SARS-CoV-2 (COVID-19) vaccination and the immune responses in patients with haematological malignancy and other immune deficiency.

Not Applicable

Recruiting

• Conditions: Haematological malignancy; Immunosuppression; COVID-19; Blood - Haematological diseases; Cancer - Leukaemia - Chronic leukaemia; Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma; Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma; Cancer - Myeloma; Inflammatory and Immune System - Other inflammatory or immune system disorders

• Registration Number: ACTRN12622001509752
• Lead Sponsor: The Perth Blood Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-05
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Age > or = 18.
• Are eligible to receive or have received at least 3 doses of the standard of care SARS-COV-2 vaccine as per current Australian Government Therapeutic Goods Administration Vaccine Guidelines. Currently in Australia vaccines choices include Astra Zeneca (ChAdOx1), Pfizer (BNT162b2) Moderna (mRNA -1273) and Novavax.
• Patients with haematology disorders including CLL (Chronic lymphocytic leukemia), lymphoma, other B cell lymphoproliferative disorders, myeloma, MGUS (Monoclonal gammopathy of undetermined significance), myeloproliferative disorders and other immunosuppressed patients.
• Patients who present to primary care without haematological disorders who have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines.
• Able and willing to provide Written and Informed Consent.

Exclusion Criteria

• People with vaccine allergies.
• Pregnant or breast-feeding woman.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Determine the strength of the IgG response to receptor binding domain (RBD) of the S1 subunit of the spike protein of SARS-CoV-2 from blood samples collected in immunocompromised haematology patients overtime and compare to matched controls.[For Group A and B:<br>- A single blood sample will be collected between Day 30 to 120 post 3 or 4th vaccine<br>-A single blood sample will be collected up to 6 months before further additional booster vaccination<br>- A single blood sample will be collected between Day 30 to 120 post 4 or 5th vaccine<br><br>For sub group 1a<br>- A single pre-vaccination sample will be collected up to 7 days prior to Evusheld administration.<br>- A single blood sample will be collected between Day 20-30 post Evusheld]