ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

Please note that the ANZCTR will be unattended from Friday 18th April until Tuesday 22nd April due to the Easter long weekend. Submissions and updates will not be processed during that time.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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

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]

RES-21-0000337A

Universal Trial Number (UTN)

Trial acronym

SerOzNET

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Oncology

COVID-19

Condition category

Condition code

Cancer

Any cancer

Cancer

Leukaemia - Chronic leukaemia

Cancer

Myeloma

Cancer

Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Cancer

Children's - Leukaemia & Lymphoma

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

Reference comparator- age matched, healthy control subjects.

Control group

Active

Outcomes

Primary outcome [1]

Serological response post COVID-19 vaccination in patients with cancer.

Timepoint [1]

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]

Immunological response to COVID-19 vaccination will be assessed from collected blood samples in patients with cancer.

Timepoint [2]

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]

Assess vaccine hesitancy using COVID-19 vaccine-specific Oxford scale (Freeman et al, 2020)

Timepoint [1]

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?

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]

Monash Medical Centre - Clayton campus - Clayton

Recruitment hospital [2]

Monash Medical Centre - Moorabbin campus - East Bentleigh

Recruitment hospital [3]

Dandenong Hospital - Dandenong

Recruitment hospital [4]

Casey Hospital - Berwick

Recruitment hospital [5]

Sydney Children's Hospital - Randwick

Recruitment hospital [6]

The Children's Hospital at Westmead - Westmead

Recruitment hospital [7]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [8]

Royal Perth Hospital - Perth

Recruitment postcode(s) [1]

3168 - Clayton

Recruitment postcode(s) [2]

3165 - East Bentleigh

Recruitment postcode(s) [3]

3175 - Dandenong

Recruitment postcode(s) [4]

3806 - Berwick

Recruitment postcode(s) [5]

2031 - Randwick

Recruitment postcode(s) [6]

2145 - Westmead

Recruitment postcode(s) [7]

2010 - Darlinghurst

Recruitment postcode(s) [8]

6000 - Perth

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Cancer Australia

Address [1]

Level 14, 300 Elizabeth Street, Surry Hills NSW 2010

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Victorian Cancer Agency

Address [2]

50 Lonsdale Street Melbourne Victoria 3004

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

The Leukaemia Foundation

Address [3]

33 Flemington Rd North Melbourne VIC 3051

Country [3]

Australia

Primary sponsor type

Hospital

Name

Monash Health

Address

246 Clayton Road
Clayton VIC 3168

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Other

Name [1]

The Kirby Institute

Address [1]

Wallace Wurth Building High St Kensington NSW 2052

Country [1]

Australia

Other collaborator category [2]

Other

Name [2]

QIMR Berghofer Research Institute

Address [2]

300 Herston Road Herston QLD 4006

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash Human Research & Ethics Committee

Ethics committee address [1]

Research Support Services
Monash Health
Level 2, i Block
Monash Medical Centre
Clayton VIC 3168

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/06/2021

Approval date [1]

22/06/2021

Ethics approval number [1]

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

Prof Eva Segelov

Address

Monash Health & Monash University 240 Clayton Rd Clayton VIC 3168

Country

Australia

Phone

+61385722392

Fax

+6139594 3982

[email protected]

Contact person for public queries

Name

Luxi Lal

Address

Monash Health MHTP Clinical Trial Centre 246 Clayton Rd Clayton VIC 3168

Country

Australia

Phone

+61428803521

Fax

+6139594 3982

[email protected]

Contact person for scientific queries

Name

Eva Segelov

Address

Monash Health & Monash University 240 Clayton Rd Clayton VIC 3168

Country

Australia

Phone

+61385722392

Fax

+6139594 3982

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Ethical approval			[email protected]
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

Source	Title	Year of Publication	DOI
Embase	COVID-19 vaccinations for patients with cancer: many remain unvaccinated despite having priority in the vaccine rollout.	2021	https://dx.doi.org/10.1111/imj.15497
Embase	Rapid startup of a clinical trial due to clinical urgency of the COVID-19 pandemic: Lessons for future research.	2021	https://dx.doi.org/10.1111/ajco.13716
Embase	1611P Clinical determinants of SARS-CoV-2 vaccine response in adults with cancer.	2022	https://dx.doi.org/10.1016/j.annonc.2022.07.1704
Embase	Protocol 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).	2022	https://dx.doi.org/10.1186/s12879-021-07019-1

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically