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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: Adjuvanted Multimeric-001 500 Mcg; Biological: Multimeric-001 125 Mcg; Biological: Multimeric-001 250 Mcg; Biological: Adjuvanted PBS; Biological: Adjuvanted Multimeric-001 250 Mcg; Biological: Phosphate Buffered saline; Biological: Multimeric-001 500 Mcg

• Registration Number: NCT00877448
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-04-06
• Study First Posted: 2009-04-07
• Study Start: 2009-06
• Primary Completion: 2009-10
• Study Completion: 2009-11
• Results First Submitted: 2012-08-01
• Results First Submitted QC: 2013-02-20
• Results First Posted: 2013-03-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvanted Multimeric-001 500 Mcg	Adjuvanted Multimeric-001 500 Mcg	Adjuvant was montanide
Multimeric-001 125 Mcg	Multimeric-001 125 Mcg	Multimeric-001 in PBS
Adjuvanted Multimeric-001 250 Mcg	Multimeric-001 250 Mcg	250 Mcg in montanide
Adjuvanted PBS	Adjuvanted PBS	Adjuvant was montanide
Multimeric-001 250 Mcg	Adjuvanted Multimeric-001 250 Mcg	Multimeric-001 250 Mcg in PBS
Phosphate Buffered saline	Phosphate Buffered saline	Non-adjuvanted placebo
Multimeric-001 500 Mcg	Multimeric-001 500 Mcg	Multimeric-001 in PBS

Primary Outcome Measures

Name	Time	Method
Treatment-related Adverse Events	Day 0 until day 42 (termination visit)	Number of treatment-related adverse events per cohort
Adverse Events	day 0 until day 42 (termination visit)	Number of adverse events per cohort

Trial Locations

Locations (1)

Tasmc Crc; 🇮🇱 Tel Aviv, Israel