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Clinical Trial
. 2024 Jan 11;25(1):39.
doi: 10.1186/s13063-023-07862-4.

Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV)

Sarah Baos  1 , Rachel Todd  2 , Russell Thirard  1 , Rosie Harris  1 , Jana Kirwan  1 , Katherine Joyce  1 , David Hutton  1 , Adam Finn  3 , Madeleine Clout  1 , Heike Cappel-Porter  1 , Chris A Rogers  1 , Rajeka Lazarus  4 , Lucy Culliford  1
Affiliations
Clinical Trial

Delivering COVID-19 vaccine trials at speed: the implementation of a phase IV UK multi-centre randomised controlled trial to determine safety and immunogenicity of COVID-19 vaccines co-administered with seasonal influenza vaccines (ComFluCOV)

Sarah Baos et al. Trials. .

Abstract

Background: In February 2021, the UK Department of Health and Social Care sought evidence on the safety and immunogenicity of COVID-19 and influenza vaccine co-administration to inform the 2021/2022 influenza vaccine policy. Co-administration could support vaccine uptake and reduce healthcare appointments. ComFluCOV was a randomised controlled trial designed to provide this evidence. This report outlines the methods used to deliver the trial in 6 months to answer an urgent public health question as part of the COVID-19 pandemic response.

Methods: ComFluCOV was commissioned by the Department of Health and Social Care and was managed by the Bristol Trials Centre, a UK-registered clinical trials unit. It was classed as an Urgent Public Health trial which facilitated fast-track regulatory approvals. Trial materials and databases were developed using in-house templates and those used in other COVID-19 vaccine trials. Participants were recruited by advertising, and via a trial website. Electronic trial systems enabled daily review of participant data. Weekly virtual meetings were held with stakeholders and trial sites.

Results: ComFluCOV was delivered within 6 months from inception to reporting, and trial milestones to inform the Department of Health and Social Care policy were met. Set-up was achieved within 1 month. Regulators provided expedited reviews, with feedback ahead of submission. Recruitment took place at 12 sites. Over 380 site staff were trained. Overall, 679 participants were recruited in two months. The final report to the Department of Health and Social Care was submitted in September 2021, following a preliminary safety report in May 2021. Trial results have been published.

Conclusion: The rapid delivery of ComFluCOV was resource intensive. It was made possible in part due to a unique set of circumstances created by the pandemic situation including measures put in place to support urgent public health research and public support for COVID-19 vaccine research. Elements of the trial could be adopted to increase efficiency in 'non-pandemic' situations including working with a clinical trials unit to enable immediate mobilisation of a team of experienced researchers, greater sharing of resources between clinical trials units, use of electronic trial systems and virtual meetings.

Trial registration: ISRCTN14391248, submitted on 17/03/2021. Registered on 30/03/2021.

Keywords: COVID-19 vaccine; Efficient delivery; Influenza vaccine; Randomised controlled trial (RCT); Urgent Public Health (UPH).

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Conflict of interest statement

RL reports being the Principle and Chief Investigator for studies sponsored by commercial organisations including Moderna, Janssen, Astra-Zeneca, and Valneva. Consultation fees received for professional services funded by Sanofi and Astra-Zeneca. SB, LC and CAR reports grants from NIHR, during the conduct of the trial. AF reports grants from Pfizer during the conduct of the trial, and grants from Elizabeth Blackwell Institute, Sanofi Pasteur, VBI Vaccines, Pfizer, Janssen, GSK, MedImmune, Novavax, and Valneva outside the submitted work. All other authors, RTo, RTh, RH, JK, KJ, DH, MC and HCP, declare no competing interests.

Figures

Fig. 1
Fig. 1
Trial schema outlining trial design
Fig. 2
Fig. 2
Gantt chart outlining the delivery timelines for the ComFluCOV study
Fig. 3
Fig. 3
Participant recruitment over time
See this image and copyright information in PMC

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