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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05415267




Registration number
NCT05415267
Ethics application status
Date submitted
8/06/2022
Date registered
13/06/2022

Titles & IDs
Public title
Immunosuppression and COVID-19 Boosters
Scientific title
Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy
Secondary ID [1] 0 0
CIRCUIT Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - diphtheria and tetanus toxoids (adsorbed) vaccine
Treatment: Other - COVID-19 vaccine

Active comparator: Group 1 Arm A - Immediate SARS-CoV-2 booster at week 0 and booster of combined diphtheria toxoid/tetanus toxoid (dT vaccine) at week 24.

Active comparator: Group 1 Arm B - dT vaccine at week 0 and SARS-CoV-2 deferred booster at week 24.

Active comparator: Group 2 Arm C - Immediate SARS-CoV-2 booster at week 0.

Active comparator: Group 2 Arm D - Delayed SARS-CoV-2 booster at week 24


Treatment: Other: diphtheria and tetanus toxoids (adsorbed) vaccine
The diphtheria/tetanus toxoids vaccine will be given to participants enrolled into Group 1 as a comparator vaccine to the mRNA COVID-19 booster vaccine with the aim of determining whether the results related to COVID-19 vaccine timing also apply to more traditional protein-based vaccines.

Treatment: Other: COVID-19 vaccine
All participants will receive a COVID-19 booster vaccination at either week 0 or week 24 depending on their randomised study arm
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months
Timepoint [1] 0 0
48 weeks
Secondary outcome [1] 0 0
Tetanus toxoid NAb response over 12 months
Timepoint [1] 0 0
48 weeks
Secondary outcome [2] 0 0
Safety of immediate versus deferred COV-19 booster vaccination
Timepoint [2] 0 0
48 weeks
Secondary outcome [3] 0 0
Efficacy of immediate versus deferred COV-19 booster vaccination
Timepoint [3] 0 0
48 weeks

Eligibility
Key inclusion criteria
* Adult aged at least 18 years
* Previously vaccinated with 2 (or more) doses of any licensed COVID-19 vaccine who requires initiation of moderate-to-severe immunosuppression; most recent COVID-19 vaccine dose must have been given > 3 months prior
* Planned significant immunosuppressive therapy for at least 1 year
* No cyclophosphamide, alemtuzumab or rituximab treatment in the past 5 years. Note: patient may have concurrent steroids with any treatments listed in protocol
* Voluntarily given written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* Patients switching immunosuppressive therapies following enrolment with an absolute lymphocyte count <0.5 x 109/L immediately prior to screening

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord General Repatriation Hospital - Concord
Recruitment hospital [4] 0 0
St Vincent's Hospital, Sydney - Darlinghurst
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2137 - Concord
Recruitment postcode(s) [4] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Seqirus Pty Ltd, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical Research Future Fund
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah C Sasson, PhD
Address 0 0
The Kirby Institute UNSW Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dianne L Carey, PhD
Address 0 0
Country 0 0
Phone 0 0
+61 2 9385 0908
Fax 0 0
Email 0 0
dcarey@kirby.unsw.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05415267