A world-first clinical trial looking into mixing different COVID-19 vaccine doses has been backed by £7 million of government funding
A new clinical trial, which will also be the first in the world, has launched in the UK today to look into alternating COVID-19 vaccine doses.
The study, run by the National Immunisation Schedule Evaluation Consortium (NISEC) across 8 National Institute for Health Research (NIHR) supported sites, will monitor the impact of the different dosing regimens on 800 patients’ immune responses.
Patients taking part in the 13-month study will receive different COVID-19 vaccines for their first or second dose – for example, using Oxford University/AstraZeneca’s vaccine for the first dose, followed by Pfizer/BioNTech’s vaccine for the second.
The study will initially have 8 different arms testing 8 different combinations. These include:
- 2 doses of the Oxford/AstraZeneca vaccine at 28 days apart
- 2 doses of the Oxford/AstraZeneca vaccine at 12 weeks apart – as a control group
- 2 doses of the Pfizer/BioNTech vaccine at 28 days apart
- 2 doses of the Pfizer/BioNTech vaccine at 12 weeks apart – as a control group
- the Oxford/AstraZeneca vaccine for the first dose, followed by the Pfizer/BioNTech vaccine for the second, at 28 days apart
- the Oxford/AstraZeneca vaccine for the first dose, followed by the Pfizer/BioNTech vaccine for the second, at 12 weeks apart
- the Pfizer/BioNTech vaccine for the first dose, followed by the Oxford/AstraZeneca vaccine for the second, at 28 days apart
- the Pfizer/BioNTech vaccine for the first dose, followed by the Oxford/AstraZeneca vaccine for the second, at 12 weeks apart
The Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency (MHRA) have given their approval for the study to go ahead.
Minister for COVID-19 Vaccine Deployment, Nadhim Zahawi, said:
“This is a hugely important clinical trial that will provide us with more vital evidence on the safety of these vaccines when used in different ways.
“Nothing will be approved for use more widely than the study, or as part of our vaccine deployment programme, until researchers and the regulator are absolutely confident the approach is safe and effective.
“This is another great step forwards for British science, expertise and innovation, backed by government funding – and I look forward to seeing what it produces.”
Deputy Chief Medical Officer and Senior Responsible Officer for the study, Professor Jonathan Van-Tam, said:
“Given the inevitable challenges of immunising large numbers of the population against COVID-19 and potential global supply constraints, there are definite advantages to having data that could support a more flexible immunisation programme, if needed and if approved by the medicines regulator.
“It is also even possible that by combining vaccines, the immune response could be enhanced giving even higher antibody levels that last longer; unless this is evaluated in a clinical trial we just won’t know.
“This study will give us greater insight into how we can use vaccines to stay on top of this nasty disease.”
Chief Investigator Matthew Snape, Associate Professor in Paediatrics and Vaccinology at the University of Oxford, said:
“This is a tremendously exciting study that will provide information vital to the roll out of vaccines in the UK and globally. We call on those aged 50 years and above who have not yet received a COVID-19 vaccine to visit our website to find out more about the study and see if there is a study site near them.
“If we do show that these vaccines can be used interchangeably in the same schedule this will greatly increase the flexibility of vaccine delivery, and could provide clues as to how to increase the breadth of protection against new virus strains.”
National Clinical Lead for the NIHR COVID Vaccine Research Programme, Professor Andrew Ustianowski, said:
“This is another exciting step forward in finding a variety of vaccine options for the UK and globally, for which the NIHR is integral to ensuring the participant recruitment for this study and the gaining of robust data on safety and effectiveness.
“We need people from all backgrounds to take part in this trial so that we can ensure we have vaccine options suitable for all. Signing up to volunteer for vaccine studies is quick and easy via the NHS Vaccine Research Registry.”
Interim Chair of the government’s Vaccines Taskforce, Clive Dix, said:
“Thanks to funding from the Vaccines Taskforce, this study will give us valuable insight into how vaccines work together and could give us more flexibility as we continue to tackle this virus in the weeks, months and years ahead.
“This is yet another example of the UK leading the way in vital research into COVID-19 – and something that people both in this country and around the world, could benefit from.”