Overview

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.