This site is now managed by the Commonwealth Department of Health and Aged Care. 

Australian Clinical Trials

Clinical Trial Details

Influenza vaccination strategies in haematological cancers

Print record Print record
Trial Information

Broad Health Condition Infection
Cancer
Cancer
Cancer

Specific Health ConditionOther infectious diseases
Myeloma
Leukaemia - Chronic leukaemia
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Trial FocusPrevention

Recruitment Details

Recruitment status
Recruiting

Recruitment State
VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne
Austin Health - Austin Hospital - Heidelberg

Postcode
3000 - Melbourne
3084 - Heidelberg

Anticipated date of first participant enrolment1/04/2022

Anticipated date of last participant enrolment31/10/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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 2022.

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.

Eligibility

Key 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

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key 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. 
Contact details and further information

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Peter MacCallum Cancer Centre
Primary Sponsor Address: 305 Grattan Street, VIC 3000, Melbourne
Primary Sponsor Country: Australia

Trial IDACTRN12622000454774

Contact person for information and recruitmentMr
Chhay Lim
305 Grattan Street, VIC 3000, Melbourne Peter MacCallum Cancer Centre
+61 3 8559 8784

Email contact Further information iconChhay.Lim@petermac.org

Australia