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

Phase 2

Active, not recruiting

• Conditions: COVID-19; Influenza; Infection - Other infectious diseases

• Registration Number: ACTRN12624000445572
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-10
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 56

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.

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

• Study Type: Interventional
• Study Design: Not specified