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CompletedNCT02293317BVX006Updated Feb 23, 2016

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

A Phase 2 interventional study of M-001 and TIV in Influenza, sponsored by BiondVax Pharmaceuticals ltd.. Completed at 1 site in Israel. Open to participants aged 50 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-23.

Sponsored by BiondVax Pharmaceuticals ltd. · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Subjects will undergo screening procedures within 30 days prior to first vaccination which will include medical history, vital signs, ECG, physical examination and safety blood and urine lab tests.

On the first treatment visit, eligible subjects will undergo pre-dose physical examination and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and circulating Interferon gamma (IFN-g). They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (± 15 min) at which time they will be released from the Clinical research center.

The second treatment will take place 21 (±2) days after the first vaccination. Procedures will be the same as that of Visit 2 Additional two follow-up visits will take place at approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the second vaccination. Procedures will be the same as that of Visit 2 21 days later, each subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.

A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.

02

Conditions studied

  • Influenza

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Keywords

  • Influenza Prime universal vaccine M-001 Multimeric
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 37 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

BiondVax Pharmaceuticals ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    M-001 0.5mg & TIV

    M-001 (0.5mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV)

    Biological: M-001 · Drug: TIV

  • Experimental
    M-001 1.0mg & TIV

    M-001 (1.0mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV)

    Biological: M-001 · Drug: TIV

  • Placebo comparator
    Placebo & TIV

    0.3ml Saline administered Intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV)

    Drug: TIV · Other: Saline

Interventions

  • BiologicalM-001

    A recombinant epitope based universal vaccine against seasonal and pandemic influenza

    Also known as: Multimeric-001

  • DrugTIV

    HA based seasonal influenza vaccine, for 2014/15 seson

  • OtherSaline

    Placebo

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events in treatment vs control group

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be measured in the experimental and control group, both local and systemic adverse events will be followed.

    Time frame: 3 months (from first visit to termination visit for each subject)

Secondary outcomes

  1. Immunity induced by priming and boosting, measured by HAI (Hemagglutination Inhibition)

    To characterize humoral immunity, Hemagglutination Inhibition (HAI) test for anti influenza antibodies to TIV strains will be measured after boosting with TIV, proportion of participants achieving seroconversion in the groups primed with M-001 and boosted with TIV, will be compared to participants given TIV alone.

    Time frame: Day 84 (21 days after TIV injection)

  2. Number of participants with cell mediated immune response in treatment vs control group

    To characterize the cell mediated immune response, Fluorescence activated cell sorter (FACS) analysis for CD4/CD8 lymphocytes will be performed after 3 immunizations with M-001 as compared to the control group (injected 3 times with saline)

    Time frame: Day 63 (21 days after immunization with M-001)

07

Study locations

1 site
  • Clinical Research Center, Tel-Aviv Sourasky Medical Center
    Tel-Aviv, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02293317
Lead sponsor
BiondVax Pharmaceuticals ltd.
Responsible party
Sponsor
First posted
Nov 18, 2014
Start date
Nov 2014
Primary completion
Mar 2015
Completion
Jun 2015
Last update
Feb 23, 2016

Study contacts

Tamar Ben Yedidia, PhD
study chair · BiondVax Pharmaceuticals

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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