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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02335164




Registration number
NCT02335164
Ethics application status
Date submitted
4/01/2015
Date registered
9/01/2015
Date last updated
7/05/2019

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian Influenza Vaccine in Adults
Scientific title
A Randomised, Controlled, Blinded Phase 1 Study to Evaluate the Immunogenicity and Safety of a Pandemic Avian H5 Influenza Vaccine in Adults
Secondary ID [1] 0 0
FLU003
Universal Trial Number (UTN)
Trial acronym
FLU003
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - recombinant influenza hemagglutinin
Other interventions - Advax1
Other interventions - Advax2

Experimental: HA 45ug - recombinant influenza hemagglutinin (H5) 45ug, i.m. injection, 2 doses

Experimental: HA 45ug+Advax1 - recombinant influenza hemagglutinin(H5) 45ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 45ug+Advax2 - recombinant influenza hemagglutinin (H5) 45ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 15ug+Advax1 - recombinant influenza hemagglutinin (H5) 15ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 15ug+Advax2 - recombinant influenza hemagglutinin (H5) 15ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 5ug+Advax1 - recombinant influenza hemagglutinin (H5) 5ug, Advax1 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 5ug+Advax2 - recombinant influenza hemagglutinin (H5) 5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 2.5ug+Advax2 - recombinant influenza hemagglutinin (H5) 2.5ug, Advax2 adjuvant 20mg, i.m. injection, 2 doses

Experimental: HA 15ug - recombinant influenza hemagglutinin (H5) 15ug, i.m. injection, 2 doses


Other interventions: recombinant influenza hemagglutinin
recombinant influenza hemagglutinin

Other interventions: Advax1
Delta inulin adjuvant formulation 1

Other interventions: Advax2
Delta inulin adjuvant formulation 2

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The incidence of adverse events - The frequency of adverse events will be compared between groups
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Hemagglutination inhibition assay - Seroconversion, seroprotection and GMT fold increase will be compared between groups at each time point using hemagglutination inhibition titers
Timepoint [1] 0 0
1 month post each immunization and 11 months post final immunization

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian Respiratory and Sleep Medicine Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief 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. 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
Trial website
https://clinicaltrials.gov/show/NCT02335164
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dimitar Sajkov, FRACP, PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications