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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05415267




Registration number
NCT05415267
Ethics application status
Date submitted
8/06/2022
Date registered
13/06/2022
Date last updated
15/03/2024

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
Other interventions - diphtheria and tetanus toxoids (adsorbed) vaccine
Other interventions - 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


Other interventions: 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.

Other interventions: 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
Other interventions
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 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
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.

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
Other
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
It is important people receiving immunosuppressive therapy are provided with the best
protection against COVID-19 because they are at greater risk of severe illness should they
become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination,
doctors agree that COVID-19 boosters is are important to maximise the vaccine response in
these people. However, we don't currently know the best time to give booster vaccines to
people about to start immunosuppressive therapy. This research aims to address this knowledge
gap by examining whether the greatest protection is provided by giving the COVID-19 booster
just before the immunosuppressive therapy starts or by waiting and giving the booster 6
months after treatment start. At the 6-month timepoint, in many cases the more intensive
immunosuppression is often weaning and the immune system is starting to rebuild.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05415267
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarah 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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05415267