InfluenzaPhase 2BVX006NCT02293317
Phase II Study to Assess Safety & Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by TIV
A Phase 2 study testing M-001, TIV and Saline in people with Influenza, run by BiondVax Pharmaceuticals ltd. at 1 site in Israel.
Trial summary
This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age. All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- M-001, TIV and Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Jun 2015
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females between ≥50 - ≤65 years old at the time expected for the first injection.
- Eligible to receive the standard seasonal influenza vaccine according to the ministry of health 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.
- Pre-menopausal female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
- Postmenopausal women, defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form.
- Subjects must agree to use an acceptable contraceptive method the full term of the study period (including follow up).
Who cannot join
- Subjects who are likely, in the opinion of the investigator, to confound the results of the study or may be exposed to additional risks by participation in the study, based on medical history, vital signs, ECG, physical examination and safety lab tests.
- Subjects with known Guillain Barré Syndrome in the past.
- Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus (based on the assessment of the investigator) within eight months prior to first vaccination.
- Known hypersensitivity associated with previous influenza vaccination.
- Use of an influenza antiviral medication within 4 weeks of first vaccination.
- Known allergy to egg protein
Show all 14Show fewer
- Known hypersensitivity and/or allergy to any drug or vaccine.
- 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).
- Positive serology for Human immunodeficiency virus (HIV) , Hepatitis C Virus (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.
- Pregnant or currently lactating women.
- 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
Clinical Research Center, Tel-Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by a Seasonal Trivalent Influenza Vaccine (TIV)
This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age.
All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.
Read the detailed description
Subjects will undergo screening procedures within 30 days prior to first vaccination which will include medical history, vital signs, ECG, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and circulating Interferon gamma (IFN-g). They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (± 15 min) at which time they will be released from the Clinical research center.
The second treatment will take place 21 (±2) days after the first vaccination. Procedures will be the same as that of Visit 2 Additional two follow-up visits will take place at approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the second vaccination. Procedures will be the same as that of Visit 2 21 days later, each subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.
A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.
- Conditions
- Influenza
- Being tested
- M-001, TIV, Saline
- Keywords
- Influenza Prime universal vaccine M-001 Multimeric
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-001Biological
Also called Multimeric-001
A recombinant epitope based universal vaccine against seasonal and pandemic influenza
TIVDrug
HA based seasonal influenza vaccine, for 2014/15 seson
SalineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| M-001 0.5mg & TIV | Experimental | M-001 (0.5mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) Receives: Biological: M-001; Drug: TIV |
| M-001 1.0mg & TIV | Experimental | M-001 (1.0mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) Receives: Biological: M-001; Drug: TIV |
| Placebo & TIV | Placebo comparator | 0.3ml Saline administered Intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) Receives: Drug: TIV; Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events in treatment vs control group
Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be measured in the experimental and control group, both local and systemic adverse events will be followed.
Measured: 3 months (from first visit to termination visit for each subject)
Secondary outcomes (2)
Immunity induced by priming and boosting, measured by HAI (Hemagglutination Inhibition)
To characterize humoral immunity, Hemagglutination Inhibition (HAI) test for anti influenza antibodies to TIV strains will be measured after boosting with TIV, proportion of participants achieving seroconversion in the groups primed with M-001 and boosted with TIV, will be compared to participants given TIV alone.
Measured: Day 84 (21 days after TIV injection)
Number of participants with cell mediated immune response in treatment vs control group
To characterize the cell mediated immune response, Fluorescence activated cell sorter (FACS) analysis for CD4/CD8 lymphocytes will be performed after 3 immunizations with M-001 as compared to the control group (injected 3 times with saline)
Measured: Day 63 (21 days after immunization with M-001)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiondVax Pharmaceuticals ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tamar Ben Yedidia, PhD, Study chair, BiondVax Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293317
- Sponsor's protocol ID
- BVX-006
- Acronym
- BVX006
- Status last verified
- Nov 2014
- First submitted
- 9 Nov 2014
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety and Immunogenicity of Multimeric-001 Influenza Vaccine, Followed by a Seasonal Trivalent Influenza Vaccine (TIV)
- ClinicalTrials.gov ID
- NCT02293317
- Acronym / sponsor ID
- BVX006 / BVX-006
- Conditions
- Influenza
- Keywords
- Influenza Prime universal vaccine M-001 Multimeric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BiondVax Pharmaceuticals ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-site, randomized, double-blind, placebo-controlled study of Multimeric-001 in thirty six (36) volunteers 50-65 years of age.
