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

Influenza Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450915
• Other study ID #: BVX-010
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2018
• Est. completion date: October 23, 2020

Study information

• Verified date: September 2021
• Source: BiondVax Pharmaceuticals ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12460
• Est. completion date: October 23, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Able to comply with the trial procedures and be available for all study visits.

3. 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).

4. 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)

5. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.

Exclusion Criteria:

1. History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.

2. Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).

3. 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

4. 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.

5. An acute illness, including an axillary temperature greater than 38 Celsius (38ºC), occurred within 1 week before first vaccination

6. Positive positive urine pregnancy test prior to vaccination or women who are breastfeeding.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• M-001
A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
• Saline
0.9% sodium chloride (NaCl)

Locations

Country	Name	City	State
Poland	Jagiellonskie Centrum Innowacji Sp.z o.o.	Kraków	Ul. Bobrzynskiego 14,
Poland	Jagiellonskie Centrum Innowacji Sp.z o.o.	Kraków

Sponsors (1)

Lead Sponsor	Collaborator
BiondVax Pharmaceuticals ltd.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Secondary	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.	From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year
Secondary	Number of Participants With Influenza-like Illness Symptoms	Assessment of number of participants having ILI symptoms in the experimental or control group	From Day 14 post-second vaccination day to end of influenza season, an average of 4 months per participant per year