None listed
Conditions
Brief summary
This study will investigate the serological and immune response of cancer patients to the COVID-19 vaccine Who is it for? You may be eligible to join this study if you are aged 5 and above, have not received COVID-19 vaccination, with one or more of the following criteria: • Currently on chemotherapy • Currently on immunotherapy • Currently on hormonal therapy • Received chemotherapy 6-12 months ago • Have an allergy to either a vaccine or an anticancer treatment • Have a diagnosis of multiple myeloma, CLL, or low grade lymphoma, are eligible for government COVID-19 vaccination program and willing to receive the vaccine Study details All participants in this study will have serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting) at baseline, day 7 post initial vaccination, at booster appointment, 7 days post booster and at 3 months after booster vaccination. Administration of the vaccine itself and real-time collection/assessment/management of toxicities will not form part of the SerOzNET study. Patients will receive vaccination at their usual GP clinic 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 contribute to the cancer immunology field in order to assist oncologist improve health outcomes for patients with cancer. The study involves serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting).
Interventions
Patients with cancer are eligible and recommended to receive the COVID-19 vaccination. Monash researchers on behalf of Cancer Australia are studying how well the COVID-19 vaccine works in patients with cancer, and what the side effects are.
Blood samples will be collected from participants at multiple time points- once before COVID-19 vaccination and four and twelve weeks after each additional dose, as per the current ATAGI guidelines dated 25th May 2022 (Pfizer schedule: weeks 3 & 7 then 1 and
Patients with cancer are eligible and recommended to receive the COVID-19 vaccination. Monash researchers on behalf of Cancer Australia are studying how well the COVID-19 vaccine works in patients with cancer, and what the side effects are. Blood samples will be collected from participants at multiple time points- once before COVID-19 vaccination and four and twelve weeks after each additional dose, as per the current ATAGI guidelines dated 25th May 2022 (Pfizer schedule: weeks 3 & 7 then 1 and 3 months post; Astra Zeneca schedule: weeks 3, 12 & 16 and 3 months post). Bloods will be collected at 1 month post each additional vaccination dose, per the ATAGI guidelines for COVID-19 vaccination in Australia (25 May, 2022). Participants will also be asked to complete study specific surveys, approximately 10 minutes each, at various time points. The observation period for participants is 10 months. Six distinct cohorts of participants will be enrolled: • Currently on chemotherapy- patients who are currently undergoing chemotherapy treatment for cancer. • Currently on immunotherapy- patients who are currently undergoing immunotherapy treatment for cancer. • Currently on other therapies- patients taking cancer treatments not believed to be traditionally immunosuppressive e.g. hormonal therapy • Received chemotherapy 6-12 months ago- patients who are no longer receiving chemotherapy, but ceased chemotherapy between 6-12 months ago. • Have an allergy to either a vaccine or an anticancer treatment- patients who have had a previous reaction to a PEG or polysorbate-80 containing substance. • Have a diagnosis of multiple myeloma, CLL, or low grade lymphoma- patients undergoing treatment with haematology oncology for multiple myeloma, chronic lymphocytic leukaemia or low grade lymphoma.
Sponsors
Monash Health
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 5 years or over as per ATAGI guidelines for COVID-19 vaccination (January 10, 2022) • Able to give informed consent (parent/guardian for participants < 16 years) • Eligible for government COVID-19 vaccination program and willing to receive the vaccine • Cancer diagnosis fitting one of the study cohorts (solid tumour, haematological malignancy, currently receiving chemotherapy, currently receiving immunotherapy & known allergic reaction to PEG or Polysorbate)
Exclusion criteria
• Not appropriate for serial peripheral blood collections, due to clinical reasons such as severe anaemia, poor venous access or other, as determined by the patient’s oncologist or haematologist. • Life expectancy estimated to be greater than 12 months • Individual is not able to provide informed consent • Pregnancy
Outcome results
None listed