The Western Australian COVID-19 Immunity Collaborative (WACIC) Biobank
- Conditions
- SARS-CoV-2 immunityInflammatory and Immune System - Normal development and function of the immune systemInfection - Other infectious diseases
- Registration Number
- ACTRN12621001039875
- Lead Sponsor
- PathWest Laboratory Medicine WA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 682
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
•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
•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:
oPeople within 12 months of stem cell transplant
oRenal transplant recipients and end stage kidney disease patients on dialysis
oMelanoma and Lung cancer patients on immune checkpoint inhibitors.
oBreast cancer patients on Immunotherapy
oPeople with autoimmune conditions including rheumatoid arthritis on antimetabolite medication and multiple sclerosis on B-cell suppressive medication
oHIV infection
oOther 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
Cohort 1: COVID-19 Positive Cases
Adult
•Individuals who are not capable of providing their own informed consent
Child
•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
•Individuals who are not capable of providing their own informed consent
Child
•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
•Individuals who are not capable of providing their own informed consent
Cohort 5: Immunocompromised and Immunised
•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
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. [ Ongoing, cohort follow-up and sampling to continue up to two years post recruitment.]
- Secondary Outcome Measures
Name Time Method nil[ nil]