HealthyPhase 1/2NCT00877448

A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001)

A Phase 1/2 study testing Adjuvanted Multimeric-001 250 Mcg, Multimeric-001 250 Mcg and Phosphate Buffered saline in people with 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

A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Adjuvanted Multimeric-001 250 Mcg, Multimeric-001 250 Mcg and Phosphate Buffered saline
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteIsrael
Study dates: Jun 2009to Nov 2009
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and females between 18 and 55 years (inclusive) of age.
Non-smoking (by declaration) for a period of at least 6 months.
Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Haematology and Chemistry values within normal ranges or with no clinical significance
Subjects who provide written informed consent to participate in the study

Who cannot join

Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
Ongoing flu symptoms or influenza
Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit.
Treatment with immune immunosuppressant drugs or other immune enhancing drugs.
Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit.
Administration of any vaccine 30 days before the screening visit.

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Known history of drug or alcohol abuse.
Known history of HIV, hepatitis C or B virus (HCV or HBV)
Subjects with known Guillain Barré Syndrome in the past
2 or more hospitalization within the last year prior to screening visit
Increased liver enzymes 2.5 times above the upper reference level
Known hypersensitivity and/or allergy to any drugs
Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
Subjects who participated in another clinical study within 30 days prior to study entry
Subjects who are non-cooperative or unwilling to sign consent form.
Pregnant or lactating women at entry to study and those that are unwilling to agree to continue precautions for two months after completion of the study

Trial locations and contacts

1 site in 1 country.

Israel1 site

Tasmc Crc
Tel Aviv

Other trials in Israel

About this study

Official title: A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose Safety Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers

A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.

Conditions: Healthy
Being tested: Adjuvanted Multimeric-001 250 Mcg, Multimeric-001 250 Mcg, Phosphate Buffered saline, Adjuvanted PBS, Adjuvanted Multimeric-001 500 Mcg
Keywords: INFLUENZA, VACCINE, UNIVERSAL, SAFETY
Medical subject headings: Influenza, Human

What participants receive

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

Adjuvanted Multimeric-001 250 McgBiological
Multimeric-001 250 McgBiological
Phosphate Buffered salineBiological
Adjuvanted PBSBiological
Adjuvanted Multimeric-001 500 McgBiological
Multimeric-001 500 McgBiological
Multimeric-001 125 McgBiological

Study groups in NCT00877448
Study group	Role	What they receive
Multimeric-001 250 Mcg	Experimental	Multimeric-001 250 Mcg in PBS Receives: Biological: Adjuvanted Multimeric-001 250 Mcg
Adjuvanted Multimeric-001 250 Mcg	Experimental	250 Mcg in montanide Receives: Biological: Multimeric-001 250 Mcg
Phosphate Buffered saline	Placebo comparator	Non-adjuvanted placebo Receives: Biological: Phosphate Buffered saline
Adjuvanted PBS	Placebo comparator	Adjuvant was montanide Receives: Biological: Adjuvanted PBS
Multimeric-001 500 Mcg	Experimental	Multimeric-001 in PBS Receives: Biological: Multimeric-001 500 Mcg
Adjuvanted Multimeric-001 500 Mcg	Experimental	Adjuvant was montanide Receives: Biological: Adjuvanted Multimeric-001 500 Mcg
Multimeric-001 125 Mcg	Experimental	Multimeric-001 in PBS Receives: Biological: Multimeric-001 125 Mcg

What is being measured

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

Adverse Events
Number of adverse events per cohort
Measured: day 0 until day 42 (termination visit)
Treatment-related Adverse Events
Number of treatment-related adverse events per cohort
Measured: Day 0 until day 42 (termination visit)

Timeline

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

Jun 2009Nov 2009

First posted7 Apr 2009 (estimated)
Study startJun 2009
Primary completionOct 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00877448
Sponsor's protocol ID: BVX002
Status last verified: Feb 2023
First submitted: 28 Jan 2009
Last updated: 7 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Atsmon J, Kate-Ilovitz E, Shaikevich D, Singer Y, Volokhov I, Haim KY, Ben-Yedidia T. Safety and immunogenicity of multimeric-001--a novel universal influenza vaccine. J Clin Immunol. 2012 Jun;32(3):595-603. doi: 10.1007/s10875-011-9632-5. Epub 2012 Feb 9.
PubMed 22318394

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Randomized, Single-Blind, Placebo-Controlled Escalating Double-Dose Safety Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
ClinicalTrials.gov ID: NCT00877448
Acronym / sponsor ID: BVX002
Conditions: Healthy
Keywords: INFLUENZA, VACCINE, UNIVERSAL, SAFETY
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: BiondVax Pharmaceuticals ltd.Industry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Oct 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 7 Apr 2009 (estimated)
Results: Posted 27 Mar 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A phase I/II, randomized, single-blind, placebo-controlled escalating double-dose safety study of an intramuscular universal influenza vaccine (Multimeric-001) injected to healthy volunteers.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 7

