COVID-19 Clinical Trial
Official title:
Comparison of Immunity-boosting Regimens for COVID-19 Upon Initiation of Immunosuppressive Therapy
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.
Status | Recruiting |
Enrollment | 320 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Blacktown Hospital | Blacktown | New South Wales |
Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
Australia | Concord General Repatriation Hospital | Concord | New South Wales |
Australia | St Vincent's Hospital, Sydney | Darlinghurst | New South Wales |
Australia | Westmead Hospital | Westmead | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Kirby Institute | Medical Research Future Fund, Seqirus Pty Ltd, Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | anti-SARS-CoV-2 neutralising antibody (NAb) response over 12 months | Integrated time-weighted area under the curve (AUC) change from baseline in anti-SARS- CoV-2 NAb over 12 months from a SARS-CoV-2 vaccination | 48 weeks | |
Secondary | Tetanus toxoid NAb response over 12 months | Integrated time-weighted AUC change from baseline in tetanus toxoid NAb over 12 months from a diphtheria/tetanus toxoids vaccination | 48 weeks | |
Secondary | Safety of immediate versus deferred COV-19 booster vaccination | Comparison of adverse events and disease flares between immediate and deferred arms in Group 1 and Group 2 | 48 weeks | |
Secondary | Efficacy of immediate versus deferred COV-19 booster vaccination | Comparison of COVID-19 disease flares between immediate and deferred arms in Group 1 and Group 2 | 48 weeks |
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