at risk
EG0012 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Gastrointestinal disorders
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0007 events3 affected10 at risk
EG00110 events3 affected10 at risk
EG00210 events3 affected10 at risk
EG003
Infections and infestations
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 events2 affected10 at risk
EG0013 events3 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0022 events1 affected10 at risk
EG003
Investigations
Investigations
MedDRA
Non-systematic Assessment
EG0006 events4 affected10 at risk
EG0012 events2 affected10 at risk
EG0025 events3 affected10 at risk
EG003
Metabolism and Nutrition disorders
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 events1 affected10 at risk
EG0012 events2 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Musculosceletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0006 events5 affected10 at risk
EG0012 events2 affected10 at risk
EG0020 events0 affected10 at risk
EG003
Nervous system disorders
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0006 events5 affected10 at risk
EG0012 events2 affected10 at risk
EG0023 events2 affected10 at risk
EG003
Renal and Urinary disorders
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0005 events3 affected10 at risk
EG0014 events2 affected10 at risk
EG0024 events3 affected10 at risk
EG003
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0005 events3 affected10 at risk
EG0013 events2 affected10 at risk
EG0024 events3 affected10 at risk
EG003
Skin and Subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0002 events1 affected10 at risk
EG0011 events1 affected10 at risk
EG0021 events1 affected10 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
LTE60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Tamar Ben-Yedidia, PhD
BiondVax Pharmaceuticals Ltd.
972-8-9302529
benyedidia@BiondVax.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
0
BG0040
BG0050
BG0060
BG0070
Between 18 and 65 years
BG00010
BG00110
BG00210
BG00310
BG00410
BG00510
BG0063
BG00763
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
25.2
± 5.3
BG00326.0± 8.4
BG00429.0± 7.4
BG00525.2± 4.5
BG00625.7± 3.3
BG00725.9± 6.4
8
BG0039
BG0046
BG00510
BG0063
BG00754
Male
BG0002
BG0010
BG0022
BG0031
BG0044
BG0050
BG0060
BG0079
10
BG00310
BG00410
BG00510
BG0063
BG00763
10
OG00410
OG00510
OG0063
36
OG00442
OG00520
OG0062
Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
OG005
Adjuvanted Multimeric-001 500 mcg
Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
OG006
Multimeric-001 125 mcg
Multimeric-001 125 mcg in PBS administered once only.