Influenza vaccination strategies in haematological cancers

Not Applicable

Completed

• Conditions: Influenza vaccination; Haematological malignancy; Infection - Other infectious diseases; Cancer - Myeloma; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

• Registration Number: ACTRN12622000454774
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-23
• Study Completion: 2023-10-23
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine and compare rates of seroconversion afforded by two novel influenza vaccination strategies (Arm 1 vs. Arm 2) among patients with haematological malignancy. <br><br>Seroconversion rate is defined by percentage of samples with prevaccination HI titre that is less than 1:10 and a postvaccination HI titre that is greater than or equal to 1:40 or a prevaccination titre that is greater than or equal to 1:10 and a greater than or equal to 4-fold increase in postvaccination titre.<br><br>To achieve this outcome, serum samples will be used to measure antibody titres. Serum antibody titre will be measured by haemagglutination inhibition (HI) assay or other serology assays such as microneutralisation assays or enzyme-linked immunosorbent assays (ELISA). The assays will detect antibodies to influenza strains included in the 2022 QIV vaccine.[ Seroconversion rate at V3 (21-28 days post second dose)(Primary timepoint)<br>Seroconversion rate at V2 (21-28 days post first dose) ]