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

NCT02293317 | Completed Phase 2

• 1 other identifier: BVX-006
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

Influenza Prime universal vaccine M-001 Multimeric

Outcome Measures

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.

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

Secondary Outcomes (2)

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

  Day 84 (21 days after TIV injection)

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

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

Study Arms (3)

M-001 0.5mg & TIV

EXPERIMENTAL

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

M-001 1.0mg & TIV

EXPERIMENTAL

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 & TIV

PLACEBO COMPARATOR

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

Drug: TIV; Other: Saline

Interventions

M-001 BIOLOGICAL

A recombinant epitope based universal vaccine against seasonal and pandemic influenza

Also known as: Multimeric-001

M-001 0.5mg & TIV; M-001 1.0mg & TIV

TIV DRUG

HA based seasonal influenza vaccine, for 2014/15 seson

M-001 0.5mg & TIV; M-001 1.0mg & TIV; Placebo & TIV

Saline OTHER

Placebo

Placebo & TIV

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between ≥50 - ≤65 years old at the time expected for the first injection.
• Eligible to receive the standard seasonal influenza vaccine according to the ministry of health guidelines.
• Subjects who provide written informed consent to participate in the study.
• Subjects able to adhere to the visit schedule and protocol requirements and are available to complete the study.
• 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).
• Postmenopausal women, defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
• Subjects must agree to use an acceptable contraceptive method the full term of the study period (including follow up).

You may not qualify if:

• 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.
• Subjects with known Guillain Barré Syndrome in the past.
• 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.
• Known hypersensitivity associated with previous influenza vaccination.
• Use of an influenza antiviral medication within 4 weeks of first vaccination.
• Known allergy to egg protein
• Known hypersensitivity and/or allergy to any drug or vaccine.
• Persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
• History of any bleeding disorder or subjects with thrombocytopenia (since bleeding may occur following an intramuscular administration to these subjects).
• Positive serology for Human immunodeficiency virus (HIV) , Hepatitis C Virus (HCV) antibody or HBsAg.
• 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.
• Pregnant or currently lactating women.
• Subjects who participated in another interventional clinical study within 30 days prior to first dose.
• Subjects who are non-cooperative or unwilling to sign consent form.

Sponsors & Collaborators

• BiondVax Pharmaceuticals ltd.: lead

Study Sites (1)

Clinical Research Center, Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

PN M001; Sodium Chloride

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tamar Ben Yedidia, PhD

  BiondVax Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: February 23, 2016

Record last verified: 2014-11

Locations

IL (1)