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InfluenzaPhase 2NCT01419925

A Study to Assess the Safety and Immunogenicity of M-001 Influenza Vaccine as a Primer to TIV in Elderly Volunteers

A Phase 2 study testing Two Multimeric-001 administrations followed by TIV, One administration of Multimeric-001 followed by TIV and One administration of adjuvanted M-001 followed by TIV in people with Influenza and Healthy, run by BiondVax Pharmaceuticals ltd. at 1 site in Israel.

Completed

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

Official record
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Trial summary

"Multimeric-001" (M-001) has been recently developed, containing 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 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Healthy
What is being tested?
Two Multimeric-001 administrations followed by TIV, One administration of Multimeric-001 followed by TIV and One administration of adjuvanted M-001 followed by TIV
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteIsrael
Study dates
Aug 2011to Jan 2012
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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Males and females at the age of at least 65 years old
  • Eligible to receive the standard seasonal influenza vaccine according to the MOH guidelines.
  • Subjects who provide written informed consent to participate in the study.
  • Subjects able to adhere to the visit schedule and protocol requirements and are available to complete the study.
  • Haematology, chemistry and urinalysis values with no clinical significance or do not reflect a medical condition which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
  • Male subjects must agree to use a condom during the full term of the study period (including follow up) if female partner is not using an acceptable contraceptive method.
  • Subjects who are seronegative to at least one of the strains included in the seasonal vaccine against influenza for 2011- 2012

Who cannot join

  • Known history of significant medical disorder which, in the investigator's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
  • Subjects with known Guillain Barré Syndrome in the past.
  • Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within eight months prior to the screening visit.
  • Known hypersensitivity associated with previous influenza vaccination.
  • Use of an influenza antiviral medication within 4 weeks of vaccination.
  • Known hypersensitivity and/or allergy to any drug or vaccine.
Show all 14Show fewer
  • Known hypersensitivity to egg proteins (eggs or egg products), chicken proteins, or any of the components of the commercial vaccine (e.g., formaldehyde, and octoxinol 9 (Triton X-100) and neomycin).
  • Persons deficient in producing antibodies, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy.
  • History of any bleeding disorder or subjects with thrombocytopenia (since bleeding may occur following an intramuscular administration to these subjects).
  • Any clinically significant abnormality upon physical examination or in the clinical laboratory tests at screening visit which, according to the physician's judgment, might confound the results of the study or pose additional risk to the subject by participation in the study.
  • Positive serology for HIV, HCV antibody or HBsAg.
  • Any acute medical situation (e.g. acute infection, ongoing flu symptoms) with or without fever within 48 hours of vaccination, which is considered significant by the Investigator.
  • Subjects who participated in another interventional clinical study within 30 days prior to first dose
  • Subjects who are non-cooperative or unwilling to sign consent form.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Hadassah medical center

    Jerusalem

Other trials in Israel

About this study

Official title: A Phase II Multicenter, Randomized, Placebo Controlled Study to Assess the Safety and Immunogenicity of an IM Influenza Vaccine (Multimeric-001) Followed by Administration of TIV to Elderly Volunteers.

"Multimeric-001" (M-001) has been recently developed, containing 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 seasonal influenza vaccine in the elderly population. The current clinical study was designed to assess M-001's standalone and priming action in subjects over 65 years old.

This is a second Phase II study comprising 120 participants. Eligible subjects were randomized to receive to receive either two sequential non-adjuvanted or a single non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment), or one placebo (saline) injection, before receiving the TIV.

Read the detailed description

This was a two-center, randomized, placebo-controlled study. 120 subjects were randomized 1:1:1:1 into four groups to receive either two sequential non-adjuvanted or a single non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment), or one placebo (saline) injection, before receiving the TIV. Due to visual differences between placebo and treatment the study was partially blinded. Hemagglutinin inhibition (HAI) was evaluated at baseline and 3 weeks after standard trivalent inactivated influenza vaccine (TIV) vaccination as a measure of M-001's efficacy. Cell mediated immune (CMI) responses were also evaluated in some of the subjects who received non-adjuvanted and adjuvanted M-001 vaccinations. The subjects were monitored for safety throughout the study.

