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ComFluCOV final study results summary
Preliminary results from Bristol study among evidence considered for interim advice from JCVI to administer COVID-19 and flu vaccines at the same time, if booster programme required (July 2021)
Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial
Bristol Trials Centre work on ComFluCOV vaccine trial acknowledged
The Bristol Trial Centre was one of the recipients of the COVID-19 Collaboration in Research award at the CRN West of England research awards 2022 for their work on the ComFluCOV trial, which was delivered in just 6 months during the early part of the pandemic. Dr Rajeka Lazarus, Consultant in Infectious Diseases and Microbiology and Co-director Bristol Vaccine centre at the University of Bristol, Chief Investigator for ComFluCOV, also received the Collaborative Investigator for the Year 2022 award for her work on vaccines during the pandemic. ComFluCOV assessed if giving a COVID-19 vaccine at the same time as the influenza vaccine was safe and did not reduce the immunogenicity of either vaccine. Co-vaccination was shown to be safe and the immunogenicity of each vaccine was not compromised 1, and is the recommended vaccination programme.2-4 Professor Chris Rogers, Director of Bristol Trials Centre until July 2022 and lead for Bristol Trials Centre, said “We were delighted to work with Dr Lazarus, to deliver this landmark trial that informed international vaccination policy. It was immensely hard work and would not have been possible without the commitment of all involved, including the team at the Trials Centre, the Sponsor office (University Bristol and Weston NHS Foundation Trust), the West of England CRN, the 12 study sites and the 679 volunteers who took part”.
This work5,6 was also showcased at the International Clinical Trials Methodology Conference (ICTMC) to be held in Harrogate, 3-6 October 2022
The ComFluCOV trial is commissioned and funded by the Department of Health and Social Care (DHSC) through the National Institute for Health and Care Research (NIHR). This research was supported by the Vaccine Task Force (VTF) and NIHR Policy Research Programme (PR-R17-0916-22001, NIHR203243). This trial was designed and delivered in collaboration with the Bristol Trials Centre, a UKCRC registered clinical trials unit (CTU) which is in receipt of NIHR CTU support funding, and the NIHR-funded National Immunisation Schedule Evaluation Consortium. The views expressed are those of the author(s) and not necessarily those of the NIHR, VTF or DHSC.
1 Lazarus et al. Lancet 2021; 398,2277-87
5 Baos S et al. Delivering COVID-19 Vaccine Trials at Speed: The ComFluCOV Experience
6 Harris R and Thirard R. Working under short timescales to deliver a national trial: a case study of the ComFluCOV trial from a statistician’s perspective
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