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

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

M-001

Saline

About this trial

This is an interventional treatment trial for Influenza focused on measuring Influenza, vaccine, universal, M-001, Multimeric-001, Flu

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Jagiellońskie Centrum Innowacji Sp.z o.o.
Jagiellońskie Centrum Innowacji Sp.z o.o.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

M-001

Saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Number of Participants With Culture-confirmed Influenza Incidence

Occurrence of 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.

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

Assessed by reduction of severity of either qRT-PCR or culture-confirmed influenza illness by the reduction due to M-001 in the average number of days with respiratory or systemic symptoms during the first laboratory-confirmed influenza illness episode.

Number of Participants With Influenza-like Illness Symptoms

Assessment of number of participants having ILI symptoms in the experimental or control group

Full Information

NCT ID

NCT03450915

First Posted

February 8, 2018

Last Updated

September 13, 2021

Sponsor

BiondVax Pharmaceuticals ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03450915

Brief Title

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

Official Title

A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

July 2, 2020 (Actual)

Study Completion Date

October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

BiondVax Pharmaceuticals ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enroll a total of approximately 12,460 participants over two years. Participants will be immunized twice with the M-001 influenza vaccine candidate or placebo. Influenza incidence and illness severity will be evaluated throughout the follow-up period of up to two years. Participants will be 50 years and older, with at least half over 65 years of age. The trial is expected to take place in eastern European countries and begin prior to the 2018/19 Northern Hemisphere flu season.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

12460 (Actual)

8. Arms, Groups, and Interventions

Arm Title

M-001

Arm Type

Experimental

Arm Description

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

Arm Title

Saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

M-001

Other Intervention Name(s)

Multimeric-001

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Saline

Intervention Description

0.9% sodium chloride (NaCl)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Title

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

Description

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

Time Frame

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 Outcome Measure Information:

Title

Number of Participants With Culture-confirmed Influenza Incidence

Description

Occurrence of 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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

Number of Participants With Influenza-like Illness Symptoms

Description

Assessment of number of participants having ILI symptoms in the experimental or control group

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tamar Ben-Yedidia, PhD

Organizational Affiliation

BiondVax Pharmaceuticals ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Jagiellońskie Centrum Innowacji Sp.z o.o.

City

Kraków

State/Province

Ul. Bobrzyńskiego 14,

ZIP/Postal Code

30-348

Country

Poland

Facility Name

Jagiellońskie Centrum Innowacji Sp.z o.o.

City

Kraków

ZIP/Postal Code

30348

Country

Poland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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