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Trial registered on ANZCTR


Registration number
ACTRN12624000445572
Ethics application status
Approved
Date submitted
20/03/2024
Date registered
10/04/2024
Date last updated
25/04/2024
Date data sharing statement initially provided
10/04/2024
Date results information initially provided
25/04/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaulating the effect on immune responses of administering COVID-19 and influenza vaccines in the same or opposite arms on the same day: the Cannon Study
Scientific title
Evaulating the effect on immune responses of administering COVID-19 and influenza vaccines in the same or opposite arms on the same day in healthy participants: the Cannon Study
Secondary ID [1] 311779 0
None
Universal Trial Number (UTN)
Trial acronym
The Cannon Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 333286 0
Influenza 333287 0
Condition category
Condition code
Infection 329977 329977 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One dose (0.5 ml ) Moderna Omicron-XBB containing COVID-19 booster vaccine (Spikevax) and one dose (0.5ml) Seqirus/CSL quadrivalent unadjuvanted Influenza vaccine (Afluria), both administered intramuscularly. A total of 60 participants will be recruited. Participants will be randomised to receive both the COVID-19 and Influenza vaccine in either the same arm (n=30) or in opposite arms (n=30). The same arm group will get both vaccines in the non-dominant arm (left arm for right-handed people). The opposite arm group will get the Moderna Spikevax vaccine in the non-dominant arm (since this vaccine has a higher rate of local reactions) and the Seqirus/CSL Afluria Influenza vaccine in the dominant arm.. Moderna Spikevax will be administered first in both study groups.
Intervention code [1] 328231 0
Prevention
Comparator / control treatment
Opposite arm group will be the control group and same arm will be the comparator group
Control group
Active

Outcomes
Primary outcome [1] 337741 0
The fold difference in the post-vaccination haemagglutination-inhibition (HAI) titre combined to 3 Influenza vaccine strains (H1N1, H3N2 and B/Victoria) in the same arm group vs the opposite arm group.
Timepoint [1] 337741 0
Day 28 post-vaccination
Secondary outcome [1] 433079 0
Number of reported adverse events (AEs) and serious adverse events (SAEs) within 7 days after the receipt of the two vaccine doses. Common side effects from COVID-19 vaccination include a sore arm, redness or swelling of the arm, headache, a fever or tiredness for 1-2 days. Rare side effects include anaphylaxis (severe allergy) and cardiac inflammation (inflammation of the heart). Common side effects of Influenza vaccination include a sore arm, redness or swelling of the arm, tiredness, muscle aches and mild fever. Rare side effects include anaphylaxis (severe allergy) and neurologic (brain and nervous system) conditions such as Guillain-Barre syndrome.
Timepoint [1] 433079 0
once at day 6 post vaccination
Secondary outcome [2] 433080 0
The fold difference in the post-vaccination haemagglutination inhibition (HAI) titre to individual related circulating influenza strains
Timepoint [2] 433080 0
Day 28 post vaccination
Secondary outcome [3] 433081 0
Fold-rise in HAI responses to the 3 Influenza vaccine strains (H1N1, H3N2 and B/Victoria) based on a paired analysis
Timepoint [3] 433081 0
Day 0 and Day 28 post vaccination
Secondary outcome [4] 433082 0
The fold difference in the post-vaccination haemagglutination inhibition (HAI) titre to the non-circulating B/Yamagata vaccine influenza strain
Timepoint [4] 433082 0
Day 28 post vaccination
Secondary outcome [5] 433083 0
The difference in mean rise of blood neutralising antibodies to the SARS-CoV-2 Omicron XBB strain and other related strains in the vaccine in the same arm group vs the opposite arm group.
Timepoint [5] 433083 0
At day 28 post vaccination

Eligibility
Key inclusion criteria
• Healthy with no significant immunosuppressive illnesses. These include but are not limited to:
- cancer or treatment of cancer or organ transplantation
- treatment of auto-immune or inflammatory conditions such as inflammatory arthritis or inflammatory bowel disease
- use of corticosteroid, TNF inhibitor, interleukins, interferons, cyclosporine or other immunosuppressive medications
- significant renal or liver disease

