Perth Blood Institute (PBI) is pleased to announce the commencement of a clinical trial to assess the immune response to the SARS-CoV-2 vaccination – the COVAXI trial. The trial will include patients with existing haematological or blood disorders, inflammatory disorders and who have a compromised immune system.

The trial will also look at pre-exposure prophylactic COVID-19 medication in immunocompromised patients over a 3–4-week period. This will be achieved by assessing blood markers before and after the prophylactic medication has been administered.

COVID-19 can affect anyone; however, symptoms may vary depending on several variables – age, general health, chronic illnesses and immune system. People who have a weakened immune system (immunocompromised) have a higher risk of getting sick with COVID-19 or may have symptoms for a longer period.

The health conditions which will be studied include blood diseases, blood cancers - leukaemia, non-Hodgkin lymphoma and multiple myeloma, inflammatory and immune system disorders. COVID-19 vaccines are used to help protect people from getting seriously ill, requiring hospitalisation and dying from the virus. Individuals who are immunocompromised may require additional or alternative treatments.

There is a lot of research which has looked at the COVID-19 vaccine on healthy patients, however we are yet to identify the impact on patients with a weakened immune system. COVAXI is an independently run trial by the PBI Clinical Trials team who received ethics approval in June 2022.

Recruitment commenced in August 2022 with already 201 patients enrolled, and will end on September 1^st, 2023, with a target of 450 participants. Inclusion criteria for the trial:

• both males and females (not pregnant or breastfeeding),
• aged ≥18,
• people with a blood disorder, have a myeloproliferative disorder (rare blood cancer) or are immunocompromised, and
• are eligible for or have received 3 vaccine doses.

The trial will also use a control group comprising of healthy individuals who have received at least 3 doses of a SARS-CoV-2 vaccination.

COVAXI is such an important trial for the health of these groups of vulnerable individuals and we are very excited to see the results. We hope this study will help to inform the construction of guidelines and treatment protocols for SARS-CoV-2 infection in the general population and immunocompromised haematology patients.