Arm	Type	Receives
Multimeric-001 250 Mcg	Experimental	Biological: Adjuvanted Multimeric-001 250 McgMultimeric-001 250 Mcg in PBS
Adjuvanted Multimeric-001 250 Mcg	Experimental	Biological: Multimeric-001 250 Mcg250 Mcg in montanide
Phosphate Buffered saline	Placebo comparator	Biological: Phosphate Buffered salineNon-adjuvanted placebo
Adjuvanted PBS	Placebo comparator	Biological: Adjuvanted PBSAdjuvant was montanide
Multimeric-001 500 Mcg	Experimental	Biological: Multimeric-001 500 McgMultimeric-001 in PBS
Adjuvanted Multimeric-001 500 Mcg	Experimental	Biological: Adjuvanted Multimeric-001 500 McgAdjuvant was montanide
Multimeric-001 125 Mcg	Experimental	Biological: Multimeric-001 125 McgMultimeric-001 in PBS

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy males and females between 18 and 55 years (inclusive) of age.
Non-smoking (by declaration) for a period of at least 6 months.
Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Haematology and Chemistry values within normal ranges or with no clinical significance
Subjects who provide written informed consent to participate in the study

Key exclusion criteria (16 listed)

Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
Ongoing flu symptoms or influenza
Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit.
Treatment with immune immunosuppressant drugs or other immune enhancing drugs.
Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adjuvanted Multimeric-001 250 Mcg	Biological	Multimeric-001 250 Mcg
Multimeric-001 250 Mcg	Biological	Adjuvanted Multimeric-001 250 Mcg
Phosphate Buffered saline	Biological	Phosphate Buffered saline
Adjuvanted PBS	Biological	Adjuvanted PBS
Adjuvanted Multimeric-001 500 Mcg	Biological	Adjuvanted Multimeric-001 500 Mcg
Multimeric-001 500 Mcg	Biological	Multimeric-001 500 Mcg
Multimeric-001 125 Mcg	Biological	Multimeric-001 125 Mcg

Primary outcome

Adverse Events
Time frame: day 0 until day 42 (termination visit)
Number of adverse events per cohort
Treatment-related Adverse Events
Time frame: Day 0 until day 42 (termination visit)
Number of treatment-related adverse events per cohort

Results and safety

Results posted to the registry on 27 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multimeric-001 250 mcg in PBS	10	10
Adjuvanted Multimeric -001 250 mcg	10	9
PBS (Placebo)	10	10
Adjuvanted PBS	10	9
Multimeric-001 in PBS 500 mcg	10	10
Adjuvanted Multimeric-001 500 mcg	10	9
Multimeric-001 125 mcg	3	3

Primary outcome: Adverse Events

Time frame: day 0 until day 42 (termination visit). Number. Unit: number of reported events

Measure	Multimeric-001 250 mcg in PBS n = 10	Adjuvanted Multimeric -001 250 mcg n = 10	PBS (Placebo) n = 10	Adjuvanted PBS n = 10	Multimeric-001 in PBS 500 mcg n = 10	Adjuvanted Multimeric-001 500 mcg n = 10	Multimeric-001 125 mcg n = 3
Value	46	28	29	36	42	20	2

Primary outcome: Treatment-related Adverse Events

Time frame: Day 0 until day 42 (termination visit). Number. Unit: number of reported events

Measure	Multimeric-001 250 mcg in PBS n = 10	Adjuvanted Multimeric -001 250 mcg n = 10	PBS (Placebo) n = 10	Adjuvanted PBS n = 10	Multimeric-001 in PBS 500 mcg n = 10	Adjuvanted Multimeric-001 500 mcg n = 10	Multimeric-001 125 mcg n = 3
Value	8	11	3	17	3	9	0

Adverse events

Time frame: day 0 until day 42 (termination visit). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multimeric-001 250 mcg in PBS	0 of 10 (0%)	10 of 10 (100%)	Not reported
Adjuvanted Multimeric -001 250 mcg	0 of 10 (0%)	8 of 10 (80%)	Not reported
PBS (Placebo)	0 of 10 (0%)	7 of 10 (70%)	Not reported
Adjuvanted PBS	0 of 10 (0%)	8 of 10 (80%)	Not reported
Multimeric-001 in PBS 500 mcg	0 of 10 (0%)	10 of 10 (100%)	Not reported
Adjuvanted Multimeric-001 500 mcg	0 of 10 (0%)	8 of 10 (80%)	Not reported
Multimeric-001 125 mcg	0 of 3 (0%)	1 of 3 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22318394Atsmon J, Kate-Ilovitz E, Shaikevich D, Singer Y, Volokhov I, Haim KY, Ben-Yedidia T. Safety and immunogenicity of multimeric-001--a novel universal influenza vaccine. J Clin Immunol. 2012 Jun;32(3):595-603. doi: 10.1007/s10875-011-9632-5. Epub 2012 Feb 9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacob Atsmon, MD principal investigator

Sourasky Medical Center, Tel Aviv, Israel

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adjuvanted Multimeric-001 250 Mcg, Multimeric-001 250 Mcg and Phosphate Buffered saline in people with 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 5 inclusion and 16 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 7 Mar 2023. 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. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Yes. Results are posted in the registry (first posted 27 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Adverse Events (time frame: day 0 until day 42 (termination visit)). The study lists 2 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 NCT00877448, 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 7 Mar 2023.