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

COVID-19 Bone Marrow Transplant Haematological Malignancy

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

Inclusion Criteria5

Greater than or equal to 18 years of age
Able to provide voluntary informed consent
Planned receipt of a COVID19 vaccine of any variety; e.g. Pfizer-BioNTech BNT162b2, AstraZeneca Oxford ChAdOx1 nCoV-19 (AZD1222), Novavax NVX-CoV2373 or ModernaTX mRNA-1273 vaccine.
Patients who have any haematological malignancy and received treatment with a B-cell targeted therapy or who have received a bone marrow transplant may be recruited to Cohort A.
Patients who do not have a diagnosis of a haematological malignancy or any other active cancer, and who have not received treatment with B cell depleting antibodies will be recruited to Cohort B. 50 patients will be recruited in total, 30 to Cohort A and 20 to Cohort B.

Exclusion Criteria3

Current diagnosis of and/or treatment for a non-haematological malignancy.
Receipt of B cell targeted therapies for Rheumatological or other non-haematological malignancy indication
Unable to provide voluntary informed consent

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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.