For the last year and a half around 4 million people in Britain have been strongly advised to ‘shield’ because they were at a great risk of severe illness and death if they were infected with COVID-19. Many of them have conditions such as cancer, inflammatory arthritis, kidney and liver disease. Their immune system may not be working at full strength due to their illness or the treatments they are receiving for their disease. Clinically-at-risk people were among the first in the UK to be offered one of the COVID-19 vaccines.
The rapid development of vaccines for COVID-19 has been a major step forward in the battle against this disease. Vaccines work by training the body’s immune system to fight a new disease. A national vaccination programme is underway for the vaccines approved by the UK regulatory authority. Prior to approval, the vaccines were tested on healthy volunteers but questions remain as to how well these vaccines will work in patients with these chronic illnesses.
The OCTAVE Trial
The OCTAVE trial is a multi-centre, multi-disease, prospective observational cohort trial. A team of researchers from universities and hospitals in England and Scotland has begun research, known as the OCTAVE study, to discover the effectiveness of the COVID-19 vaccine in these clinically at-risk patient groups. The researchers will build on years of experience in understanding the immune system in the context of chronic conditions. OCTAVE will help inform how best to vaccinate patients with chronic conditions, and protect them from COVID-19 infection in the future.
“We urgently need to understand if patient populations with chronic conditions such as cancer, inflammatory arthritis and kidney and liver disease are likely to be well-protected by current Covid-19 vaccines. The Octave study will give us invaluable new data to help us answer questions of this kind from our patients and their families.” Iain McInnes, Vice-Principal and Head of the College of Medical, Veterinary and Life Sciences at the University of Glasgow and Chief Investigator.
About the trial
The OCTAVE study will investigate the effectiveness of COVID-19 vaccines being used in the UK in 2021. Up to 5,000 people with certain immunosuppressed conditions will be involved. Using a variety of state-of-the-art immune tests performed on blood samples taken before and/or after COVID-19 vaccination, researchers will determine patients’ COVID-19 immune response and, therefore, the likelihood that vaccines will fully protect these groups from future COVID-19 infection. Researchers have begun recruiting patients at sites across the UK, and will compare results from the study group against control groups of healthy people without underlying diseases who have also received COVID-19 vaccines.
Participants with chronic kidney conditions, chronic liver conditions, inflammatory bowel disease, cancer, rheumatic or inflammatory conditions (e.g. rheumatoid arthritis), stem cell transplant and chimeric antigen receptor (CAR) T recipients attending specialist clinics across the UK will be recruited. The aim is to recruit 150participants in each of the disease types into Group 1 (which involves looking at the immune system response to COVID-19 in great detail) and an extra 850 participants in each of the disease types into Group 2 (which will conduct more simple laboratory tests to measure immune response). We will evaluate immune response in participants following receipt of regulatory approved vaccines in the UK.
What will happen to the results of the research trial?
When the study is complete the results will be published in a medical journal. We will also make a lay summary of the result available and publicise the results via patient groups, social media and the study website.
How to get involved
For more information on how to get involved, and for a list of which hospitals are currently recruiting patients to this trial, please visit our How to get involved page.