Leeds Teaching Hospitals Highest Recruiter to Novavax COVID-19 Vaccine Trial

Tuesday 16th March 2021

When the NHS COVID-19 Vaccine Research Registry was launched Leeds was the highest recruiter within the Yorkshire and Humber region and quickly gained thousands of volunteers. The NIHR-supported Novavax COVID-19 vaccine study is the largest ever double-blind, placebo-controlled trail to be undertaken in the UK. with over 15,000 participants across 35 sites. The interim efficacy data released at the end of January showed 89.3% effectiveness at preventing COVID-19 and Leeds was the number one recruiter with 806 participants from the Leeds area taking part.

During the planning stages the Novavax Vaccine Team - involving staff from the Leeds CRF, Covid Research team and the Research & Innovation Department - wanted to offer the study to as many participants as possible and opted for a large scale operation which took place at The Edge Sports Hall courtesy of the University of Leeds. This translated into 806 participants attending twice between October and late December. Half were given the vaccine and the other half were given placebo. This was a massive undertaking as the initial visit involved vital signs such as blood pressure and pulse, medical examination, blood and swab tests and monitoring post vaccine/placebo, so the first visit could take over 2 hours.

Picture1

Picture2

 

 

 

 

 

The multidisciplinary team from Leeds Teaching Hospital NHS Trust: medics, nurses, clinical trials assistants, administration, transport, pharmacy, logistics worked alongside the University catering, sports, security, electricians, and printing staff in true Leeds Way style.

The Leeds CRF involved Patient and Public Involvement and Engagement  (PPIE) right from the outset with PPIE representatives being part of the various organising sub-groups such as location, logistics, participants and communications.

Participants in this trial attend for 3-month, 6-month and 12-month follow-up visits and due to the University of Leeds re-opening to their student population the Thackray Medical Museum kindly stepped in.  The Thackray is already hosting the Pfizer vaccination work including the vaccination of frontline NHS staff, but was also able to offer some community space to the Novavax vaccine team from January to March to complete the 3 month follow-up visits and data.