None listed
Conditions
Brief summary
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.
Interventions
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
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.
Sponsors
PathWest Laboratory Medicine WA
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
Yes
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
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).
Outcome results
None listed