Immunosuppression and COVID-19 Boosters

ConditionCOVID-19

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorKirby Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

diphtheria and tetanus toxoids (adsorbed) vaccine
Biological/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.
COVID-19 vaccine
Biological/Vaccine
All participants will receive a COVID-19 booster vaccination at either week 0 or week 24 depending on their randomised study arm

Treatment groups

320 Participants

are divided into 4 treatment groups

Group A: Group 1 Arm AActive comparator 2 interventions

Group B: Group 1 Arm BActive comparator 2 interventions

Group C: Group 2 Arm CActive comparator 1 intervention

Group D: Group 2 Arm DActive comparator 1 intervention

Trial outcomes

Primary outcomes

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 booster vaccination

Time frame

48 weeks

Secondary outcomes

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 booster vaccination

Time frame

48 weeks

Safety of immediate versus deferred COV-19 booster vaccination

Comparison of adverse events, disease flares and breakthrough SARS-CoV-2 infections between immediate and deferred arms in Group 1 and Group 2

Time frame

48 weeks

Efficacy of immediate versus deferred COV-19 booster vaccination

Comparison of SARS-CoV-2 antibody response between immediate and deferred arms in Group 1 and Group 2

Time frame

48 weeks

Analysis of the response to the SARS-CoV-2 booster vaccination

Breadth of NAb against SARS-CoV-2 variants of concern, kinetics of NAb over time including the response to variants of concern, and memory T cell, B cell and natural killer (NK) cell responses to peptide sets representing different domains of the of the SARS-CoV-2 spike protein

Time frame

48 weeks

Other outcomes

Level of SARS-CoV-2 protection over time

A computational biological approach will use NAb levels, the boosting and decay of SAR-CoV-2 anti-spike IgG and specific memory B, T, and NK cells responses to model protection

Time frame

48 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirby Institute

Lead sponsor

Seqirus Pty Ltd, Australia

Collaborator

Medical Research Future Fund

Collaborator

Source ClinicalTrials.gov

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