InfluenzaPhase 2NCT01146119
Further Investigation of an Intramuscular Influenza Vaccine (Multimeric-001)
A Phase 2 study testing Multimeric-001, 500 mcg, Adjuvanted PBS and PBS and TIV 15% in people with Influenza, run by BiondVax Pharmaceuticals ltd. at 2 sites in Israel.
Trial summary
This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Multimeric-001, 500 mcg, Adjuvanted PBS and PBS and TIV 15%
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2010to Jun 2011
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between the age of 18 and 49 years (inclusive).
- Subjects who provide written informed consent to participate in the study.
- Subjects able to adhere to the visit schedule and protocol requirements and be 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.
- Female of childbearing age must agree to use an acceptable method of contraception and male subjects should use a condom throughout the study period (until termination visit) if female partner is not using an effective contraceptive method.
- Subjects who are seronegative to at least one of the strains included in the seasonal vaccine against influenza for 2011.
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.
- Two or more hospitalizations within the last year prior to screening visit.
- Known bleeding disorders including hemophilia or thrombocytopenia, or treatment with anticoagulant therapy (risk of bleeding with intramuscular injection).
- Immunocompromised patients and those receiving concomitant immunosuppressive therapy; or other immune modulating drugs including chronic steroid treatment.
- Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within eight months prior to the screening visit.
Show all 20Show fewer
- Administration of any vaccine 30 days before the screening visit.
- Known hypersensitivity to previous influenza vaccination.
- Use of an influenza antiviral medication within 4 weeks of vaccination.
- Known hypersensitivity and/or allergy to any drug or vaccine.
- Known hypersensitivity to egg proteins (eggs or egg products), chicken proteins, or any of the vaccine components.
- Known history of drug or alcohol abuse.
- 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.
- Increased liver enzymes more than 2.5 times above the upper reference level.
- 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 of significance by the Principal Investigator.
- Pregnant or lactating women at entry to study and those who are unwilling to agree to continue to use acceptable methods of contraception for two months after completion of the study (if applicable).
- Positive blood pregnancy test on screening.
- Subjects who participated in any clinical study within 30 days prior to study entry
- Subjects who are non-cooperative or unwilling to sign consent form.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Clinical Research Center, Hadassah Medical Center
Jerusalem
Clinical Research Center, Tel-Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: A Phase II, Randomized, Two Stage, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
This is a multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.
Read the detailed description
This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled study comprising 200 participants. Eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg - 64 subjects.
Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS (Placebo)twice - 32 subjects. Participants from administrations A and B will be further immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.
Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose - 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with 50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once with 50% of TIV dose - 24 subjects
- Conditions
- Influenza
- Being tested
- Multimeric-001, 500 mcg, Adjuvanted PBS, PBS and TIV 15%, PBS and TIV 50%
- Keywords
- HAI, Influenza, prime, boost, immune response, seroconversion, universal, vaccine
- Medical subject headings
- Influenza, Human, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimeric-001, 500 mcgBiological
Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days.
Adjuvanted PBSBiological
Also called placebo
Adjuvanted PBS was administered twice with an interval of 19-23 days.
PBS and TIV 15%Biological
PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered.
PBS and TIV 50%Biological
PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered.
| Study group | Role | What they receive |
|---|---|---|
| Multimeric-001, Adjuvanted | Experimental | 64 subjects received 2 injections of Adjuvanted Multimeric-001, 500 mcg with an interval of 21 days and then 60 days later were further immunized with a 15% dose of commercial seasonal trivalent vaccine (season 2011). Receives: Biological: Multimeric-001, 500 mcg |
| PBS and TIV 15% | Active comparator | 32 subjects received 2 injections of PBS (Phosphate Buffered Saline) with an interval of 21 days and then were further immunized 60 days later with a 15% dose of commercial seasonal trivalent vaccine (season 2011). Receives: Biological: PBS and TIV 15% |
| Placebo, Adjuvanted | Placebo comparator | 32 subjects received Adjuvanted PBS (Placebo) with an interval of 21 days. Receives: Biological: Adjuvanted PBS |
| Co-administration M-001 and TIV 15% | Experimental | 24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 15%. Receives: Biological: Multimeric-001, 500 mcg |
| Co administration of M-001 and TIV 50% | Experimental | 24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 50%. Receives: Biological: Multimeric-001, 500 mcg |
| Co administration of PBS and TIV 50% | Active comparator | 24 subjects received 2 injections on the same day, one injection containing PBS and the other containing TIV 50%. Receives: Biological: PBS and TIV 50% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of Participants with Adverse Events possible/probably related to the study drug in each group were similar in the experimental and control groups.
Measured: From day 0 until day 221
Anti Multimeric-001 antibodies
Direct Elisa assay to test the titer of human antibodies that recognize the Multimeric-001 protein. Humoral immunity was manifested 21 and 60 days post immunization by significantly elevated anti-M-001 IgG levels among subjects administered twice with adjuvanted M-001
Measured: 21 days after second immunization with M-001
Secondary outcomes (1)
Hemagglutination Inhibition (HAI) test for anti influenza antibodies
The serum is tested for its ability to adhere to influenza virus and thus inhibit the Hemagglutination reaction. Adjuvanted M-001 co-administered with partial dose of TIV (Vaxigrip, 50%) was effective in enhancing immunity to influenza-related antigens, as manifested by increased HAI antibody responses toward viruses contained in the TIV as well as toward non-TIV virus strains.
