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

BiondVax Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Biological: Adjuvanted Multimeric-001 500 Mcg; Biological: Multimeric-001 125 Mcg; Biological: Multimeric-001 250 Mcg; Biological: Adjuvanted Multimeric-001 250 Mcg; Biological: Adjuvanted PBS; Biological: Phosphate Buffered saline; Biological: Multimeric-001 500 Mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00877448

BVX002

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 7 patient groups, including a placebo group

Multimeric-001 250 Mcg

Experimental group

Description:

Multimeric-001 250 Mcg in PBS

Treatment:

Biological: Adjuvanted Multimeric-001 250 Mcg

Adjuvanted Multimeric-001 250 Mcg

Experimental group

Description:

250 Mcg in montanide

Treatment:

Biological: Multimeric-001 250 Mcg

Phosphate Buffered saline

Placebo Comparator group

Description:

Non-adjuvanted placebo

Treatment:

Biological: Phosphate Buffered saline

Adjuvanted PBS

Placebo Comparator group

Description:

Adjuvant was montanide

Treatment:

Biological: Adjuvanted PBS

Multimeric-001 500 Mcg

Experimental group

Description:

Multimeric-001 in PBS

Treatment:

Biological: Multimeric-001 500 Mcg

Adjuvanted Multimeric-001 500 Mcg

Experimental group

Description:

Adjuvant was montanide

Treatment:

Biological: Adjuvanted Multimeric-001 500 Mcg

Multimeric-001 125 Mcg

Experimental group

Description:

Multimeric-001 in PBS

Treatment:

Biological: Multimeric-001 125 Mcg