• Two or more prior doses of a COVID-19 vaccine, the last dose at least 4 months prior to recruitment
• No previous significant adverse events to prior Influenza or COVID-19 vaccines, according to the criteria below. Severe grading indicates the event prevented daily activity, temperature >40.0°C or >10.0 cm in diameter for redness and swelling at the site of injection
- severe systemic events (fatigue, headache, fever, muscle or joint pain)
- severe local events (pain at injection site, redness and swelling
- any event requiring emergency department visit or hospitalisation
• No prior anaphylaxis to any cause, including to prior Influenza or COVID-19 vaccines
• No prior cardiac inflammatory condition (myocarditis, pericarditis), including to prior COVID-19 vaccine
• Willing and available to have blood, saliva and nasal fluid samples taken per the schedule of events
• Willing to be randomly assigned to receive Influenza and COVID-19 vaccines either in the same arm or opposite arms.
• Willing to provide a signed and dated informed consent form.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Prior COVID-19 infection or Influenza infection within 4 months of recruitment
• Prior COVID-19 vaccination or Influenza vaccination within 4 months of recruitment
• Pregnant or breastfeeding women and women planning to become pregnant
• Unwilling to use reliable contraception around the timing of the vaccine (one month before and one month after)
• Receiving medication that might reduce immune responses. These include but are not limited to:
- systemic corticosteroids
- interleukins
- interferons
- cyclosporine
- systemic chemotherapy

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods using minimisation to promote balance in covariates age, sex and timing of initial vaccines.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
8/03/2024
Date of last participant enrolment
Anticipated
30/04/2024
Actual
9/04/2024
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
60
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316113 0
Government body
Name [1] 316113 0
National Health and Medical Research Council
Country [1] 316113 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318290 0
None
Name [1] 318290 0
Address [1] 318290 0
Country [1] 318290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314945 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 314945 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 314945 0
Australia
Date submitted for ethics approval [1] 314945 0
Approval date [1] 314945 0
09/02/2024
Ethics approval number [1] 314945 0

Summary
Brief summary
This study is a randomised open-label trial of administering an Influenza and COVID vaccine on the same day in the same arm or in opposite arms. We will enrol healthy participants who would like to the get the Influenza vaccine and a COVID vaccine booster on the same day. We will randomise participants to receive the two vaccines to the same arm or to opposite arms on the same day and have blood, saliva and nasal fluid tests to follow their immune responses to the vaccines. partcipants have study visits prior to vaccination, day 6 post vaccination and day 28 post vaccination. We are testing the idea that receiving both vaccines the same arm may provide higher levels of immune reponses against Influenza.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133202 0
Prof Stephen Kent
Address 133202 0
The Peter Doherty Institute for Infection and Immunity 792 Elizabeth Street Melbourne, VIC 3000
Country 133202 0
Australia
Phone 133202 0
+61 03 8344 9939
Fax 133202 0
Email 133202 0
skent@unimelb.edu.au
Contact person for public queries
Name 133203 0
Jennifer Audsley
Address 133203 0
The Peter Doherty Institute for Infection and Immunity 792 Elizabeth Street Melbourne, VIC 3000
Country 133203 0
Australia
Phone 133203 0
+61 03 8344 3266
Fax 133203 0
Email 133203 0
jennifer.audsley@unimelb.edu.au
Contact person for scientific queries
Name 133204 0
Stephen Kent
Address 133204 0
The Peter Doherty Institute for Infection and Immunity 792 Elizabeth Street Melbourne, VIC 3000
Country 133204 0
Australia
Phone 133204 0
+61 03 8344 9939
Fax 133204 0
Email 133204 0
skent@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data that underlie any published results
When will data be available (start and end dates)?
Commencing 3 months after and ending 5 years following article publication
Available to whom?
Investigators whose proposed use of the data has been approved by the Cannon Study Protocol Steering Committee
Available for what types of analyses?
For individual participant meta-analysis
How or where can data be obtained?
Proposals may be submitted up to 5 years following article publication. Proposals should be directed to skent@unimelb.edu.auTo gain access data requestors will need to sign a data access agreement. Data will be available for 5 years at The University of Melbourne Research Repository which is found at:
https://melbourne.figshare.com/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21902Study protocol  skent@unimelb.edu.au
21903Ethical approval  skent@unimelb.edu.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.