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World’s first participants for Novavax phase 3 Covid-19 vaccine trial enroll through NIHR Patient Recruitment Centre

 

The world’s first participants to take part in a phase 3 trial of the Novavax Covid-19 vaccine candidate were recently recruited at a new NIHR National Patient Recruitment Centre (NPRC) based in Blackpool.

US-based biotechnology firm, Novavax, launched the phase 3 clinical trial of a potential Covid-19 vaccine, NVX-CoV2373, in the UK on 23 September 2020. The first participants enrolled at the new NIHR research centre in Blackpool just five days later, on 28 September.

Brought to the UK in collaboration with the UK Government’s Vaccines Taskforce, the Novavax trial is investigating the safety, efficacy and immunogenicity of NVX-CoV2373. It will recruit up to 10,000 participants aged 18 to 84 years, with and without relevant comorbidities, over the next few weeks.

A parallel phase 3 study is due to commence in the USA during quarter 4, 2020. However, with the advanced research infrastructure already in place within the UK - including the NIHR’s National Patient Recruitment Centres and the NHS Vaccine Research registry - the UK study was able to get underway sooner.

The new NIHR National Patient Recruitment Centre in Blackpool is one of five opening this autumn across England. The centre is hosted by Blackpool Teaching Hospital NHS Foundation Trust and funded by the National Institute for Health Research (NIHR).

The five regionally based centres are dedicated to setting up and delivering large, late-phase commercial clinical trials across the NHS. They are purpose-designed to improve the speed and consistency with which commercial research is delivered across the country. A key feature of their operating model is to collaborate across the local and regional health sector to enable access to a wider cohort of patients. The centres will play a key role in helping people across England to take part in vital Covid-19 vaccine trials over the coming months.

Currently, participant recruitment and delivery of the Novavax vaccine trial is being supported by NIHR National Patient Recruitment Centres in Blackpool (covering the North West region); Bradford (covering Yorkshire and Humberside); and Exeter (covering the South West region).

Gregory M. Glenn, M.D., President of Research & Development from Novavax said:

“When the UK Government approached us earlier this year about our work and conducting a phase 3 trial, we were quite interested. The NIHR trial network is excellent in terms of both the infrastructure and the investigators themselves. In addition, the clear communication with MHRA laid out expectations with respect to trial requirements. At this point, early enrolment success in the sites at Blackpool, Bradford, Exeter and other sites is very encouraging and while the COVID-19 resurgence is unfortunate, it should help us answer the fundamental questions around efficacy in a very rapid manner.”

Layton Medical Centre, a primary care general practice, collaborated with the newly established NPRC Blackpool to successfully recruit the first participants into this important global Covid-19 vaccine trial.

Dr Rebecca Clark, a GP at the practice and Principal Investigator on the vaccine study, commented:

“The UK’s National Patient Recruitment Centres are playing a key role in the global fight against this pandemic. Drawing upon the country’s renowned research expertise and the world’s largest, and most fully integrated healthcare system, the PRCs are providing a unique proposition to the life science industry. Leading biotech and pharmaceutical companies are bringing phase 3 trials to the PRCs so that COVID-19 vaccine research can be delivered at pace and scale in a safe environment. We look forward to continued collaboration with leading life science companies.”

The Novavax trial is also now open for recruitment at the Bradford National Patient Recruitment Centre (NPRC) - with 194 participants enrolled since it opened in early October and 500 expected to join the study through the Yorkshire-based NPRC by the end of the month.

Professor Dinesh Saralaya is Consultant Respiratory Physician at Bradford Teaching Hospitals NHS Foundation Trust and Director of the NPRC, said:

“To ensure that Covid-19 vaccines work for everyone - it is critically important that we are able to ensure participants are represented from all areas of society - including from all black and minority ethnic (BAME) groups. Bradford NPRC serves a region with a large BAME community – so it is well placed to help people from these communities take part in and benefit from this most vital research.

“We hope that research such as the Novavax vaccine study, which is now being delivered across the country through the NIHR’s National Patient Recruitment Centres alongside our NHS partners - will one day soon lead to a major breakthrough in the fight against Covid-19 and ultimately save many lives.”

Volunteer Gill Brook from Yorkshire was one of the first participants to take part in the Novavax study at the Bradford NPRC. She said:

“I’ve just had my jab as part of the coronavirus vaccine trial. I felt it was important to volunteer. I think a lot of us feel that there’s not a lot that we can do, but this is something positive that we can do that will hopefully help find an effective vaccine that will benefit us all. So I’d encourage anyone eligible to apply to be part of this trial.”

The Novavax trial is also being run from the National Patient Recruitment Centre based in Exeter, with the first participant enrolling at the centre on Monday 12 October, and 54 participants recruited to the study through the NPRC during the first week. 

One of the first participants to receive the vaccine at the South West-based NPRC, Christopher from Exeter said:

“I am delighted to be part of the Novavax phase 3 trial. As an engineer, I know the importance of science in overcoming society’s greatest challenges. Participation in the trial means a lot to me. I am finally able to contribute meaningfully in our fight against Covid, which has threatened our lives and our way of life.”

About the Novavax Covid-19 vaccine trial

The Novavax phase 3 trial will focus on the vaccine’s effectiveness, with further checks on safety in a larger population. This follows earlier, smaller studies (phase 1 and 2 in Australia and phase 2b in South Africa). The phase 1 study reported positive results at the beginning of August which showed that the vaccine was generally well-tolerated and was able to trigger significant antibody responses.

The phase 3 trial is a randomised, placebo-controlled, observer-blinded trial during which 50% of volunteers will be given two intramuscular injections of the vaccine candidate, 21 days apart, while the remaining will receive placebo.

The Novavax trial is the second phase 3 trial to commence in the UK, following AstraZeneca phase 3 trials at University of Oxford. Participants for the phase 3 trial will be drawn from the NHS Covid-19 Vaccine Research Registry: www.nhs.uk/researchcontact

The registry was launched in July to help create a database of people who consent to be contacted by the NHS to take part in clinical studies with the aim to help speed up the development of a safe and effective vaccine against coronavirus. It has been developed as part of the UK Government’s Vaccine Taskforce, in partnership with the National Institute for Health Research (NIHR), NHS Digital, and the Northern Ireland, Scottish and Welsh Governments.