Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001039875
Ethics application status
Approved
Date submitted
21/07/2021
Date registered
6/08/2021
Date last updated
4/08/2024
Date data sharing statement initially provided
6/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Western Australian COVID-19 Immunity Collaborative (WACIC) Biobank
Scientific title
The Western Australian COVID-19 Immunity Collaborative (WACIC) Biobank: a prospective bio repository of specimens and clinical data to enable research and development of diagnostic assays relevant to SARS-CoV-2 immunity.
Secondary ID [1] 304842 0
None
Universal Trial Number (UTN)
Trial acronym
WACIC Biobank
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 immunity 322929 0
Condition category
Condition code
Inflammatory and Immune System 320504 320504 0 0
Normal development and function of the immune system
Infection 320587 320587 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The WA COVID-19 Immunity Collaborative (WACIC) Biobank will establish a biobank of high-quality samples from well characterised cohorts of convalescent COVID-19 cases, their close contacts, SARS-CoV-2-negative controls, immunised people, and other populations, to support future basic science, translational and applied research, and development, optimisation and validation of diagnostic laboratory assays relevant to assessment of SARS-CoV-2 immunity.

Cohort 1 Description: COVID-19 positive cases (adults and children)
Participant visits are defined according to time from onset of symptoms of COVID-19. They will be seen for a baseline visit and then visits at the following time points:
- 14 days post-symptom onset
- 1 month post-symptom onset
- 3 months post-symptom onset
- 6 months post-symptom onset
- 12 months post-symptom onset
- 18 months post-symptom onset
- 24 months post-symptom onset
Most participants will be convalescent cases, and hence enter this study after some of the early time points have passed. In that scenario, participants will attend the Baseline visit and then commence the visit schedule from the time point that immediately precedes the date of their consent.

At each visit 1 blood sample and 1 saliva sample will be collected; adult participants will be asked to complete the International Severe Acute Respiratory and emerging Infection Consortium (ISARIC) COVID-19 Follow-up Survey; and parents/guardians of child participants will be asked to complete the ISARIC COVID-19 Paediatric Initial Follow-up Form. Their height & weight will be measured and medical history and medication data will be collected. Visits will be conducted by trained study staff (research nurse or assistant) and will take 30 minutes to an hour.

Cohort 2 Description: Close contacts (adults and children)
Participants will attend 1 visit where a blood sample and saliva sample will be taken and adult participants will be asked to complete the EQ-5D-5L questionnaire. Their height & weight will be measured and medical history and medication data will be collected. Visits will be conducted by trained study staff (research nurse or assistant) and will take 45 minutes.

Cohort 3 Description: Immunised individuals (adult and children)
Participants will be seen at the following time points:
Schedule 1*
- Baseline: up to 7 weeks prior to their first vaccine
- 28 days after first dose (where there is an interval of at least 6-8 weeks between the first and second doses of vaccine)**
- 7 days prior to second dose
- 28 days after second dose
- 3 months after second dose***
- 6 months after second dose
- 12 months after second dose
- 24 months after second dose
Schedule 2
- Up to 4 weeks prior to third dose
- 7 days after third dose**
- 28 months after third dose
- 6 months after third dose
- 12 months after third dose
- 24 months after third dose
*if participant receives a third dose of a SARS CoV-2 vaccine the schedule of visits in Schedule 1 will be replaced by the schedule of visits in Schedule 2.
**Adult participants only
***Child participants only

At each visit 1 blood sample and 1 saliva sample will be collected, and adult participants will be asked to complete an EQ-5D-5L questionnaire. Their height & weight will be measured and medical history and medication data will be collected. Visits will be conducted by trained study staff (research nurse or assistant) and will take 30 minutes to an hour.

Cohort 4 Description: Healthy Controls (Adults only)
Participants will attend 1 visit where a blood sample and saliva sample will be taken and they will be asked to complete the EQ-5D-5L questionnaire. Their height & weight will be measured and medical history and medication data will be collected. Visits will be conducted by trained study staff (research nurse or assistant) and will take 45 minutes.

Cohort 5 Description: Immunocompromised and immunised (Adults only)
Participants will be seen at the following time points:
Schedule 1*
- Baseline: up to 7 weeks prior to their first vaccine
- 7 days prior to second dose
- 28 days after second dose
- 6 months after second dose
- 12 months after second dose
- 24 months after second dose
Schedule 2
- Up to 4 weeks prior to third dose
- 7 days after third dose
- 28 months after third dose
- 6 months after third dose
- 12 months after third dose
- 24 months after third dose
*if participant receives a third dose of a SARS CoV-2 vaccine the schedule of visits in Schedule 1 will be replaced by the schedule of visits in Schedule 2.