All subjects will receive an intramuscular (IM) injection, in each one of three visits, with a 21±2 days interval between treatments.
Detailed description
Subjects will undergo screening procedures within 30 days prior to first vaccination which will include medical history, vital signs, ECG, physical examination and safety blood and urine lab tests.
On the first treatment visit, eligible subjects will undergo pre-dose physical examination and vital signs, and a blood sample will be drawn for baseline cellular immunogenicity and circulating Interferon gamma (IFN-g). They will then receive an IM injection of either vaccine or placebo, according to the above treatment assignment, into the deltoid muscle preferably of the same arm. The subjects will remain under medical supervision for 2 hrs (± 15 min) at which time they will be released from the Clinical research center.
The second treatment will take place 21 (±2) days after the first vaccination. Procedures will be the same as that of Visit 2 Additional two follow-up visits will take place at approximately 24 hrs and 48h The third treatment will take place 21 (±2) days after the second vaccination. Procedures will be the same as that of Visit 2 21 days later, each subject will be immunized with the seasonal influenza vaccine approved for 2014/15 year.
A Study Termination visit will take place at 21 (±2) days after last vaccination. Adverse events (AEs) and changes in concomitant medications will be recorded, vital signs will be measured and the subjects will undergo physical examination and ECG. Blood and urine samples will be collected for safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| M-001 0.5mg & TIV | Experimental | Biological: M-001, Drug: TIVM-001 (0.5mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) |
| M-001 1.0mg & TIV | Experimental | Biological: M-001, Drug: TIVM-001 (1.0mg) administered intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) |
| Placebo & TIV | Placebo comparator | Drug: TIV, Other: Saline0.3ml Saline administered Intramuscular 3 times at 21 days intervals followed by vaccination with Trivalent Influenza Vaccine (TIV) |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females between ≥50 - ≤65 years old at the time expected for the first injection.
- Eligible to receive the standard seasonal influenza vaccine according to the ministry of health 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.
- Pre-menopausal female subjects must have a negative serum pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or declare that they are abstaining from sexual intercourse, from the screening visit through the study termination visit or be surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Key exclusion criteria (14 listed)
- Subjects who are likely, in the opinion of the investigator, to confound the results of the study or may be exposed to additional risks by participation in the study, based on medical history, vital signs, ECG, physical examination and safety lab tests.
- Subjects with known Guillain Barré Syndrome in the past.
- Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus (based on the assessment of the investigator) within eight months prior to first vaccination.
- Known hypersensitivity associated with previous influenza vaccination.
- Use of an influenza antiviral medication within 4 weeks of first vaccination.
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 |
|---|---|---|
| M-001Also: Multimeric-001A recombinant epitope based universal vaccine against seasonal and pandemic influenza | Biological | M-001 0.5mg & TIV, M-001 1.0mg & TIV |
| TIVHA based seasonal influenza vaccine, for 2014/15 seson | Drug | M-001 0.5mg & TIV, M-001 1.0mg & TIV, Placebo & TIV |
| SalinePlacebo | Other | Placebo & TIV |
Primary outcome
Number of participants with adverse events in treatment vs control group
Time frame: 3 months (from first visit to termination visit for each subject)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability will be measured in the experimental and control group, both local and systemic adverse events will be followed.
2 secondary outcomes
Immunity induced by priming and boosting, measured by HAI (Hemagglutination Inhibition)
Time frame: Day 84 (21 days after TIV injection)
Number of participants with cell mediated immune response in treatment vs control group
Time frame: Day 63 (21 days after immunization with M-001)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Tamar Ben Yedidia, PhD study chair
BiondVax Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing M-001, TIV and Saline in people with Influenza, 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 23 Feb 2016. 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 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 in treatment vs control group (time frame: 3 months (from first visit to termination visit for each subject)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2016.