Clinical trial
Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy
Name
CIRCUIT Study
Description
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 arms
Trial start
2023-07-21
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Group 1 Arm A, Group 1 Arm B
Other names:
ADT Booster
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
Arms:
Group 1 Arm A, Group 1 Arm B, Group 2 Arm C, Group 2 Arm D
Size
320
Primary endpoint
anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months
48 weeks
Eligibility criteria
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:
* 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 320, 'type': 'ESTIMATED'}}
Updated at
2024-03-15
1 organization
1 product
Organization
Kirby Institute