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A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877448
Recruitment Status : Completed
First Posted : April 7, 2009
Results First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Information provided by (Responsible Party):
BiondVax Pharmaceuticals ltd.

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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Adjuvanted Multimeric-001 250 Mcg Biological: Multimeric-001 250 Mcg Biological: Phosphate Buffered saline Biological: Adjuvanted PBS Biological: Adjuvanted Multimeric-001 500 Mcg Biological: Multimeric-001 500 Mcg Biological: Multimeric-001 125 Mcg Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : June 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Multimeric-001 250 Mcg
Multimeric-001 250 Mcg in PBS
Biological: Adjuvanted Multimeric-001 250 Mcg
Experimental: Adjuvanted Multimeric-001 250 Mcg
250 Mcg in montanide
Biological: Multimeric-001 250 Mcg
Placebo Comparator: Phosphate Buffered saline
Non-adjuvanted placebo
Biological: Phosphate Buffered saline
Placebo Comparator: Adjuvanted PBS
Adjuvant was montanide
Biological: Adjuvanted PBS
Experimental: Multimeric-001 500 Mcg
Multimeric-001 in PBS
Biological: Multimeric-001 500 Mcg
Experimental: Adjuvanted Multimeric-001 500 Mcg
Adjuvant was montanide
Biological: Adjuvanted Multimeric-001 500 Mcg
Experimental: Multimeric-001 125 Mcg
Multimeric-001 in PBS
Biological: Multimeric-001 125 Mcg

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: day 0 until day 42 (termination visit) ]
    Number of adverse events per cohort

  2. Treatment-related Adverse Events [ Time Frame: Day 0 until day 42 (termination visit) ]
    Number of treatment-related adverse events per cohort

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877448

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Tasmc Crc
Tel Aviv, Israel
Sponsors and Collaborators
BiondVax Pharmaceuticals ltd.
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Principal Investigator: Jacob Atsmon, MD Sourasky Medical Center, Tel Aviv, Israel
Publications of Results:
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Responsible Party: BiondVax Pharmaceuticals ltd. Identifier: NCT00877448    
Other Study ID Numbers: BVX002
First Posted: April 7, 2009    Key Record Dates
Results First Posted: March 27, 2013
Last Update Posted: March 27, 2013
Last Verified: February 2013
Keywords provided by BiondVax Pharmaceuticals ltd.:
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases