The ComFluCOV study: Leading to national and international policy decisions to co-administer COVID-19 and flu vaccines
ComFluCOV is a randomised controlled trial designed to determine the safety, and the immune responses, of administering COVID-19 vaccines at the same time as flu vaccines. This study was completed within months from first conversation in March 2021. A preliminary report on the primary safety outcome was submitted to the UK Government within 3 months and the study was published in September 2021. It informed the UK and World Health Organisation (WHO) immunisation policy, showing it is safe to receive the influenza vaccine at the same time as a COVID vaccination. Implementation of this practice is underway where feasible in the UK, making delivery of vaccinations more efficient and reducing the number of appointments required.
The ComFluCOV study was designed and delivered by the Bristol Trials Centre in collaboration with the Chief Investigator, Rajeka Lazarus and the sponsorship team at University Hospitals Bristol and Weston NHS Foundation Trust. This trial was conducted across 12 locations across the UK, with 679 participating. Full Results are available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02329-1/fulltext
The ComFluCOV study was presented at the South West Research Hub on 16/06/2022 and at the Infection and Immunity Research Network Annual Symposium on Vaccines: Discovery to Uptake on 21/06/2022.
Funder acknowledgement: This trial was funded by the National Institute for Health Research Policy Research Programme (PR-R17-0916-22001, NIHR203243). The views in this Article are those of the authors and not necessarily those of the UK Department of Health and Social Care.
CORTISOL 2 Study Results
Cortisol is a steroid hormone that the body produces naturally in pulses throughout the day. Cortisol has several functions, one of which is to protect the body against an uncontrolled inflammatory response. It is thought that some critically ill patients may produce different amounts of cortisol and doctors often give them synthetic cortisol drugs to help regulate inflammation and reduce illness.
CORTISOL 2 looked at 23 patients who became critically ill after cardiac surgery (admitted to the Intensive Care Unit) and measured their cortisol levels every 10 minutes for 24 hours. It found that cortisol levels go up and down (pulsatile) like in healthy subjects, but generally at a higher level. 7 patients recorded a level of cortisol that is below the threshold for deficiency, but due to the pulsatile nature of cortisol levels the values shortly before and after would have been above the threshold. This is important as it shows that taking a one-off cortisol measurement is unhelpful in diagnosing cortisol deficiency in critically ill patients, as cortisol levels will rise and fall naturally over a 24-hour period. The results from this study may help doctors decide how to treat patients after cardiac surgery. It highlights the need for frequent blood sampling to determine true cortisol levels, and therefore individual patient requirement for synthetic cortisol.
This study was supported by a project grant from the British Heart Foundation (PG/14/72/31080) and the UK NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the review authors and not necessarily those of the NHS, the NIHR or the UK Department of Health and Social Care.