Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age.

All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: BiondVax Pharmaceuticals ltd.
• Treatments: Vaccines

Criteria

Inclusion Criteria:

1. Males and females between ≥50 - ≤65 years old at the time expected for the first injection.

2. Eligible to receive the standard seasonal influenza vaccine according to the ministry of health guidelines.

3. Subjects who provide written informed consent to participate in the study.

4. Subjects able to adhere to the visit schedule and protocol requirements and are available to complete the study.

5. Pre-menopausal female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

6. Postmenopausal women, defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.

7. Subjects must agree to use an acceptable contraceptive method the full term of the study period (including follow up).

Exclusion Criteria:

1. Subjects who are likely, in the opinion of the investigator, to confound the results of the study or may be exposed to additional risks by participation in the study, based on medical history, vital signs, ECG, physical examination and safety lab tests.

2. Subjects with known Guillain Barré Syndrome in the past.

3. Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus (based on the assessment of the investigator) within eight months prior to first vaccination.

4. Known hypersensitivity associated with previous influenza vaccination.

5. Use of an influenza antiviral medication within 4 weeks of first vaccination.

6. Known allergy to egg protein

7. Known hypersensitivity and/or allergy to any drug or vaccine.

8. Persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.

9. History of any bleeding disorder or subjects with thrombocytopenia (since bleeding may occur following an intramuscular administration to these subjects).

10. Positive serology for Human immunodeficiency virus (HIV) , Hepatitis C Virus (HCV) antibody or HBsAg.

11. Any acute medical situation (e.g. acute infection, ongoing flu symptoms) with or without fever within 48 hours of vaccination, which is considered significant by the Investigator.

12. Pregnant or currently lactating women.

13. Subjects who participated in another interventional clinical study within 30 days prior to first dose.

14. Subjects who are non-cooperative or unwilling to sign consent form.