AzTrials
AzTrials

InfluenzaPhase 2NCT02691130

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

A Phase 2 study testing Multimeric 001 (M-001), H5N1 influenza vaccine and Saline in people with Influenza and Healthy, run by BiondVax Pharmaceuticals ltd. at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Healthy
What is being tested?
Multimeric 001 (M-001), H5N1 influenza vaccine and Saline
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
224 participants
Where
1 siteHungary
Study dates
Nov 2015to Jan 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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):
Show all 31Show fewer
  • 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;
  • Rheumatoid arthritis or other autoimmune diseases;
  • Severe renal disease;
  • Transplant recipients;
  • Unstable or progressive neurological disorders.
  • Receipt of medicines/treatments that may affect evaluation of immunogenicity such as:
  • Oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs;
  • Immunoglobulin or other blood products (within the 3 months prior to vaccination in this study);
  • Experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent (during the study period).
  • Influenza antiviral medication (within the 4 weeks prior to vaccination in this study).
  • Has received any influenza vaccine within 6 months prior to vaccination in this study.
  • Has influenza-like illness within 6 months prior to vaccination in this study.
  • Has an acute illness, including an armpit temperature greater than 38 degrees Celsius (oC), within 1 week of vaccination.
  • Has a history of alcohol or drug abuse.
  • Any abnormal haematology values and/or serum chemistries judged by the Investigator as clinically significant.
  • Ineligible subject based on the judgement of the investigator.
  • In case there is uncertainty about the participant's medical status regarding any of the exclusion criteria mentioned, the participant's primary care physician will be consulted. Consultation of the primary care physician will only take place after having received written approval from the participant, and will concern medical information about exclusion criteria only.

Trial locations and contacts

1 site in 1 country.

Hungary1 site

  • St Istvan St laszlo Hospital

    Budapest

Other trials in Hungary

About this study

Official title: A Multicenter, Randomized, Double-blind, Active-controlled Phase 2b Trial [Part of EU-funded UNISEC Project] to Assess the Immunogenicity & Safety of a BiondVax's Influenza Vaccine (M-001) Followed by H5N1 Vaccine in Healthy Adults

"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.

Read the detailed description

This is a multi-center, randomized, double blind active-controlled Phase 2b study. 222 subjects will be randomized 1:1:1 into three groups to receive two sequential non-adjuvanted 0.5 mg or 1.0mg intramuscular injection of M-001 (treatment), or two placebo (saline) injection, before receiving the Alum adjuvanted H5N1 vaccine at a sub optimal dose of 3mcg. Hemagglutinin inhibition (HAI) will be evaluated at baseline and 3 weeks after H5N1 whole virion inactivated pandemic influenza vaccination as a measure of M-001's ability to enhance the humoral response. Cell mediated immune (CMI) responses will also be evaluated at baseline and after immunization with M-001 as a measure of M-001's standalone immunogenicity. The subjects will monitored for safety throughout the study until day 180.

Conditions
Influenza, Healthy
Being tested
Multimeric 001 (M-001), H5N1 influenza vaccine, Saline
Keywords
influenza, vaccine, universal, peptide, prime, boost, HAI, CMI, UNISEC
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimeric 001 (M-001)Biological

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

  • H5N1 influenza vaccineBiological

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

  • SalineBiological

    0.9% NaCl in double distilled water

Study groups in NCT02691130
Study groupRoleWhat they receive
A: M-001 0.5mg & H5N1 influenza vaccineExperimentalBiological/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
Receives: Biological: Multimeric 001 (M-001); Biological: H5N1 influenza vaccine
B: M-001 1.0mg & H5N1 influenza vaccineExperimentalBiological/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
Receives: Biological: Multimeric 001 (M-001); Biological: H5N1 influenza vaccine
C: Saline & H5N1 influenza vaccinePlacebo comparatorBiological/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
Receives: Biological: H5N1 influenza vaccine; Biological: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    All subjects

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

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

    All subjects

    Measured: Day 0 to Day 180 (study conclusion)

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

    All subjects

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

Secondary outcomes (1)

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

    All subjects

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionOct 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691130
Sponsor's protocol ID
BVX-007
Status last verified
Feb 2018
First submitted
11 Feb 2016
Last updated
9 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No: summary of data per group will be shared, not IPD.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Multimeric 001 (M-001), H5N1 influenza vaccine and Saline in people with Influenza and Healthy, run by BiondVax Pharmaceuticals ltd. at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For each vaccine group the incidence rate of subjects with solicited AE(s) with 95% confidence interval (time frame: Day 0 to Day 42 (21 days after the last M-001 dosing)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02691130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in