At each visit 1 blood sample and 1 saliva sample will be collected, and they will be asked to complete an EQ-5D-5L questionnaire. The initial visit will be conducted by their treating clinician. Follow-up time points will be conducted via electronic survey and samples will be taken at a local Pathology clinic.

Intervention code [1] 321223 0
Diagnosis / Prognosis
Comparator / control treatment
SARS-CoV-2 negative ("Healthy") controls will be used to compare the immune response in those who have had a confirmed SARS-CoV-2 infection and those who have not.
Control group
Active

Outcomes
Primary outcome [1] 328335 0
To establish a biobank of high-quality samples to support future basic science, translational and applied research, and development, optimisation and validation of diagnostic laboratory assays relevant to assessment of SARS-CoV-2 immunity. This will be determined by the recruitment of the target number of participants with 70% of participant samples being collected and stored.
Timepoint [1] 328335 0
Ongoing, cohort follow-up and sampling to continue up to two years post recruitment.
Secondary outcome [1] 398631 0
nil
Timepoint [1] 398631 0
nil

Eligibility
Key inclusion criteria
Cohort 1: COVID-19 Positive Cases
Adult Inclusion Criteria:
• more than or equal to 18 years of age
• Have had a confirmed case of COVID-19 as defined by at least one PCR-positive nasopharyngeal and/or throat swab

Child Inclusion Criteria:
• less than 18 years of age
• Have had a confirmed case of COVID-19 as defined by at least one PCR-positive nasopharyngeal and/or throat swab, or be suspected to have COVID-19 based on the presence of clinical symptoms and referred for a nasopharyngeal and/or throat swab or other diagnostic test for SARS-CoV-2 infection
• Parent/guardian's consent to participate

Cohort 2: Close Contacts
Adult Inclusion Criteria:
• more than or equal to 18 years of age
• A close contact of a COVID-19 positive case, as defined by current Public Health criteria, who have either not been tested for COVID-19, or who received a negative COVID-19 test result (i.e. non-infected by PCR).

Child Inclusion criteria
• less than 18 years of age
• A close contact of a COVID-19 positive case, as defined by current Public Health criteria, who have either not been tested for COVID-19, or who received a negative COVID-19 test result (i.e. non-infected by PCR).

Cohort 3: Immunised
Adult Inclusion criteria:
• more than or equal to 18 years of age
• Are intending to receive a SARS-CoV-2 vaccine or have received one or more doses of a SARS-CoV-2 vaccine

Child Inclusion criteria:
• less than 18 years of age
• Are intending to receive a SARS-CoV-2 vaccine or have received one or more doses of a SARS-CoV-2 vaccine

Cohort 4: Healthy Controls
Adult Inclusion Criteria:
• more than or equal to 18 years of age
• Not known to have been exposed to SARS-CoV-2

Cohort 5: Immunocompromised and Immunised
Adult Inclusion Criteria:
• more than or equal to 18 years of age
• People who are immunocompromised due to their underlying disease, medical treatment or other factors, including but not limited to:
o People within 12 months of stem cell transplant
o Renal transplant recipients and end stage kidney disease patients on dialysis
o Melanoma and Lung cancer patients on immune checkpoint inhibitors.
o Breast cancer patients on Immunotherapy
o People with autoimmune conditions including rheumatoid arthritis on antimetabolite medication and multiple sclerosis on B-cell suppressive medication
o HIV infection
o Other groups of people identified as potentially immunocompromised as described in the Australian Immunisation Handbook
• Are intending to receive a SARS-CoV-2 vaccine or have received one or more doses of a SARS-CoV-2 vaccine
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cohort 1: COVID-19 Positive Cases
Adult Exclusion criteria:
• Individuals who are not capable of providing their own informed consent

Child Exclusion criteria:
• Parents/guardians and participants unable or not willing to comply with the study requirements including children with needle-phobia.
• Clinician’s assessment that study requirements is detrimental to the child.

Cohort 2: Close Contacts
Adult Exclusion Criteria:
• Individuals who are not capable of providing their own informed consent
• Anyone who has received a positive COVID-19 PCR result or serology result (these individuals will be recruited under the COVID-19 positive cohort).

