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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03038776




Registration number
NCT03038776
Ethics application status
Date submitted
30/01/2017
Date registered
1/02/2017
Date last updated
7/05/2019

Titles & IDs
Public title
Recombinant H7 Hemagglutinin Influenza Vaccine Trial
Scientific title
A Randomised, Controlled, Phase 1 Study in Healthy Adults to Evaluate the Immunogenicity and Safety of a Recombinant H7 Hemagglutinin Influenza Vaccine
Secondary ID [1] 0 0
FLU007
Universal Trial Number (UTN)
Trial acronym
FLU007
Linked study record

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

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

Experimental: 1 - Two i.m. administrations 4 weeks apart of recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7 antigen)

Experimental: 2 - Two i.m. administrations 4 weeks apart of recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7 antigen) + Advax-1 adjuvant

Experimental: 3 - Two i.m. administrations 4 weeks apart of recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7 antigen) + Advax-2 adjuvant

Experimental: 4 - Two i.m. administrations 4 weeks apart of T cell epitope modified recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7m antigen) antigen

Experimental: 5 - Two i.m. administrations 4 weeks apart of T cell epitope modified recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7m antigen) + Advax-1 adjuvant

Experimental: 6 - Two i.m. administrations 4 weeks apart of T cell epitope modified recombinant influenza hemagglutinin corresponding to avian H7N9 virus strain (rH7m antigen) + Advax-2 adjuvant


Other interventions: Recombinant influenza hemagglutinin
Avian H7N9 influenza vaccine
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seroconversion
Timepoint [1] 0 0
1 month post immunization
Primary outcome [2] 0 0
Seroprotection
Timepoint [2] 0 0
1 month post immunization
Primary outcome [3] 0 0
Fold rise in geometric mean titer
Timepoint [3] 0 0
1 month post immunization
Secondary outcome [1] 0 0
Safety: Frequency and severity of adverse events
Timepoint [1] 0 0
12 months post immunization
Secondary outcome [2] 0 0
T cell response
Timepoint [2] 0 0
1 month post-immunization

Eligibility
Key inclusion criteria
- Male or female

- Age 18 years or over

- Able to provide written informed consent

- Willing and able to comply with the protocol for the duration of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of serious vaccine allergy*

- History of vasculitis, Wegener's granulomatosis, narcolepsy, Guillain Barre, SLE or
other systemic autoimmune disease that in the opinion of the investigator would make
the vaccine contraindicated

- History of chronic liver disease or liver transaminases elevated more than 3xULN

- Women of childbearing potential, unless using a reliable and appropriate contraceptive
method, specifically oral contraceptive pill, IUD or mechanical barrier device.

- Pregnant or lactating women.

- Any serious medical, social or mental condition which, in the opinion of the
investigator, would be detrimental to the subjects or the study.

- Receipt of another investigational agent within 28 days preceding initiation of
treatment.

- Individuals who have a past history of potential vaccine reactions will be
assessed by the investigator, who will decide whether any past potential
vaccine-related side are sufficiently minimal to allow vaccine administration to
proceed.

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 administering 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
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2019
Sample size
Target
150
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
Australian Respiratory and Sleep Medicine Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Recombinant H7 (rH7) vaccine has been shown to be poorly immunogenic in previous human
clinical trials. This study will test approaches to improve the immunogenicity of H7 vaccine,
namely use of a three dose regimen, use of a modified H7 HA sequence from which the Tregitope
has been removed (rH7m), and inclusion of delta inulin adjuvant adjuvant in the vaccine
Trial website
https://clinicaltrials.gov/ct2/show/NCT03038776
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dimitar Sajkov, MD, PhD
Address 0 0
Flinders University/ARASMI
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03038776