Back to resultsA Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
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
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring INFLUENZA, VACCINE, UNIVERSAL, SAFETY
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)
- 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
Sites / Locations
- Tasmc Crc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Multimeric-001 250 Mcg
Adjuvanted Multimeric-001 250 Mcg
Phosphate Buffered saline
Adjuvanted PBS
Multimeric-001 500 Mcg
Adjuvanted Multimeric-001 500 Mcg
Multimeric-001 125 Mcg
Arm Description
Multimeric-001 250 Mcg in PBS
250 Mcg in montanide
Non-adjuvanted placebo
Adjuvant was montanide
Multimeric-001 in PBS
Adjuvant was montanide
Multimeric-001 in PBS
Outcomes
Primary Outcome Measures
Adverse Events
Number of adverse events per cohort
Treatment-related Adverse Events
Number of treatment-related adverse events per cohort
Secondary Outcome Measures
Full Information
NCT ID
NCT00877448
First Posted
January 28, 2009
Last Updated
February 7, 2023
Sponsor
BiondVax Pharmaceuticals ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00877448
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BiondVax Pharmaceuticals ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
INFLUENZA, VACCINE, UNIVERSAL, SAFETY
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multimeric-001 250 Mcg
Arm Type
Experimental
Arm Description
Multimeric-001 250 Mcg in PBS
Arm Title
Adjuvanted Multimeric-001 250 Mcg
Arm Type
Experimental
Arm Description
250 Mcg in montanide
Arm Title
Phosphate Buffered saline
Arm Type
Placebo Comparator
Arm Description
Non-adjuvanted placebo
Arm Title
Adjuvanted PBS
Arm Type
Placebo Comparator
Arm Description
Adjuvant was montanide
Arm Title
Multimeric-001 500 Mcg
Arm Type
Experimental
Arm Description
Multimeric-001 in PBS
Arm Title
Adjuvanted Multimeric-001 500 Mcg
Arm Type
Experimental
Arm Description
Adjuvant was montanide
Arm Title
Multimeric-001 125 Mcg
Arm Type
Experimental
Arm Description
Multimeric-001 in PBS
Intervention Type
Biological
Intervention Name(s)
Adjuvanted Multimeric-001 250 Mcg
Intervention Type
Biological
Intervention Name(s)
Multimeric-001 250 Mcg
Intervention Type
Biological
Intervention Name(s)
Phosphate Buffered saline
Intervention Type
Biological
Intervention Name(s)
Adjuvanted PBS
Intervention Type
Biological
Intervention Name(s)
Adjuvanted Multimeric-001 500 Mcg
Intervention Type
Biological
Intervention Name(s)
Multimeric-001 500 Mcg
Intervention Type
Biological
Intervention Name(s)
Multimeric-001 125 Mcg
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of adverse events per cohort
Time Frame
day 0 until day 42 (termination visit)
Title
Treatment-related Adverse Events
Description
Number of treatment-related adverse events per cohort
Time Frame
Day 0 until day 42 (termination visit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob Atsmon, MD
Organizational Affiliation
Sourasky Medical Center, Tel Aviv, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tasmc Crc
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
22318394
Citation
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.
Results Reference
result
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A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
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