ActivePhase 2ACTRN12624000445572

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

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

Sponsor

University of Melbourne

Enrollment

60 participants

Start Date

Mar 8, 2024

Study Type

Interventional

Conditions

COVID-19 Influenza

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria15

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.

Exclusion Criteria10

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

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Interventions

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 intramu

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.