Measured: 21 days post co administration of M-001 and TIV 50%
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2011
- Study completionJun 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- BiondVax Pharmaceuticals ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Atsmon, MD, Principal investigator, Clinical Research Center, Tel-Aviv Sourasky Medical CenterYosef Caraco, Phd, Principal investigator, Clinical Research Center, Hadassah Medical Center, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146119
- Sponsor's protocol ID
- BVX-004
- Status last verified
- Jul 2012
- First submitted
- 13 Jun 2010
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Two Stage, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of an Intramuscular Influenza Vaccine (Multimeric-001) Injected to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01146119
- Acronym / sponsor ID
- BVX-004
- Conditions
- Influenza
- Keywords
- HAI, Influenza, prime, boost, immune response, seroconversion, universal, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BiondVax Pharmaceuticals ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jun 2010 (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 multi-center, randomized, two stage, double-blind, placebo-controlled administration study comprising 200 healthy participants.
Detailed description
This is a Phase II multi-center, randomized, two stage, double-blind, placebo-controlled study comprising 200 participants. Eligible subjects will be randomized to receive one of the following administrations (as two single IM injections with an interval of 21 days between each injection Administration A: Prime twice with Adjuvanted Multimeric-001 500 mcg - 64 subjects.
Administration B: PBS (Placebo) twice - 32 subjects. Administration C: Adjuvanted PBS (Placebo)twice - 32 subjects. Participants from administrations A and B will be further immunized with a 15% dose of commercial seasonal trivalent vaccine for 2011 on day 81.
Administration D: Adjuvanted Multimeric-001 500 mcg coadministered once with 15% of TIV dose - 24 subjects. Administration E: Adjuvanted Multimeric-001 500 mcg coadministered once with 50% of TIV dose - 24 subjects Administration group F: PBS (Placebo) co-administered once with 50% of TIV dose - 24 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Multimeric-001, Adjuvanted | Experimental | Biological: Multimeric-001, 500 mcg64 subjects received 2 injections of Adjuvanted Multimeric-001, 500 mcg with an interval of 21 days and then 60 days later were further immunized with a 15% dose of commercial seasonal trivalent vaccine (season 2011). |
| PBS and TIV 15% | Active comparator | Biological: PBS and TIV 15%32 subjects received 2 injections of PBS (Phosphate Buffered Saline) with an interval of 21 days and then were further immunized 60 days later with a 15% dose of commercial seasonal trivalent vaccine (season 2011). |
| Placebo, Adjuvanted | Placebo comparator | Biological: Adjuvanted PBS32 subjects received Adjuvanted PBS (Placebo) with an interval of 21 days. |
| Co-administration M-001 and TIV 15% | Experimental | Biological: Multimeric-001, 500 mcg24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 15%. |
| Co administration of M-001 and TIV 50% | Experimental | Biological: Multimeric-001, 500 mcg24 subjects received 2 injections on the same day, one injection containing Adjuvanted Multimeric-001 500 mcg and the other containing TIV 50%. |
| Co administration of PBS and TIV 50% | Active comparator | Biological: PBS and TIV 50%24 subjects received 2 injections on the same day, one injection containing PBS and the other containing TIV 50%. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males and females between the age of 18 and 49 years (inclusive).
- Subjects who provide written informed consent to participate in the study.
- Subjects able to adhere to the visit schedule and protocol requirements and be 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.
- Female of childbearing age must agree to use an acceptable method of contraception and male subjects should use a condom throughout the study period (until termination visit) if female partner is not using an effective contraceptive method.
Key exclusion criteria (20 listed)
- 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.
- Two or more hospitalizations within the last year prior to screening visit.
- Known bleeding disorders including hemophilia or thrombocytopenia, or treatment with anticoagulant therapy (risk of bleeding with intramuscular injection).
- Immunocompromised patients and those receiving concomitant immunosuppressive therapy; or other immune modulating drugs including chronic steroid treatment.
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 |
|---|---|---|
| Multimeric-001, 500 mcgAdjuvanted Multimeric-001 was administered twice with an interval of 19-23 days. | Biological | Co administration of M-001 and TIV 50%, Co-administration M-001 and TIV 15%, Multimeric-001, Adjuvanted |
| Adjuvanted PBSAlso: placeboAdjuvanted PBS was administered twice with an interval of 19-23 days. | Biological | Placebo, Adjuvanted |
| PBS and TIV 15%PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered. | Biological | PBS and TIV 15% |
| PBS and TIV 50%PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered. | Biological | Co administration of PBS and TIV 50% |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: From day 0 until day 221
Number of Participants with Adverse Events possible/probably related to the study drug in each group were similar in the experimental and control groups.
Anti Multimeric-001 antibodies
Time frame: 21 days after second immunization with M-001
Direct Elisa assay to test the titer of human antibodies that recognize the Multimeric-001 protein. Humoral immunity was manifested 21 and 60 days post immunization by significantly elevated anti-M-001 IgG levels among subjects administered twice with adjuvanted M-001
1 secondary outcome
Hemagglutination Inhibition (HAI) test for anti influenza antibodies
Time frame: 21 days post co administration of M-001 and TIV 50%
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 31 Jul 2012.
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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
Clinical Research Center, Tel-Aviv Sourasky Medical Center
Yosef Caraco, Phd principal investigator
Clinical Research Center, Hadassah Medical Center, Jerusalem
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Multimeric-001, 500 mcg, Adjuvanted PBS and PBS and TIV 15% in people with Influenza, run by BiondVax Pharmaceuticals ltd. at 2 sites 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 6 inclusion and 20 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 as a Measure of Safety and Tolerability (time frame: From day 0 until day 221). 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?
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 31 Jul 2012.