RecruitingACTRN12621000538842

COVID-19 Vaccine Efficacy in patients with Blood Cancer

COVID-19 Vaccine Efficacy in patients with Haematological Malignancy


Sponsor

Royal Brisbane and Women's Hospital

Enrollment

50 participants

Start Date

Apr 6, 2021

Study Type

Observational

Conditions

Summary

This study will investigate immune responses to vaccination in patients with blood cancer who have received treatments targeting specific immune cells, B cells, those who have undergone bone marrow transplantation and a group of healthy volunteers who have not been treated for blood cancer or received any immune cell treatments. Who is it for? You may be eligible for this study if you are aged 18 or older, have been diagnosed with a blood cancer (including non Hodgkin's lymphoma, myeloma, Hodgkin's and leukemia) and have received either treatment with a B-cell targeted therapy or received a bone marrow transplant, and you are planning to have a COVID-19 vaccine of any variety. A second group of adults aged 18 and older who do not have a diagnosis of blood cancer or any other active cancer, who have not received treatment with B cell depleting antibodies, and who are also planning to have a COVID-19 vaccine of any variety will also be recruited. Study details Participants who choose to enrol in this study will be asked to provide up to five blood samples, starting up to 1 week beforethe first COVID-19 vaccine dose and continuing until 6 months after the second COVID-19 vaccine dose has been administered. We will also ask to review your medical records over the 12 months after you have received the second dose and may contact you to confirm any positive COVID-19 test results. It is hoped this research will enable researchers to understand how these cancer treatments affect the immune response to COVID-19 vaccination and whether vaccination will provide effective protection in patients with blood cancers.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

People with blood cancers such as lymphoma, myeloma, and leukaemia are often treated with therapies that specifically target B cells — a type of immune cell that is central to producing antibodies. This means that after vaccination (including COVID-19 vaccines), their immune systems may not respond as strongly as those of healthy people. This study investigates exactly how much protection COVID-19 vaccination provides to these patients. You may be eligible for the blood cancer group (Cohort A) if you are 18 or older, have a blood cancer diagnosis (including non-Hodgkin's lymphoma, myeloma, Hodgkin's lymphoma, or leukaemia), have received B-cell targeted therapy or a bone marrow transplant, and are planning to receive a COVID-19 vaccine. Healthy adults without cancer or immune-depleting treatments are also being recruited to a comparison group (Cohort B). Participants provide up to five blood samples — before the first dose and up to 6 months after the second dose — so researchers can measure how well the immune system responds over time. This information is vital for guiding vaccination policy and booster recommendations for people with blood cancers.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Immune responses to COVID-19 vaccination. Five blood samples will be collected from one week prior to first vaccination until six months after the second vaccination dose. Specifically the samples ar

Immune responses to COVID-19 vaccination. Five blood samples will be collected from one week prior to first vaccination until six months after the second vaccination dose. Specifically the samples are collected at the following timepoints; 1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose) 2) 72 hours prior to or after 2ndCOVID-19 vaccination dose 3) 14-18 days (+/- 2 days) after 2ndCOVID-19 vaccination dose 4) 4-6 weeks (+/- 1 week) after 2ndCOVID-19 vaccination dose 5) 6 months (+/- 2 weeks) after 2ndCOVID-19 vaccination dose Medical information regarding diagnosis and treatment will also be collected, and will include inquiring about any subsequent COVID-19 infection for 12 months after the second vaccination. 30 patients who have received treatment with B cell depleting therapies or bone marrow transplantation will be recruited from within cancer care populations and a control group of 20 patients without a cancer diagnosis or treatment will also be recruited.


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12621000538842


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