InfluenzaPhase 1FLU003NCT02335164
A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults
A Phase 1 study testing recombinant influenza hemagglutinin, Advax1 and Advax2 in people with Influenza, run by Vaxine Pty Ltd at 1 site in Australia.
Trial summary
Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- recombinant influenza hemagglutinin, Advax1 and Advax2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2015to 1 May 2019
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ambulatory males or females aged 18 years and over
- Able to provide written informed consent
- Willing and able to comply with the protocol for the duration of the study.
- Not planning to have seasonal influenza vaccine within 2 months from the time of the first trial immunization
Who cannot join
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- Receipt of another investigational agent within 28 days preceding initiation of treatment.
- Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled, Blinded Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian H5 Influenza Vaccine in Adults
Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection
Read the detailed description
This is a study to test new vaccine formulations against pandemic avian influenza ("bird flu"). Bird flu is a potentially deadly disease that is caused by influenza virus from birds. It is not the same as the common seasonal flu for which there is a seasonal vaccine released around March each year. To date, bird flu due to the H5N1 strain of influenza virus has infected over 500 people mainly in Asia resulting in death in more than half the cases. More recently there has been an outbreak of another bird flu virus in China known as H9N7 that is also highly lethal when it infects humans. Vaccination is the single most effective measure to prevent infection from bird flu viruses such as H5N1 or H9N7 should such a pandemic occur. In the event of a major bird flu pandemic outbreak, vaccine supplies are likely to be very limited, as there is not currently sufficient manufacturing capacity to provide enough vaccine quickly for the whole population. Research is needed on how to make the pandemic flu vaccine more effective but also how to stretch vaccine supplies using a strategy called 'antigen-sparing'. This can potentially be achieved by using an important ingredient called an 'adjuvant'. Adjuvants act by stimulating the immune system to make vaccines more effective. This study will test Advax adjuvants which are based on delta inulin in combination with recombinant hemagglutinin from the H5N1 influenza virus serotype.
- Conditions
- Influenza
- Being tested
- recombinant influenza hemagglutinin, Advax1, Advax2
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant influenza hemagglutininBiological
recombinant influenza hemagglutinin
Advax1Biological
Delta inulin adjuvant formulation 1
Advax2Biological
Delta inulin adjuvant formulation 2
| Study group | Role | What they receive |
|---|---|---|
| HA 45ug | Experimental | recombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin |
| HA 45ug+Advax1 | Experimental | recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax1 |
| HA 45ug+Advax2 | Experimental | recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax2 |
| HA 15ug+Advax1 | Experimental | recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax1 |
| HA 15ug+Advax2 | Experimental | recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax2 |
| HA 5ug+Advax1 | Experimental | recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax1 |
| HA 5ug+Advax2 | Experimental | recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax2 |
| HA 2.5ug+Advax2 | Experimental | recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin; Biological: Advax2 |
| HA 15ug | Experimental | recombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses Receives: Biological: recombinant influenza hemagglutinin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events
The frequency of adverse events will be compared between groups
Measured: 12 months
Secondary outcomes (1)
Hemagglutination inhibition assay
Seroconversion, seroprotection and GMT fold increase will be compared between groups at each time point using hemagglutination inhibition titers
Measured: 1 month post each immunization and 11 months post final immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJul 2015
- Primary completion1 Dec 2017
- Study completion1 May 2019
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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vaxine Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Flinders University, Australian Respiratory and Sleep Medicine Institute
- Responsible party
- Sponsor
- Investigators
- Dimitar Sajkov, FRACP, PhD, Principal investigator, Flinders University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335164
- Sponsor's protocol ID
- FLU003
- Acronym
- FLU003
- Status last verified
- May 2019
- First submitted
- 4 Jan 2015
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Blinded Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian H5 Influenza Vaccine in Adults
- ClinicalTrials.gov ID
- NCT02335164
- Acronym / sponsor ID
- FLU003 / FLU003
- Conditions
- Influenza
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Vaxine Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Flinders University, Australian Respiratory and Sleep Medicine Institute
- Study start
- Jul 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 9 Jan 2015 (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.
