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Australian Clinical Trials

Clinical Trial Details

COVID-19 Vaccine Efficacy in patients with Blood Cancer

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Trial Information

Broad Health Condition Cancer
Cancer
Cancer
Cancer
Cancer
Cancer

Specific Health ConditionLymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Myeloma
Hodgkin's
Leukaemia - Acute leukaemia
Leukaemia - Chronic leukaemia

Trial Focus

Recruitment Details

Recruitment status
Recruiting

Recruitment State
QLD

Hospital
Royal Brisbane & Womens Hospital - Herston

Postcode
4029 - Herston

Anticipated date of last participant enrolment6/04/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial 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

Key inclusion criteria

1. Greater than or equal to 18 years of age 
2. Able to provide voluntary informed consent 
3. 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. 

Minimum age18 Years

GenderBoth males and females

Can Healthy volunteers participate? Yes

Key exclusion criteria

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

Sponsor Primary Sponsor Type: Hospital
Primary Sponsor Name: Royal Brisbane and Women's Hospital
Primary Sponsor Address: Butterfield Street HERSTON QLD 4029
Primary Sponsor Country: Australia

Trial websiteN/A

Trial IDACTRN12621000538842

Contact person for information and recruitmentDr
Andrea Henden
QIMR Berghofer Medical Research Institute 300 Herston Road HERSTON QLD 4006 and Royal Brisbane and Women's Hospital Butterfield Street HERSTON QLD 4029
+61 7 3845 3968
N/A

Email contact Further information iconandrea.henden@qimrberghofer.edu.au

Australia