- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02335164
A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults (FLU003)
May 6, 2019 updated by: Vaxine Pty Ltd
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
270
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
South Australia
-
Adelaide, South Australia, Australia, 5042
- Flinders University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HA 45ug
recombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
|
Experimental: HA 45ug+Advax1
recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 1
|
Experimental: HA 45ug+Advax2
recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 2
|
Experimental: HA 15ug+Advax1
recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 1
|
Experimental: HA 15ug+Advax2
recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 2
|
Experimental: HA 5ug+Advax1
recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 1
|
Experimental: HA 5ug+Advax2
recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 2
|
Experimental: HA 2.5ug+Advax2
recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
Delta inulin adjuvant formulation 2
|
Experimental: HA 15ug
recombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses
|
recombinant influenza hemagglutinin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of adverse events
Time Frame: 12 months
|
The frequency of adverse events will be compared between groups
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemagglutination inhibition assay
Time Frame: 1 month post each immunization and 11 months post final immunization
|
Seroconversion, seroprotection and GMT fold increase will be compared between groups at each time point using hemagglutination inhibition titers
|
1 month post each immunization and 11 months post final immunization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasmablast response
Time Frame: 7 and 28 days post each immunization
|
The size of the plasmablast response will be compared between groups as an experimental endpoint
|
7 and 28 days post each immunization
|
T-cell response
Time Frame: 7 and 28 days post each immunization
|
The size of the memory T cell response will be compared between groups as an experimental endpoint
|
7 and 28 days post each immunization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Dimitar Sajkov, FRACP, PhD, Flinders University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2015
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
January 4, 2015
First Submitted That Met QC Criteria
January 6, 2015
First Posted (Estimate)
January 9, 2015
Study Record Updates
Last Update Posted (Actual)
May 7, 2019
Last Update Submitted That Met QC Criteria
May 6, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Flu003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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