| Trial registration number
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ACTRN12621000661875 |
Full text link
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://anzctr.org.au/ACTRN12621000661875.aspx
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First author
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Ai Tran
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Contact
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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ai@jointswest.com.au
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Registration date
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2021-06-01
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Recruitment status
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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RCT
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Allocation
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Parallel
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Masking
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Open label
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Center
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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multi-center
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Study aim
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Prevention
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Inclusion criteria
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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• 18 years or older
• Have an autoimmune rheumatic disease or inflammatory bowel disease
• Treated and stable on immunosuppressive therapy
- Patients who do not have an autoimmune disorder and are not on immunosuppressive therapy will be included as a healthy volunteer cohort
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Exclusion criteria
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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• Prior vaccination to COVID-19
• Previous history of COVID-19 infection
• Recent prednisolone use within 4 weeks of COVID-19 vaccination
• Inability to have the COVID-19 vaccine
• Previous life threatening or end organ disease
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Number of arms
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Dr Ai Tran
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Inclusion age min
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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18
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Inclusion age max
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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Countries
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Australia
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Type of patients
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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High risk patients
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Severity scale
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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100
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primary outcome
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Antibody response to the Pfizer/BioNTech COVID-19 mRNA vaccine BNT162b2 using the COVID-19 total and IgG Siemens panel [Weeks 4 & 8 (primary timepoints) and 24];Antibody response to the Oxford/Astra Zeneca (ChAdOx1nCov-19) using the COVID-19 total and IgG Siemens panel[Weeks 4 & 16 (primary timepoints) and 24]
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Notes
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Phase 4
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Arms
Last imported at : June 12, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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[{"arm_notes": "2;weeks0-4", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;weeks0-12", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}]
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