Recombinant hemagglutinin has been shown to induce protective neutralising antibodies against avian influenza virus but is relatively non-immunogenic. An ideal pandemic avian influenza influenza vaccine would combine hemagglutinin antigen with an appropriate adjuvant to increase its immunogenicity. This Phase 1 study will collect preliminary human safety and efficacy data on combined formulations of recombinant hemagglutinin with Advax adjuvant formulations administered by intramuscular injection
Detailed description
This is a study to test new vaccine formulations against pandemic avian influenza ("bird flu"). Bird flu is a potentially deadly disease that is caused by influenza virus from birds. It is not the same as the common seasonal flu for which there is a seasonal vaccine released around March each year. To date, bird flu due to the H5N1 strain of influenza virus has infected over 500 people mainly in Asia resulting in death in more than half the cases. More recently there has been an outbreak of another bird flu virus in China known as H9N7 that is also highly lethal when it infects humans. Vaccination is the single most effective measure to prevent infection from bird flu viruses such as H5N1 or H9N7 should such a pandemic occur. In the event of a major bird flu pandemic outbreak, vaccine supplies are likely to be very limited, as there is not currently sufficient manufacturing capacity to provide enough vaccine quickly for the whole population. Research is needed on how to make the pandemic flu vaccine more effective but also how to stretch vaccine supplies using a strategy called 'antigen-sparing'. This can potentially be achieved by using an important ingredient called an 'adjuvant'. Adjuvants act by stimulating the immune system to make vaccines more effective. This study will test Advax adjuvants which are based on delta inulin in combination with recombinant hemagglutinin from the H5N1 influenza virus serotype.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| HA 45ug | Experimental | Biological: recombinant influenza hemagglutininrecombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses |
| HA 45ug+Advax1 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax1recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses |
| HA 45ug+Advax2 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax2recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses |
| HA 15ug+Advax1 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax1recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses |
| HA 15ug+Advax2 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax2recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses |
| HA 5ug+Advax1 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax1recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses |
| HA 5ug+Advax2 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax2recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses |
| HA 2.5ug+Advax2 | Experimental | Biological: recombinant influenza hemagglutinin, Biological: Advax2recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses |
| HA 15ug | Experimental | Biological: recombinant influenza hemagglutininrecombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ambulatory males or females aged 18 years and over
- Able to provide written informed consent
- Willing and able to comply with the protocol for the duration of the study.
- Not planning to have seasonal influenza vaccine within 2 months from the time of the first trial immunization
Key exclusion criteria (4 listed)
- Pregnant or lactating women.
- Women of childbearing potential unless using a reliable and appropriate contraceptive method.
- Receipt of another investigational agent within 28 days preceding initiation of treatment.
- Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
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 |
|---|---|---|
| recombinant influenza hemagglutininrecombinant influenza hemagglutinin | Biological | HA 15ug, HA 15ug+Advax1, HA 15ug+Advax2, HA 2.5ug+Advax2, HA 45ug, HA 45ug+Advax1, HA 45ug+Advax2, HA 5ug+Advax1, HA 5ug+Advax2 |
| Advax1Delta inulin adjuvant formulation 1 | Biological | HA 15ug+Advax1, HA 45ug+Advax1, HA 5ug+Advax1 |
| Advax2Delta inulin adjuvant formulation 2 | Biological | HA 15ug+Advax2, HA 2.5ug+Advax2, HA 45ug+Advax2, HA 5ug+Advax2 |
Primary outcome
The incidence of adverse events
Time frame: 12 months
The frequency of adverse events will be compared between groups
1 secondary outcome
Hemagglutination inhibition assay
Time frame: 1 month post each immunization and 11 months post final immunization
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 7 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Dimitar Sajkov, FRACP, PhD principal investigator
Flinders University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant influenza hemagglutinin, Advax1 and Advax2 in people with Influenza, run by Vaxine Pty Ltd at 1 site in Australia.
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 4 inclusion and 4 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 May 2019. 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 Australia. 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 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.
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?
The incidence of adverse events (time frame: 12 months). 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 7 May 2019.