None listed
Conditions
Brief summary
Who is it for? You may be eligible to join this study if you are planning to but yet to receive COVID-19 vaccination; or if you have received 1 dose of vaccine only, or if you are within 3 months of your second dose of COVID-19 vaccination. You may have received the Pfizer, AstraZeneca or Moderna COVID-19 vaccines. You can either be a cancer patient receiving systematic treatment including chemotherapy, immunotherapy or targeted therapy; or participate as a healthy control (if you have no history of cancer). Study details Participants in this study will undergo blood tests at up to five time-points: baseline (prior vaccination), 1 week prior to second vaccine dose, and 1, 3, and 6 months after the second dose of Covid-19 vaccine. All participants will have the 3 and 6 months post second vaccine dose sample taken. Earlier blood sample time-points will be taken where applicable (depending on when the participant enrolled in the study). Administration of the vaccine itself will not be part of part of this study. Patients will receive vaccination at their usual GP clinic, pharmacy or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice. It is hoped this research will increase knowledge of how cancer treatment affects the efficacy of vaccination, and thus contribute to the cancer immunology field and improve health outcomes for patients with cancer.
Interventions
People with cancer are at increased risk of serious health outcomes from COVID-19 infection due to their underlying cancer and/or cancer treatment. Vaccination is the current best defence against severe illness from COVID-19. However, only a small number of people with cancer were included in initial clinical trials for COVID-19 vaccines.
This study is being conducted to better understand the immune response to vaccination in people with cancer, compared with the general population. The study i
People with cancer are at increased risk of serious health outcomes from COVID-19 infection due to their underlying cancer and/or cancer treatment. Vaccination is the current best defence against severe illness from COVID-19. However, only a small number of people with cancer were included in initial clinical trials for COVID-19 vaccines. This study is being conducted to better understand the immune response to vaccination in people with cancer, compared with the general population. The study is also aimed at assessing if people with cancer remain protected in the longer term. Any impact from cancer treatment on vaccine efficacy will be assessed. Participants will have blood samples drawn at baseline prior to any COVID-19 vaccination, between their first and second dose of vaccination, then 1, 3 and 6 months following their second dose of COVID-19 vaccination. Approximately 8mL of blood will be collected in each session, taking approximately 15 minutes per session. Blood collection will be through ACT Pathology collection centres within The Canberra Region Cancer Centre (for patients) and The Canberra Hospital (for healthy controls). A study coordinator will assist in coordination of blood collection time-points. Baseline demographics on the study subjects, as well as characteristics of cancer type and treatment will be collected on the cancer patient cohort. Administration of the COVID-19 vaccine itself will not be part of this study. Patients will receive vaccination at their usual GP clinic, pharmacy, or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice.
Sponsors
The Canberra Hospital
Eligibility
Sex/Gender
All
Healthy volunteers
Yes
Inclusion criteria
1. Planning to receive the COVID-19 vaccine or received one dose of COVID-19 vaccine or within 3 months of completion of COVID-19 vaccination (received two doses of the vaccine) 2. Recipients of either the Pfizer, AstraZeneca or Moderna COVID-19 vaccines 3. Cancer patient cohort: confirmed solid tumour malignancy and: a. Receiving systemic cancer treatment: cytotoxic therapy, immunotherapy or targeted therapy within two weeks of at least one of the vaccine doses. b. Targeted therapy includes and is not limited to tyrosine kinase inhibitors e.g. imatinib, cabozantinib, pazopanib, gefitinib, osimertinib; CDK4/6 inhibitors; BRAF/MEK inhibitors c. Patients receiving hormonal therapy alone will not be eligible for the study.
Exclusion criteria
1. Beyond 3 months following receipt of second dose of COVID-19 vaccination. 2. Past laboratory confirmed diagnosis of COVID-19 infection (such as nasopharyngeal RT-PCR swab). Routine screening for COVID-19 infection beyond requirements of the local health authority is not required. 3. Concurrent diagnosis of active haematological malignancy.
Outcome results
None listed