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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BiondVax Pharmaceuticals ltd.
ClinicalTrials.gov Identifier:
NCT00877448
First received: January 28, 2009
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by BiondVax Pharmaceuticals ltd.:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: day 0 until day 42 (termination visit) ] [ Designated as safety issue: Yes ]
    Number of adverse events per cohort

  • Treatment-related Adverse Events [ Time Frame: Day 0 until day 42 (termination visit) ] [ Designated as safety issue: Yes ]
    Number of treatment-related adverse events per cohort


Enrollment: 63
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00877448

Locations
Israel
Tasmc Crc
Tel Aviv, Israel
Sponsors and Collaborators
BiondVax Pharmaceuticals ltd.
Investigators
Principal Investigator: Jacob Atsmon, MD Sourasky Medical Center, Tel Aviv, Israel
  More Information

Publications:
Responsible Party: BiondVax Pharmaceuticals ltd.
ClinicalTrials.gov Identifier: NCT00877448     History of Changes
Other Study ID Numbers: BVX002
Study First Received: January 28, 2009
Results First Received: August 1, 2012
Last Updated: February 20, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by BiondVax Pharmaceuticals ltd.:
INFLUENZA
VACCINE
UNIVERSAL
SAFETY

ClinicalTrials.gov processed this record on September 18, 2014