A Pivotal Trial to Assess the Safety and Clinical Efficacy of the M-001 as a Standalone Universal Flu Vaccine

NCT03450915 | Completed Phase 3 Results DMC

• 1 other identifier: BVX-010
• Study Type: interventional
• Target: 12,460
• Locations: 1 country
• Sites: 2

Brief Summary

The pivotal Phase 3 trial plans to enroll a total of approximately 12,460 participants aged 50+ over two years. Participants will be immunized twice with the M-001 universal influenza vaccine candidate or placebo and then followed for up to 2 seasons. The trial will evaluate the number of influenza cases in each group and the severity of illness during the follow up period.

Conditions

Influenza

Keywords

Influenza; vaccine; universal; M-001; Multimeric-001; Flu

Outcome Measures

Primary Outcomes (2)

• Number of Participants With qRT-PCR or Culture-confirmed Influenza-like Illness

  Prevention of influenza disease by comparing the occurrence of either qRT-PCR or culture confirmed influenza in the M-001 experimental group vs. placebo caused by any influenza A or B virus in association with a protocol defined Influenza Like Illness.

  From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year

• Number of Participants With One or More Serious Adverse Events, New Onset Chronic Illness, and Non-solicited Adverse Events

  Number of participants with one or more Serious Adverse Events, New Onset Chronic illness, and Non-solicited Adverse Events assessed during one flu season per participant

  From Day 0 to end of study completion by participant which coincides with end of flu season in the respective year, an average of 4 months per participant per year

Secondary Outcomes (3)

• Number of Participants With Culture-confirmed Influenza Incidence

  From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year

• Number of Participants With Reduction of Severity of qRT-PCR or Culture-confirmed Influenza

  From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year

• Number of Participants With Influenza-like Illness Symptoms

  From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year

Study Arms (2)

M-001

EXPERIMENTAL

Participants will be vaccinated with 1mg dose of M-001 twice: Once at Day 0, and once at Day 21.

Biological: M-001

Saline

PLACEBO COMPARATOR

Participants will be vaccinated with saline twice: Once at Day 0, and once at Day 21.

Biological: Saline

Interventions

M-001 BIOLOGICAL

A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.

Also known as: Multimeric-001

M-001

Saline BIOLOGICAL

0.9% sodium chloride (NaCl)

Saline

Eligibility Criteria

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

You may qualify if:

• Male and female subjects 50 years of age (inclusive) or older, mentally competent, willing and able to give the written informed consent prior to study entry
• Able to comply with the trial procedures and be available for all study visits.
• Medically stable. (Subjects may have underlying chronic conditions such as hypertension, diabetes, ischemic heart disease, or hypothyroidism, as long as their symptoms/signs are controlled. If they are on medication for a condition, the medication dose must have been stable for at least 3 months preceding vaccination).
• Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice adequate contraception (barrier or hormone methods or intra uterine device (IUD) for women and a condom for men) throughout the study treatment and for at least up to day 51 (for female) and day 111 (for male) of the trial (i.e. 30 (for female) and 90 (for male) days after the last dose of the IMP)
• Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

You may not qualify if:

• History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
• Receipt of: a) Immunosuppressive drugs: i) systemic glucocorticoids \>/= 10 mg prednisone per day ii) cytotoxic drugs b) Investigational drugs within 30 days before, or planned during, the study c) Blood products within 3 months before, or planned during, the study d) Influenza vaccine within 6 months before the study) Other vaccines within 30 days before, or planned during, the study
• Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, or congestive heart failure, as judged by the PI.
• An acute illness, including an axillary temperature greater than 38 Celsius (38ºC), occurred within 1 week before first vaccination
• Positive positive urine pregnancy test prior to vaccination or women who are breastfeeding.

Sponsors & Collaborators

• BiondVax Pharmaceuticals ltd.: lead

Study Sites (2)

Jagiellońskie Centrum Innowacji Sp.z o.o.

Krakow, Ul. Bobrzyńskiego 14,, 30-348, Poland

Location

Jagiellońskie Centrum Innowacji Sp.z o.o.

Krakow, 30348, Poland

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

Results Point of Contact

• Title: Chief Scientific Officer & Clinical Management
• Organization: BiondVax Pharmaceuticals ltd.

benyedidia@BiondVax.com

+97289302529

Study Officials

• Tamar Ben-Yedidia, PhD

  BiondVax Pharmaceuticals ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties are blinded except for the person who prepares the syringe for injection. The M-001 is cloudy white and its appearance is different from the transparent saline that is used for placebo. The person prepares the syringe with an opaque sticker that fully covers the syringe contents. People administering the syringe are not involved or present during syringe preparation, and are thus fully blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental group: 2 immunizations with M-001 Control group: 2 injection of saline (placebo)

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: March 1, 2018
• Study Start: August 1, 2018
• Primary Completion: July 2, 2020
• Study Completion: October 23, 2020
• Last Updated: October 5, 2021
• Results First Posted: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)