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Influenza vaccination strategies in haematological cancers

A randomised trial of influenza vaccination strategies in patients with haematological malignancy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000454774
Enrollment
130
Registered
2022-03-23
Start date
2022-05-11
Completion date
2023-06-07
Last updated
2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

What is this study about? We are looking at the immune response to influenza vaccine and how this can be improved in patients during or after treatment for certain types of blood cancers. When you are vaccinated, your body makes antibodies against influenza virus, which protect you from influenza infection. We know that the body’s immune response to influenza vaccine is not as strong after treatment for blood cancer. Currently, having one dose is recommended to try to protect you against influenza. We would like to study if two adjuvant dose influenza vaccines or two standard vaccines will improve the immune response. An adjuvant vaccine is a vaccine that contains an ingredient which can stimulate a stronger immune response and is generally used in people 65 years and above. Who is it for? You may be eligible to participate in this study if you are aged 18 years or older, have been receiving treatment for blood cancer (myeloma, chronic lymphocytic leukaemia or non-Hodgkins lymphoma) or have received treatment for the listed blood cancers within the last 12 months, and have not yet received a flu vaccine for the current season of recruitment (i.e. 2022 influenza vaccine for 2022 recruitment, 2023 influenza vaccine for 2023 recruitment). Study details There will be two groups of participants and both groups will two doses of influenza vaccine, one month apart. One group (Group 1) will receive two doses of the adjuvant influenza vaccine 1 month apart and a second group (Group 2) standard dose influenza vaccine followed by the standard dose vaccine 1 month later. Blood samples will be collected at four time points: before the first vaccine, before the second vaccine, 21-28 days after the second vaccine, and 6 months after the first vaccine. Participants will also be asked to provide information on vaccination history, side effects and if an influenza-like illness (ILI) occurs. Participants will be contacted weekly to see if they have developed any influenza-like illness from first vaccination until 6 months later. If respiratory symptoms occur, the participant will be asked to give a nasal swab and get checked out by their regular treating or general practitioner. This study will help us understand if two doses of the adjuvant or standard dose vaccine should be used in patients.

Interventions

Influenza vaccination (intramuscular injection) comparing new two-dose strategies consisting of quadrivalent adjuvant influenza vaccine (Fluad Quad [AD]) followed by a second (AD) dose one month later (AD-AD, Arm 1) and quadrivalent standard dose (Afluria Quad [SD]) followed by a second SD one month later (SD-SD, Arm 2). Each dose is a 0.5 mL intramuscular injection into the deltoid muscle by the research nurse. Patients will be randomised to one of two cohorts: (AD-AD, Arm 1) or (SD-SD, Arm 2

Influenza vaccination (intramuscular injection) comparing new two-dose strategies consisting of quadrivalent adjuvant influenza vaccine (Fluad Quad [AD]) followed by a second (AD) dose one month later (AD-AD, Arm 1) and quadrivalent standard dose (Afluria Quad [SD]) followed by a second SD one month later (SD-SD, Arm 2). Each dose is a 0.5 mL intramuscular injection into the deltoid muscle by the research nurse. Patients will be randomised to one of two cohorts: (AD-AD, Arm 1) or (SD-SD, Arm 2). Patients will be vaccinated according to randomly allocated cohort to compare responses to two vaccination strategies.

Sponsors

Peter MacCallum Cancer Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male and female subjects aged greater than or equal to 18 years and currently receiving or have received within last 12 months treatment for MM, CLL and NHL. Women of child-bearing potential will need to be on adequate contraception. 2. Willing and able to provide a blood sample just prior to vaccination, 21-28 days post each dose and roughly 6 months post-vaccination. 3. Has not received influenza vaccine for the 2022 season 4. No known contraindications for influenza vaccination. 5. Willing to provide current mobile phone number for SMS reminders

Exclusion criteria

1. Known contraindication(s) for QIV (e.g. hypersensitivity to vaccine component (including eggs)). 2. Recent stem cell transplant (less than 12 months) 3. Hypogammaglobulinaemia on immunoglobulin replacement 4. Recently (within last 7 days) unwell with a fever above 38°C. 5. Prior participation in the study (i.e. during the 2022 enrolment year)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026