Conditions
Influenza, Healthy
Being tested
Two Multimeric-001 administrations followed by TIV, One administration of Multimeric-001 followed by TIV, One administration of adjuvanted M-001 followed by TIV, One administration of placebo followed by TIV
Keywords
influenza vaccine, peptide, universal, prime, boost, TIV, HAI, Hemagglutination Inhibition, elderly
Medical subject headings
Influenza, Human

What participants receive

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

  • Two Multimeric-001 administrations followed by TIVBiological

    Two administrations of non adjuvanted M-001, 500 mcg followed by TIV at intervals of 19-23 days

  • One administration of Multimeric-001 followed by TIVBiological

    One administration of non adjuvanted Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

  • One administration of adjuvanted M-001 followed by TIVBiological

    One administration of adjuvanted (Aluminum phosphate) Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days

  • One administration of placebo followed by TIVBiological

    One administration of saline (Placebo)followed by TIV at intervals of 19-23 days (serving as an active comparator)

Study groups in NCT01419925
Study groupRoleWhat they receive
Group AExperimentalTwo Multimeric-001 administrations followed by TIV
Receives: Biological: Two Multimeric-001 administrations followed by TIV
Group BExperimentalOne administration of Multimeric-001 followed by TIV
Receives: Biological: One administration of Multimeric-001 followed by TIV
Group CExperimentalOne administration of adjuvanted M-001 followed by TIV
Receives: Biological: One administration of adjuvanted M-001 followed by TIV
Group DActive comparatorOne administration of placebo followed by TIV
Receives: Biological: One administration of placebo followed by TIV

What is being measured

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

  1. Number of participants with adverse events

    Number of Participants with Adverse Events as a Measure of Safety and Tolerability were similar (not statistically significant) in the experimental and control group

    Number of Participants with Adverse Events possible/probably related to the study drug in each treatment group:

    Group A: Twice M-001 - 9 AEs Group B: Once M-001 - 5 AEs Group C: Once Alum-M-001 - 13 AEs Group D: Placebo - 7 AEs

    Measured: 63 days

Secondary outcomes (2)

  1. Immunity induced by priming and boosting, measured by HAI

    Hemagglutination Inhibition (HAI) test for anti influenza antibodies to TIV strains revealed an elevated proportion of participants achieving seroconversion in the groups primed with M-001 and boosted with TIV, as compared to participants given TIV alone. The viruses contained in the TIV were A/California/7/09, A/Perth/16/09 or B/Brisbane/60/08 . Enhanced Seroconversion and GMT post immunization were found in the experimental group primed with either adjuvanted or non adjuvanted M-001. Note that the superior HAI responses were demonstrated for both seasonal (H3N2 and B strain) and pandemic strains (swine H1N1 strain that is contained in the TIV).

    Measured: 21 days after boost immunization with TIV

  2. Cellular immunity

    Intracellular staining followed by FACS analysis of CD4/CD8 lymphocytes secreting IFN gamma showed elevated proportions of CD4+ cells secreting IFN gamma following exposure of PBMC from subjects immunized with M-001 to influenza antigens and to M-001. Note that the test was performed before boosting with TIV and hence demonstrates the cross immunity offered by immunization with M-001 alone and suggests a CD4+ mediated mechanism of action for M-001 as a universal primer.

    Measured: 21 days after M-001 immunization

Timeline

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

  1. First posted18 Aug 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionJan 2012
  4. Study completionJan 2012

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
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01419925
Sponsor's protocol ID
BVX-005
Status last verified
May 2014
First submitted
17 Aug 2011
Last updated
13 May 2014
Results posted
No
Data monitoring committee
No

Publications

  • Atsmon J, Caraco Y, Ziv-Sefer S, Shaikevich D, Abramov E, Volokhov I, Bruzil S, Haima KY, Gottlieb T, Ben-Yedidia T. Priming by a novel universal influenza vaccine (Multimeric-001)-a gateway for improving immune response in the elderly population. Vaccine. 2014 Oct 7;32(44):5816-23. doi: 10.1016/j.vaccine.2014.08.031. Epub 2014 Aug 28.

    PubMed 25173483

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Two Multimeric-001 administrations followed by TIV, One administration of Multimeric-001 followed by TIV and One administration of adjuvanted M-001 followed by TIV in people with Influenza and Healthy, run by BiondVax Pharmaceuticals ltd. at 1 site in Israel.

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 7 inclusion and 14 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 13 May 2014. 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 Israel. 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. 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?

Number of participants with adverse events (time frame: 63 days). 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 NCT01419925, which also lists 1 linked publication.

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 13 May 2014.

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