The booster will be going through a phase 3 trial, which will involve 3000 participants across 29 centres
Moderna, in collaboration with the National Institute for Health Research (NIHR), is set to launch a phase 3 trial in the UK for an Omicron-specific COVID-19 variant vaccine (mRNA-1273.529) as a first or second booster.
The first commercially sponsored Moderna vaccine trial in the UK will involve 3000 participants across 29 centres in England, Scotland, and Wales, all of whom are eligible for a first or second booster. The study is being led by a team based at St George’s, University of London, and will commence recruitment in the next 3 weeks.
Professor Lucy Chappell, Chief Executive of the NIHR, said: ‘The last 2 years have demonstrated the vital importance of international scientific collaboration. So it is truly exciting to see the NIHR and Moderna working with research teams across the UK on Moderna’s first major UK COVID-19 vaccine study.’
The eligibility criteria for the trial is for participants to haven taken their last vaccine dose at least 3 months before enrolment in the trial, and not to have had a confirmed severe acute respiratory syndrome coronavirus-2 infection since the beginning of November 2021. Participants aged 16 years and older will be randomly assigned (1:1) to receive either Moderna’s Omicron-specific variant vaccine or the standard Moderna COVID-19 vaccine (mRNA-1273; Spikevax).
Booster data and parallel trials
Last month, Moderna highlighted findings from a study of neutralising antibody levels against Omicron 6 months after a booster dose. The antibody levels against Omicron declined 6 months after the third 50-mcg dose of Spikevax, but were still detectable.
Moderna also announced the launch of a phase 2 trial investigating the safety, reactogenicity, and immunogenicity of the Omicron-specific booster candidate as a single dose. The trial involves around 300 participants across 14 centres in the US.
Moderna’s Omicron-specific vaccine candidate will also be pitted against the standard Pfizer/BioNTech COVID-19 vaccine in the COV-Boost substudy, both used as the second booster.
Role of the UK praised
Health and Social Care Secretary Sajid Javid commented: ‘The UK is a world leader when it comes to the research and development of vaccines and medicines, bolstered by our renowned life sciences industry. It’s fantastic to see these capabilities being put to good use, with almost 3000 people expected to take part in this important clinical trial. I want this country to be the best place in the world to launch clinical trials.’
Dr Catherine Cosgrove, the trial’s Chief Investigator, added: ‘I am very excited to be leading this new study which looks into Moderna’s Omicron variant vaccine and the impact of a fourth dose. We are all so proud of the thousands of study volunteers in the UK who have come forward to help during this pandemic and without whom vaccine development would not have been possible.’
This article was originally published on Medscape, part of the Medscape Professional Network.
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