None listed
Conditions
Brief summary
This study will compare the level of protection afforded by two different influenza vaccination strategies in patients who have undergone autologous haematopoietic stem cell transplantation. Who is it for? You may be eligible to join this study if you are aged at least 18 years, have received an autologous haematopoietic stem cell transplantation (autoHSCT) within the last 12 months, and have not received an influenza vaccine for the 2019 season following your transplant. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive a new two dose strategy, which consists of the trivalent high dose influenza vaccine followed by a second dose of quadrivalent standard dose influenza vaccine one month later. Participants in the other group will receive the current standard two dose strategy of quadrivalent influenza vaccine one month apart. All vaccines will be administered by injection into the muscle. All participants will be required to provide blood samples at four time points: 1) before first influenza vaccination, 2) before second influenza vaccination; 3) 21-28 days post-second-vaccination; and 4) approximately 6 months post-vaccination. They will also be asked to provide information on vaccination history, side effects and occurrence of influenza-like illnesses (ILI). Participants who develop respiratory symptoms during the study period will be asked to provide a nasal swab. Findings may assist in improving vaccine responses and protection from influenza in a highly vulnerable patient group
Interventions
Influenza vaccination (intramuscular injections) comparing a new two dose strategy using the trivalent high dose influenza vaccine (HD) followed by a second dose of quadrivalent standard dose (SD) influenza vaccine one month later (HD-SD, Arm 1) and the current standard two dose strategy of quadrivalent influenza vaccine one month apart (SD-SD, Arm 2). Each dose is a 0.5 mL intramuscular injection into the deltoid muscle. Annual seasonal influenza vaccination is currently recommended for patient
Influenza vaccination (intramuscular injections) comparing a new two dose strategy using the trivalent high dose influenza vaccine (HD) followed by a second dose of quadrivalent standard dose (SD) influenza vaccine one month later (HD-SD, Arm 1) and the current standard two dose strategy of quadrivalent influenza vaccine one month apart (SD-SD, Arm 2). Each dose is a 0.5 mL intramuscular injection into the deltoid muscle. Annual seasonal influenza vaccination is currently recommended for patients following autoHSCT within 12 months of tranpslant. At Peter MacCallum Cancer Centre (PMCC), patients commence a program of re-vaccination at 6 months post-autoHSCT. This includes two doses of seasonal influenza vaccine (separated by 4 weeks) if they have not received this by 6 months post-transplant. Quadrivalent standard dose vaccine (FluQuadri) contains 60 micrograms (µg) haemagglutinin (HA) per 0.5 mL dose in the recommended ratio of 15 µg HA of each of the four influenza strains. Trivalent high dose vaccine (Fluzone-HD) contains 180 micrograms (µg) haemagglutinin (HA) per 0.5mL dose in the recommended ration of 60(µg) HA of each of the three influenza strains. Throughout the study, patients will be sent a weekly short message service (SMS) asking whether they have experienced an ILI (fever with at least one acute respiratory symptom or sign) in the previous 7 days. Patients will also receive SMS reminders about any follow-up appointments. The use of SMS reminders has been shown to improve retention in research studies. The SMS reminder will include their appointment time and the location. Patients failing to attend their appointment will be contacted by phone to reschedule the appointment.
Sponsors
Peter MacCullum Cancer Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged greater than or equal to 18 years and have received autoHSCT within last 12 months. 2. Willing and able to provide a blood sample just prior to vaccination, 21-28 days post dose (2 doses) and roughly 6 months post-vaccination. 3. Has not received influenza vaccine for the 2019 season following transplantation 4. No known contraindications for influenza vaccination. 5. Not recently (within last 7 days) or currently ill, or has a fever above 38°C. 6. Willing to provide current mobile phone number for SMS reminders
Exclusion criteria
1. Known contraindication(s) for TIV (e.g. hypersensitivity to vaccine component (including eggs)). 2. Recent immunosuppressive treatment with anti-CD20 antibody, Bruton’s tyrosine kinase inhibitor (within last 6 months) 3. Recently or currently ill, or has a fever above 38°C
Outcome results
None listed