COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621000532808.aspx

Prof Toby Coates

toby.coates@sa.gov.au

2021-05-06

Not recruiting

nonRCT

Non-randomized

Parallel

Not reported

single-center

Prevention

For patient group: Have a current kidney transplant >3 months or currently on dialysis. Have a close household contact able to participate.

For patient group: Prior exposure to SARS-CoV-2 (positive serology). Have previously received a COVID-19 vaccination. Due to receive a transplant within the ensuing 6 months. Control/comparison group: Prior exposure to SARS-CoV-2 (positive serology). Have previously received a COVID-19 vaccination.

2

Central Adelaide Local Health Network

18

100

Australia

High risk patients

N/A

200

Capacity of serum to neutralise SARS-CoV-2 spike protein-expressing pseudovirus will be assessed by a pseudovirus neutralisation assay.[Prior to initial vaccine dose; 20 days post initial vaccine dose; 20 days post vaccine booster dose (primary timepoint); 26 weeks post vaccine booster dose.];Detectable seroconversion of IgG against SARS-CoV-2 spike protein and receptor-binding domain will be assessed by enzyme-linked immunosorbent assay. [Prior to initial vaccine dose; 20 days post initial vaccine dose; 20 days post vaccine booster dose (primary timepoint); 26 weeks post vaccine booster dose.];SARS-CoV-2 spike protein-specific T cell response will be assessed by IFN-gamma ELISpot. [Prior to initial vaccine dose; 20 days post initial vaccine dose; 20 days post vaccine booster dose (primary timepoint); 26 weeks post vaccine booster dose.]

Not reported

[{"arm_notes": "2;12 weeks apart", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days0-21", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]