Case study: UK leads rapid delivery of Novavax Phase 3 COVID-19 vaccine trial
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The UK’s research response to the COVID-19 pandemic was unparalleled. It triggered a system-wide, collaborative approach that enabled unprecedented speed and efficiency in clinical trial approvals, set-up and recruitment. As a result, the UK has been able to rapidly answer questions of global importance about the safety and efficacy of COVID-19 treatments and vaccines.
Novavax, a US-based biotechnology company specialising in vaccine development, benefitted from the UK’s coordinated response and was able to rapidly conduct a large-scale trial of NVX-CoV2373, it's COVID19 vaccine candidate, in record time. This study was also the largest double blind, placebo-controlled COVID-19 vaccine trial to be undertaken in the UK so far.
Wendy Talbott, Senior Director of Clinical Operations at Novavax, explains why the UK was identified as a suitable destination for a study of this size:
“We were aware that the UK had a health research system embedded in its national health service that could potentially help us enroll quickly, and this positively influenced our decision to conduct a trial in the UK. We were [also] keenly aware of the UK’s Urgent Public Health response and process. Our first port of call when bringing the trial to the UK, after the protocol was approved by MHRA, was to work with NIHR to ensure rapid recruitment and enrollment that would ideally provide a near-term view of NVX-CoV2373’s efficacy.”
The UK’s Urgent Public Health (UPH) prioritisation process was established to rapidly identify research that would help generate the clinical evidence required to combat COVID-19. This system-wide process for reviewing, approving and expediting COVID-19 research also helped to eradicate duplication of research topics across different trials, and optimise all available research resources in our NHS.
During the height of the pandemic, the UPH prioritisation panel convened via virtual meetings on a daily basis to evaluate and approve new research applications. Studies that received national UPH status were then prioritised and expedited through the research system, removing barriers and blocks to enable recruitment to commence quickly.
Once the trial was open, research teams across the NHS pulled out all the stops to meet their recruitment targets. Collectively, 33 sites across the UK enrolled 15,203 participants to the trial in just two months.
This incredible achievement was facilitated, in part, by a new online research registry that was established to enable members of the public to proactively volunteer to take part in clinical trials of COVID-19 vaccines. To date, over 452,000 volunteers have signed up (number correct on 8 March 2021) to be contacted through the NHS COVID-19 Vaccine Registry. This demonstrates that there is a huge public appetite in the UK for taking part in ground-breaking vaccine research.
Wendy Talbott recognises the role that the registry played in the UK’s rapid recruitment strategy:
“We believe the NHS’ new COVID-19 vaccine research registry had a significant impact on how quickly the trial was fully enrolled. Many of the volunteers who took part in the trial were recruited through this registry. Giving people an avenue through which they can opt in to be contacted about taking part in COVID-19 vaccine studies proved to be very effective.”
Jess from Otley is taking part in the Novavax trial, she explains why she signed up:
“When the registry went live, a friend of mine shared it on social media and I thought I really do need to put myself forward here. During the pandemic, I felt quite dis-empowered to be able to do anything to help because the most helpful thing I can do is to stay at home. But with this, it felt like I could actually do something to help the greater effort.
“I understood the registry was the route into being involved in the vaccine trials, and I felt that the way I could best contribute was to put myself forward for some form of trial because I really do think it's a collective effort to get out of this situation.”
In this video Jess explains why and how she got involved, and Immanuel describes his experience of taking part
in the Novavax trial at the national Patient Recruitment Centre in Bradford (PRC: Bradford).
Of the 33 recruiting sites, three were newly established NIHR Patient Recruitment Centres (PRCs). Like other sites, they played a key role in the rapid recruitment of volunteers to the Novavax trial. These new centres are the first family of NIHR-funded research infrastructure that is 100% dedicated to delivering commercial clinical research. They specialise in delivering large-scale, late-phase research and are ideally placed to support vaccine trials. Immanuel took part in the Novavax trial at PRC: Bradford:
“It’s been a really good experience. I’ve found it’s been very well organised, it’s just been amazing how smoothly it’s gone. There’s been a lot of flexibility around arranging appointments and when you actually get to the centre, one feels very safe there, there’s plenty of social distancing from other participants, plenty of people helping and directing where you need to go.”
For the PRCs in Blackpool, Bradford and Exeter, the Novavax trial was their debut in research delivery and, remarkably, all three sites quickly exceeded their recruitment targets. Within nine weeks PRC: Bradford recruited 726 participants against an original target of 500, PRC: Exeter recruited 545 participants against an original target of 500 and PRC: Blackpool recruited 638 participants against an original target of 300.
PRC: Blackpool was also successful in recruiting the first participant to the trial - the first person in the world to receive the Novavax vaccine in a phase 3 trial. Lakshmi Kumar, Senior Clinical Project Manager at Novavax commented on the speed of recruitment:
“The NIHR and the UK Vaccines Taskforce both played essential roles in the speedy recruitment and enrollment of volunteers. We could not have achieved our recruitment target so swiftly without the support of either organization. The second wave of high transmission in the country also accelerated the accumulation of cases. Over 15,000 participants were enrolled across 33 sites in the UK in under 10 weeks. We really appreciated the vocal support and personal participation in the study from the site leaders and staff.”
World leading research
Novavax is currently conducting additional phase 3 trials in the US and Mexico and a phase 2b trial is still underway in South Africa. But thanks to its advanced research infrastructure, integrated within the NHS, the UK was able to quickly and efficiently deliver its phase 3 trial ahead of parallel trials in other countries. Wendy Talbott commented on the UK’s performance:
“The UK was the first country to embark on and deliver a phase 3 trial for NVX CoV2373. The centralised aspect of the healthcare system in the UK facilitated record keeping, and the trial registry contributed to the efficient recruitment of participants. The trial in the UK was delivered in both an effective and skilled manner.”
On 11 March 2021, Novavax announced final efficacy results of the phase 3 trial in the UK. It revealed that the Novavax COVID-19 vaccine is around 90% effective in preventing mild, moderate and severe disease, including efficacy against new emerging variants. Importantly, there were no cases of severe disease in the vaccine arm of the trial.
The UK is a key contributor to these positive results and has shown it can quickly pivot to meet urgent research needs. Lakshmi Kumar said:
“We were very pleased with how the trial went in the UK. In Phase 3 trial results, our vaccine showed 96.4% efficacy against the original strain of SARS-CoV-2, and an 86.3% efficacy against the UK variant. These results are spectacular.”
Lessons learnt from the rapid implementation of the UPH prioritisation process are now being analysed to look at how they can inform improvements to the UK’s research capabilities in the future. Wendy Talbott is positive about her experience of delivering research in the UK:
“We are very pleased with our decision to bring the trial to the UK. It has been a pleasure working with the NIHR team and the UK Vaccines Taskforce. We are certainly open to conducting trials in the UK again.”