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

February 7, 2023 updated by: BiondVax Pharmaceuticals ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel
        • Tasmc Crc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: day 0 until day 42 (termination visit)
Number of adverse events per cohort
day 0 until day 42 (termination visit)
Treatment-related Adverse Events
Time Frame: Day 0 until day 42 (termination visit)
Number of treatment-related adverse events per cohort
Day 0 until day 42 (termination visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BiondVax Pharmaceuticals ltd.

Investigators

  • Principal Investigator: Jacob Atsmon, MD, Sourasky Medical Center, Tel Aviv, Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

January 28, 2009

First Submitted That Met QC Criteria

April 6, 2009

First Posted (Estimate)

April 7, 2009

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BVX002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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