Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001004853
Ethics application status
Approved
Date submitted
25/06/2021
Date registered
30/07/2021
Date last updated
28/02/2023
Date data sharing statement initially provided
30/07/2021
Date results information initially provided
28/02/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The SerOzNET study seeks to better understand the safety and efficacy of the COVID-19 vaccines in people with cancer.
Scientific title
SARS CoV-2 post COVID-19 vaccine surveillance studies in Australian children and adults with cancer
Secondary ID [1] 304622 0
RES-21-0000337A
Universal Trial Number (UTN)
Trial acronym
SerOzNET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 322544 0
Oncology 322545 0
COVID-19 322651 0
Condition category
Condition code
Cancer 320172 320172 0 0
Any cancer
Cancer 320173 320173 0 0
Leukaemia - Chronic leukaemia
Cancer 320174 320174 0 0
Myeloma
Cancer 320175 320175 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 323776 323776 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
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.
Intervention code [1] 320973 0
Not applicable
Comparator / control treatment
Reference comparator- age matched, healthy control subjects.
Control group
Active

Outcomes
Primary outcome [1] 328056 0
Serological response post COVID-19 vaccination in patients with cancer.
Timepoint [1] 328056 0
Pfizer schedule for blood collection: baseline, weeks 3 & 7, then again 3 and 6 months post boost.

Astra Zeneca: baseline, weeks 3 & 12, then 1 month post boost (week 16) and 3 months post boost (week 24).

6 months post vaccination.
Primary outcome [2] 328057 0
Immunological response to COVID-19 vaccination will be assessed from collected blood samples in patients with cancer.
Timepoint [2] 328057 0
Timepoints:
Pfizer schedule for blood collection: baseline, weeks 3 & 7, then again 3 and 6 months post boost.
Astra Zeneca: baseline, weeks 3 & 12, then 1 month post boost (week 16) and 3 months post boost (week 24).
Secondary outcome [1] 397381 0
Assess vaccine hesitancy using COVID-19 vaccine-specific Oxford scale (Freeman et al, 2020)
Timepoint [1] 397381 0
6 months post final COVID-19 vaccination.

Eligibility
Key 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)
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Six cohorts:
• 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

Within each of the 6 cohorts of interest, each with a maximum of 100 participants (or 6 months after opening), the study is powered to have over 80% power to detect a decrease of 10% seroconversion rate in any cancer cohort (compared with assumed non-cancer population incidence of 95%) with 95% confidence.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/06/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
31/08/2022
Date of last data collection
Anticipated
29/12/2023
Actual
31/01/2023
Sample size
Target
500
Accrual to date
Final
510
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 19804 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 19805 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [3] 19806 0
Dandenong Hospital - Dandenong
Recruitment hospital [4] 19807 0
Casey Hospital - Berwick
Recruitment hospital [5] 20842 0
Sydney Children's Hospital - Randwick
Recruitment hospital [6] 20843 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [7] 20844 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 20845 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 35669 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 35667 0
2031 - Randwick
Recruitment postcode(s) [3] 35668 0
2145 - Westmead
Recruitment postcode(s) [4] 34454 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 34453 0
3168 - Clayton
Recruitment postcode(s) [6] 34455 0
3175 - Dandenong
Recruitment postcode(s) [7] 34456 0
3806 - Berwick
Recruitment postcode(s) [8] 35670 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 308983 0
Government body
Name [1] 308983 0
Cancer Australia
Country [1] 308983 0
Australia
Funding source category [2] 311552 0
Government body
Name [2] 311552 0
Victorian Cancer Agency
Country [2] 311552 0
Australia
Funding source category [3] 311553 0
Charities/Societies/Foundations
Name [3] 311553 0
The Leukaemia Foundation
Country [3] 311553 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 309919 0
None
Name [1] 309919 0
None
Address [1] 309919 0
None
Country [1] 309919 0
Other collaborator category [1] 281875 0
Other
Name [1] 281875 0
The Kirby Institute
Address [1] 281875 0
Wallace Wurth Building
High St
Kensington NSW 2052
Country [1] 281875 0
Australia
Other collaborator category [2] 281876 0
Other
Name [2] 281876 0
QIMR Berghofer Research Institute
Address [2] 281876 0
300 Herston Road
Herston QLD 4006
Country [2] 281876 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308874 0
Monash Human Research & Ethics Committee
Ethics committee address [1] 308874 0
Research Support Services
Monash Health
Level 2, i Block
Monash Medical Centre
Clayton VIC 3168
Ethics committee country [1] 308874 0
Australia
Date submitted for ethics approval [1] 308874 0
03/06/2021
Approval date [1] 308874 0
22/06/2021
Ethics approval number [1] 308874 0
RES-21-0000337A

Summary
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).
Trial website
https://www.canceraustralia.gov.au/SerOzNET-Study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112182 0
Prof Eva Segelov
Address 112182 0
Monash Health & Monash University
240 Clayton Rd
Clayton VIC 3168
Country 112182 0
Australia
Phone 112182 0
+61385722392
Fax 112182 0
+6139594 3982
Email 112182 0
PAtoProfSegelov@monashhealth.org
Contact person for public queries
Name 112183 0
Ms Luxi Lal
Address 112183 0
Monash Health
MHTP Clinical Trial Centre
246 Clayton Rd
Clayton VIC 3168
Country 112183 0
Australia
Phone 112183 0
+61428803521
Fax 112183 0
+6139594 3982
Email 112183 0
seroznet@monashhealth.org
Contact person for scientific queries
Name 112184 0
Prof Eva Segelov
Address 112184 0
Monash Health & Monash University
240 Clayton Rd
Clayton VIC 3168
Country 112184 0
Australia
Phone 112184 0
+61385722392
Fax 112184 0
+6139594 3982
Email 112184 0
seroznet@monashhealth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval  seroznet@monashhealth.org
Study protocol https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-021-07019-1 


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for SARS-CoV-2 post-vaccine surveillance study in Australian adults and children with cancer: an observational study of safety and serological and immunological response to SARS-CoV-2 vaccination (SerOzNET).2022https://dx.doi.org/10.1186/s12879-021-07019-1
EmbaseRapid startup of a clinical trial due to clinical urgency of the COVID-19 pandemic: Lessons for future research.2021https://dx.doi.org/10.1111/ajco.13716
Embase1611P Clinical determinants of SARS-CoV-2 vaccine response in adults with cancer.2022https://dx.doi.org/10.1016/j.annonc.2022.07.1704
EmbaseCOVID-19 vaccinations for patients with cancer: many remain unvaccinated despite having priority in the vaccine rollout.2021https://dx.doi.org/10.1111/imj.15497
N.B. These documents automatically identified may not have been verified by the study sponsor.