Child Exclusion Criteria:
• Parents/guardians and participants unable or not willing to comply with the study requirements including children with needle-phobia.
• Anyone who has received a positive COVID-19 PCR result or serology result (these individuals will be recruited under the COVID-19 positive cohort).
• Clinician’s assessment that study requirements is detrimental to the child.

Cohort 3: Immunised
Adult Exclusion criteria:
• Individuals who are not capable of providing their own informed consent

Child Exclusion criteria:
• Parents/guardians and participants unable or not willing to comply with the study requirements including children with needle-phobia.
• Clinician’s assessment that study requirements is detrimental to the child.

Cohort 4: Healthy Controls
Exclusion criteria:
• Individuals who are not capable of providing their own informed consent

Cohort 5: Immunocompromised and Immunised
Exclusion criteria:
• Individuals who are not capable of providing their own informed consent
• Patients for whom, in the opinion of their treating consultant, donation of blood samples for this study would pose a risk of harm or side effects greater than the expected minor side effects from venepuncture (e.g. local discomfort and bruising).

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Not relevant - all analysis will be undertaken by individual projects that request access to the samples and data held within the WACIC Biobank.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/07/2021
Date of last participant enrolment
Anticipated
15/07/2023
Actual
31/12/2023
Date of last data collection
Anticipated
15/07/2024
Actual
31/12/2023
Sample size
Target
800
Accrual to date
Final
682
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 20042 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 20043 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [3] 20044 0
Royal Perth Hospital - Perth
Recruitment hospital [4] 20045 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 34750 0
6150 - Murdoch
Recruitment postcode(s) [2] 34751 0
6009 - Nedlands
Recruitment postcode(s) [3] 34752 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 309214 0
Government body
Name [1] 309214 0
Department of Health
Country [1] 309214 0
Australia
Funding source category [2] 311958 0
Charities/Societies/Foundations
Name [2] 311958 0
The Stan Perron Charitable Foundation Limited
Country [2] 311958 0
Australia
Primary sponsor type
Government body
Name
PathWest Laboratory Medicine WA
Address
Locked Bag 100, Palmyra DC, Western Australia 6961
Country
Australia
Secondary sponsor category [1] 310177 0
None
Name [1] 310177 0
Address [1] 310177 0
None
Country [1] 310177 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309066 0
South Metropolitan Health Service
Ethics committee address [1] 309066 0
Ethics committee country [1] 309066 0
Australia
Date submitted for ethics approval [1] 309066 0
23/02/2021
Approval date [1] 309066 0
12/03/2021
Ethics approval number [1] 309066 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112850 0
Dr Dominic Mallon
Address 112850 0
Clinical Immunology, Level 1
Pathology Building, Fiona Stanley
Hospital, 11 Robin Warren Drive,
Murdoch WA 6150
Country 112850 0
Australia
Phone 112850 0
+61 8 6152 8006
Fax 112850 0
Email 112850 0
dominic.mallon@health.wa.gov.au
Contact person for public queries
Name 112851 0
Sarah Miller
Address 112851 0
Clinical Immunology, Level 1
Pathology Building, Fiona Stanley
Hospital, 11 Robin Warren Drive,
Murdoch WA 6150
Country 112851 0
Australia
Phone 112851 0
+61 8 61511146
Fax 112851 0
Email 112851 0
WACIC@health.wa.gov.au
Contact person for scientific queries
Name 112852 0
Dominic Mallon
Address 112852 0
Clinical Immunology, Level 1
Pathology Building, Fiona Stanley
Hospital, 11 Robin Warren Drive,
Murdoch WA 6150
Country 112852 0
Australia
Phone 112852 0
+61 8 6152 8006
Fax 112852 0
Email 112852 0
WACIC@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All participant sample and clinical data collected during the trial will be de-identified and available to researchers.
When will data be available (start and end dates)?
3 months post commencement of recruitment. No end date determined
Available to whom?
Researchers are able to submit a Biobank access request, which will be reviewed by the WACIC Scientific Governance Committee to ensure the research proposal aligns with WACIC’s core objectives; is of a high quality and scientifically valid; has no major ethical or governance-related issues; and adheres to the privacy, confidentiality, and data and sample security requirements of the Biobank.
Available for what types of analyses?
Investigations into SARS-CoV-2 immunity (both natural and vaccine-induced)
How or where can data be obtained?
Data will be shared following ethical and governance approvals via secure file link. To obtain more information contact WACIC@health.wa.gov.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.