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

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.

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