Comparing Immunisation-Boosting Regimens for COVID-19 Upon Initiation of immunosuppressive Therapies (CIRCUIT) Study

Research program:

Biostatistics and Databases Program

Immunovirology and Pathogenesis Program

Infection Analytics Program

Therapeutic and Vaccine Research Program

Viral Immunology Systems Program

Currently recruiting:

Yes

The challenge:

We know that patients on moderate to severe forms of immunosuppressive therapy can have less that optimal responses to COVID-19 vaccine boosters. Few studies have investigated the best time to give vaccine boosters in people facing new immunosuppression, for example as part of treatment for haematological malignancies or autoimmune/inflammatory conditions.

The project:

The CIRCUIT Study is a Randomised Control Trial (RCT) of people with haematological malignancies or autoimmune/inflammatory condition commencing immunosuppressive therapy for the first time. Study participants will be randomised to receive a COVID-19 booster vaccine either prior to the onset of immunosuppression OR 6 months-post immunosuppression, when the most intensive phase of therapy is complete. A diphtheria-tetanus booster vaccine will be studied as a comparator booster vaccine.

The method:

The CIRCUIT Study involves a collaborative research network, with participants being invited to participate from Blacktown, Westmead, Concord, St Vincent's Hospital and Royal Prince Alfred Hospitals being invited to participate.

The results:

The CIRCUIT Study will measure the COVID-19 booster vaccine response using a live-virus neutralization assay at timepoints over a one-year period. At the end of the study period, these measurements will determine if greater protection from COVID-19 disease is provided by administering the booster vaccine just prior to immunosuppression OR if there is higher protection by providing the booster vaccine 6 months after the onset of immunosuppression. This question has not been well answered to-date.

The impact:

The CIRCUIT Study will provide important information on vaccine booster timing around the commencement of moderate to severe immunosuppression. This will be relevant to COVID-19 vaccines but also to more traditional forms of vaccine e.g. the diphtheria-tetanus vaccine. The ultimate goal of the CIRCUIT Study is to provide a rational evidence base to inform future national vaccination guidelines for at-risk groups.

Project contact: