Assess the Safety and Immunogenicity of M-001 as A Standalone Influenza Vaccine and as A H5N1 Vaccine Primer in Adults

NCT02691130 | Completed Phase 2 DMC

• 1 other identifier: BVX-007
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

"Multimeric-001" (M-001) contains conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to pandemic influenza vaccine in the adult population. The current clinical study was designed to assess M-001's standalone and priming action in subjects aged 18-60 years old. This is a Phase IIb study comprising 222 participants. Eligible subjects were randomized to receive two sequential intramuscular injection of 0.5mg or 1.0mg M-001 (treatment), or two placebo (saline) injection, before receiving the sub optimal dose of H5N1 pandemic vaccine.

Conditions

Influenza; Healthy

Keywords

influenza; vaccine; universal; peptide; prime; boost; HAI; CMI; UNISEC

Outcome Measures

Primary Outcomes (3)

• For each vaccine group the incidence rate of subjects with solicited AE(s) with 95% confidence interval

  All subjects

  Day 0 to Day 42 (21 days after the last M-001 dosing)

• For each vaccine group the percentage of subjects with SAE(s) with 95% confidence interval

  All subjects

  Day 0 to Day 180 (study conclusion)

• For each vaccine group the influenza-specific cellular immune responses evaluated by multi-parametric FACS analysis

  All subjects

  Days 0 and 42 (21 days after the last M-001 dosing)

Secondary Outcomes (1)

• For each vaccine group the antibody responses to the H5 vaccine strain evaluated by hemaglutination inhibition (HI) assay

  Days 0 and 63 (21 days after the H5N1 immunization)

Other Outcomes (4)

• Exploratory: For each vaccine group the antibody responses to the non-H5 vaccine strains evaluated by hemaglutination inhibition (HI) assay

  Days 0 and 63 (21 days after the H5N1 immunization)

• Exploratory: For each vaccine group the influenza-specific cellular immune responses evaluated by quantitative reserve transcription polymerase chain reaction (qRT-PCR) assay

  Days 0, 42 and 63

• Exploratory: For each vaccine group the antibody responses to the H5 vaccine strain evaluated by single radial hemolysis (SRH) assay

  Days 0 and 63 (21 days after the H5N1 immunization)

Study Arms (3)

A: M-001 0.5mg & H5N1 influenza vaccine

EXPERIMENTAL

Biological/Vaccine: Two Multimeric-001 administrations followed by H5N1 influenza vaccine Two administrations of non adjuvanted M-001, 0.5mg followed by 3mcg Alum/H5N1 influenza vaccine at intervals of 19-23 days

Biological: Multimeric 001 (M-001); Biological: H5N1 influenza vaccine

B: M-001 1.0mg & H5N1 influenza vaccine

EXPERIMENTAL

Biological/Vaccine: Two Multimeric-001 administrations followed by H5N1 influenza vaccine Two administrations of non adjuvanted M-001, 1.0mg followed by 3mcg Alum/H5N1 influenza vaccine at intervals of 19-23 days

Biological: Multimeric 001 (M-001); Biological: H5N1 influenza vaccine

C: Saline & H5N1 influenza vaccine

PLACEBO COMPARATOR

Biological/Vaccine: Two saline administrations followed by H5N1 influenza vaccine Two administrations of saline followed by 3mcg Alum/H5N1 influenza vaccinated intervals of 19-23 days

Biological: H5N1 influenza vaccine; Biological: Saline

Interventions

Multimeric 001 (M-001) BIOLOGICAL

Multimeric 001 is a recombinant protein comprising 9 conserved peptides from influenza A and B

A: M-001 0.5mg & H5N1 influenza vaccine; B: M-001 1.0mg & H5N1 influenza vaccine

H5N1 influenza vaccine BIOLOGICAL

Alum adjuvanted whole virion inactivated H5N1 vaccine produced by FluArt (Hungary)

A: M-001 0.5mg & H5N1 influenza vaccine; B: M-001 1.0mg & H5N1 influenza vaccine; C: Saline & H5N1 influenza vaccine

Saline BIOLOGICAL

0.9% NaCl in double distilled water

C: Saline & H5N1 influenza vaccine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 60 years, inclusive;
• 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 (a combination of barrier plus 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);
• Is in good health, as determined by vital signs (heart rate, blood pressure, armpit temperature), blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), medical history, general physical examination, self-reported illness and clinical judgment of the investigator;
• Able to understand and comply with planned study procedures;
• Provides signed informed consent form after receiving a detailed explanation of the study protocol prior to any study procedures.

You may not qualify if:

• A potential subject who meets any if the following criteria will be excluded from participation in this study:
• Has a known allergy to components of the vaccine (e.g. egg products).
• Has a history of severe reactions following immunization.
• Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
• Has a positive urine pregnancy test prior to vaccination or women who are breastfeeding.
• Has a history of any of the following (reported by subjects):
• Acute disseminated encephalomyelitis (ADEM);
• Active neoplastic disease;
• Asthma or severe allergic disease;
• Bleeding disorders
• Chronic Hepatitis B and/or C infection;
• Chronic liver disease;
• Diabetes mellitus;
• Guillain-Barré syndrome;
• HIV;

Sponsors & Collaborators

• BiondVax Pharmaceuticals ltd.: lead
• Seventh Framework Programme: collaborator

Study Sites (1)

St Istvan St laszlo Hospital

Budapest, Hungary

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

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

• Dora Mathiasz, MD

  St Istvan St Laszlo hospital

  STUDY DIRECTOR

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: February 11, 2016
• First Posted: February 25, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: February 9, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)