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Trial - NCT05415267


Column Value
Trial registration number NCT05415267
Full text link
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05415267

First author
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Dianne L Carey, PhD

Contact
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

dcarey@kirby.unsw.edu.au

Registration date
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

2022-06-13

Recruitment status
Last imported at : July 27, 2023, 4 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: adult aged at least 18 years previously vaccinated with 3 (or more) doses of any licensed covid-19 vaccine who requires initiation of moderate-to-severe immunosuppression; third covid-19 vaccine dose must have been given > 3 months prior planned significant immunosuppressive therapy for at least 1 year no significant immunosuppression in the past 5 years. evidence of prior tetanus toxoid vaccination (detectable tetanus toxoid igg at screening) voluntarily given written informed consent

Exclusion criteria
Last imported at : Nov. 28, 2022, 8 a.m.
Source : ClinicalTrials.gov

pregnant or breastfeeding has underlying primary immunodeficiency has received or likely to receive intravenous/subcutaneous immunoglobulin (ivig/scig). projected treatment is likely to involve plasma exchange contraindication to receipt of sars-cov-2 vaccine intolerance of or previous allergic reaction to tetanus vaccination.

Number of arms
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Kirby Institute

Inclusion age min
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Australia

Type of patients
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

320

primary outcome
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months

Notes
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : June 14, 2022, 5:30 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Immediate BNT162b2 booster at week 0.", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Delayed BNT162b2 booster at week 24", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Immediate BNT162b2 booster at week 0 and booster of combined diphtheria toxoid/tetanus toxoid (dT vaccine) at week 24.", "treatment_id": 2522, "treatment_name": "Bnt162b2+diphtheria tetanus vaccine (dt)", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}, {"arm_notes": "dT vaccine at week 0 and deferred BNT162b2 booster at week 24.", "treatment_id": 2522, "treatment_name": "Bnt162b2+diphtheria tetanus vaccine (dt)", "treatment_type": "Rna based vaccine+non covid vaccine", "pharmacological_treatment": "Vaccine+non covid vaccine"}]