ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

The Cannon Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

Influenza

Condition category

Condition code

Infection

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]

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]

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]

Day 28 post-vaccination

Secondary outcome [1]

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]

once at day 6 post vaccination

Secondary outcome [2]

The fold difference in the post-vaccination haemagglutination inhibition (HAI) titre to individual related circulating influenza strains

Timepoint [2]

Day 28 post vaccination

Secondary outcome [3]

Fold-rise in HAI responses to the 3 Influenza vaccine strains (H1N1, H3N2 and B/Victoria) based on a paired analysis

Timepoint [3]

Day 0 and Day 28 post vaccination

Secondary outcome [4]

The fold difference in the post-vaccination haemagglutination inhibition (HAI) titre to the non-circulating B/Yamagata vaccine influenza strain

Timepoint [4]

Day 28 post vaccination

Secondary outcome [5]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Central Human Research Ethics Committee

Ethics committee address [1]

https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

09/02/2024

Ethics approval number [1]

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

Prof Stephen Kent

Address

The Peter Doherty Institute for Infection and Immunity 792 Elizabeth Street Melbourne, VIC 3000

Country

Australia

Phone

+61 03 8344 9939

Fax

skent@unimelb.edu.au

Contact person for public queries

Name

Jennifer Audsley

Address

The Peter Doherty Institute for Infection and Immunity 792 Elizabeth Street Melbourne, VIC 3000

Country

Australia

Phone

+61 03 8344 3266

Fax

jennifer.audsley@unimelb.edu.au

Contact person for scientific queries

Name

Stephen Kent

Address

The Peter Doherty Institute for Infection and Immunity 792 Elizabeth Street Melbourne, VIC 3000

Country

Australia

Phone

+61 03 8344 9939

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
21902	Study protocol			skent@unimelb.edu.au
21903	Ethical 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.

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