A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)
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
1 other identifier
interventional
63
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jun 2009
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 7, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
March 27, 2013
CompletedMarch 7, 2023
February 1, 2023
4 months
January 28, 2009
August 1, 2012
February 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (7)
Multimeric-001 250 Mcg
EXPERIMENTALMultimeric-001 250 Mcg in PBS
Adjuvanted Multimeric-001 250 Mcg
EXPERIMENTAL250 Mcg in montanide
Phosphate Buffered saline
PLACEBO COMPARATORNon-adjuvanted placebo
Adjuvanted PBS
PLACEBO COMPARATORAdjuvant was montanide
Multimeric-001 500 Mcg
EXPERIMENTALMultimeric-001 in PBS
Adjuvanted Multimeric-001 500 Mcg
EXPERIMENTALAdjuvant was montanide
Multimeric-001 125 Mcg
EXPERIMENTALMultimeric-001 in PBS
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tasmc Crc
Tel Aviv, Israel
Related Publications (1)
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.
PMID: 22318394RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tamar Ben-Yedidia, PhD
- Organization
- BiondVax Pharmaceuticals Ltd.
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Atsmon, MD
Sourasky Medical Center, Tel Aviv, Israel
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2009
First Posted
April 7, 2009
Study Start
June 1, 2009
Primary Completion
October 1, 2009
Study Completion
November 1, 2009
Last Updated
March 7, 2023
Results First Posted
March 27, 2013
Record last verified: 2023-02