None listed
Conditions
Brief summary
The aim of this study is to assess the immune response to the SARS-CoV-2 vaccines and the prevalence of antibodies (anti-PF4) associated with development of a rare complication of SARS-CoV-2 vaccination, thrombotic thrombocytopaenia syndrome, in patients with blood cancers compared to an elderly control population from primary care. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a haematological disorder (including chronic lymphocytic leukaemia, lymphoma, other B cell lymphoproliferative disorders, myeloma, monoclonal gammopathy of undetermined significance, and myeloproliferative disorders) or are immunosuppressed, and are eligible to receive or have received at least 3 doses of an intramuscular SARS-CoV-2 vaccine (including Astra Zeneca (ChAdOx1), Pfizer (BNT162b2) Moderna (mRNA -1273) and Novavax) or the subcutaneous vaccine (Evusheld) as per current Australian Government Vaccine Guidelines. You may also be eligible for this study if you are aged 18 years or older, presenting to primary care without haematological disorders and have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines. Study details All participants will undergo SARS-CoV-2 vaccination in accordance with Australian Government Vaccine Guidelines. For those receiving intramuscular vaccination, a single blood sample for the assessment of immune response and antibody formation will be collected between Days 30 to 120 post 3rd or 4th vaccination, 6 months post 3rd or 4th vaccination (or immediately prior to additional booster vaccination), and between Days 30 to 120 post 4th or 5th vaccination. For those receiving subcutaneous vaccination, a single blood sample will be collected up to 7 days prior to vaccination and at Days 20 and 30 post-vaccination. At these timepoints, clinical reviews will also be undertaken to determine haematological malignancy diagnosis, baseline characteristics of independent variables (e.g., previous treatments) and blood parameters (e.g., full blood count). It is hoped that this study may help to determine the immune response to the SARS-CoV-2 vaccination in this vulnerable group of patients, and will inform formulation of guidelines and treatment protocols for SARS-CoV-2 infection in the general population and immunosuppressed haematology patients.
Interventions
This is an observational Cohort study to assess the immune response to the SARS-CoV-2 vaccination and the prevalence of clotting related antibodies in hematology and other immunosuppressed patients.
Participants in this study will be assigned to one of the following groups:
- Group A: Patients with haematology and other immunosuppressed conditions who have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines.
- Subgroup 1a: Immuno-suppre
This is an observational Cohort study to assess the immune response to the SARS-CoV-2 vaccination and the prevalence of clotting related antibodies in hematology and other immunosuppressed patients. Participants in this study will be assigned to one of the following groups: - Group A: Patients with haematology and other immunosuppressed conditions who have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines. - Subgroup 1a: Immuno-suppressed haematology patients in Group A who have received or eligible to receive standard of care Australian Government Therapeutic Goods Administration approved COVID prevention subcutaneous injection (Evusheld - Cilgavimab and Tixagevimab) according to the WA Health Department Guidelines. - Group B: General Population patients without haematological disorders who have received at least 3 doses of SARS-COV-2 vaccination according to Australian Government Vaccine Guidelines. After informed consent, demographic and clinical information (Disease history for immunocompromised patients only, general medical history, concomitant medications, COVID-19 vaccination status/virus positivity status and vital signs) will be collected at registration and blood taken Day 30 to 120 post 3 or 4th vaccine for initial measurement of established protective antibody response. At 6 months or before further additional booster vaccination further clinical review (Disease history for immunocompromised patients only, concomitant medications, COVID-19 vaccination status/virus positivity status and vital signs) and blood draw to measure of the duration of the protective antibody response. A third blood sample will be taken Day 30 to 120 post 4 or 5th vaccine to measure of protective antibody response after next vaccination. In the eligible immunosuppressive haematology patients receiving Evusheld (Cilgavimab and Tixagevimab), a pre vaccination blood test and a day 30 post injection blood test in addition will be taken. Frequency of Blood sample collection- For Group A and B: - A single blood sample will be collected between Day 30 to 120 post 3 or 4th vaccine -A single blood sample will be collected up to 6 months before further additional booster vaccination - A single blood sample will be collected between Day 30 to 120 post 4 or 5th vaccine For sub group 1a - A single pre-vaccination sample will be collected up to 7 days prior to Evusheld administration. - A single blood sample will be collected between Day 20-30 post Evusheld As of the current guidelines, the participants will receive 4 vaccinations; but this may change according to the standard COVID-19 vaccination guidelines in the future.
Sponsors
The Perth Blood Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Outcome results
None listed