COVID-19 Vaccine Clinical Trial

A new clinical trial to assess the efficacy and safety of a novel COVID-19 vaccine

The purpose of this clinical trial is to test a new vaccine against COVID-19 and we are looking for volunteers to take part.

  • If you are aged 18-84 and in good health, you could be eligible to participate 
  • The study involves a minimum of 6 visits over a period of around 13 months 
  • This study is being conducted across multiple locations in the UK (see below)

Background

A new virus causing respiratory disease emerged in Wuhan, China in December 2019 and has since rapidly spread to many other countries around the world, despite containment efforts. 

The virus is part of the Coronavirus family, which may cause respiratory infections ranging from the common cold to more severe diseases. This recently discovered coronavirus (called SARS-CoV-2) causes a disease called COVID-19. 

There are no currently licensed vaccines for COVID-19. Vaccines are the most cost effective way of controlling outbreaks and the international community has stepped-up their efforts towards developing one against COVID-19.

Aims of the study

This new clinical trial will enable us to assess if people aged 18-84 years can be protected from COVID-19 with this investigational vaccine called (SARS-CoV 2 Recombinant(r) Spike (S) Protein Nanoparticle Vaccine (SARSCoV2 rS) with Matrix-M adjuvant). 

It will also give valuable information on the safety aspects of the vaccine.  

Key dates

The recruitment start and end dates are as follows:

Start: Wednesday 23 September 2020

End:  Friday 21 January 2022

What does taking part involve?

During this study, we will recruit up to 9000 volunteers who will be randomly assigned to one of two groups.  

One group will be vaccinated with the COVID-19 investigational vaccine and the other group will be vaccinated with a saline placebo. Saline is a mixture of salt and water. A placebo is a substance that has no therapeutic or medicinal effect and is used regularly in testing new drugs.  Volunteers will not know which group they are in.

Participants will receive 2 doses, around 21 days apart. In addition they will have blood tests and nasal/throat swabs. They will have information collected about any COVID-19 related symptoms that occur during the trial.

Everyone taking part, no matter which group they are assigned to, will need to attend at least 6 visits to the local study site over a period of around 13 months.

Please refer to the information sheet for full details of procedures and potential risks. (this will link)

Who can take part?

Participants who are likely to have had higher exposure to COVID-19 will be prioritised.  This is to help increase the likelihood of seeing an  impact from the treatment. 

In order to be considered to take part, you must: 

  • Be aged between 18 and 84 years (inclusive) 
  • Be in good health

You must NOT:

  • Have tested positive for COVID-19
  • Be pregnant, intending to become pregnant, or breastfeeding during the trial
  • Have previously taken part in a trial with a coronavirus vaccine

Where can I take part?

If you are unsure of which region you should contact, please find a list of local hospitals under each section below.  This list is only to help you identify with the right region.  Your nearest hospital might not necessarily be taking part in this study. 

Carmel Medical Practice, Nunnery Lane, Darlington, County Durham, DH3 8SQ

Awaiting contact details

List of hospitals covered by this study:

  • County Durham and Darlington NHS Foundation Trust
  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
  • Gateshead Health NHS Foundation Trust
  • Newcastle Upon Tyne Hospitals NHS Foundation Trust
  • North Cumbria Integrated Care NHS Foundation Trust
  • North East Ambulance Service NHS Foundation Trust
  • North Tees and Hartlepool NHS Foundation Trust
  • Northumbria Healthcare NHS Foundation Trust
  • South Tees Hospitals NHS Foundation Trust
  • South Tyneside and Sunderland NHS Foundation Trust
  • Tees, Esk and Wear Valleys NHS Foundation Trust

Bradford Teaching Hospitals NHS Foundation Trust

Awaiting contact details

Contact this study team if your local hospital is:

  • Airedale NHS Foundation Trust
  • Barnsley NHS Foundation Trust
  • Bradford District Care NHS Foundation Trust
  • Bradford Teaching Hospitals NHS Foundation Trust
  • Calderdale and Huddersfield NHS Foundation Trust
  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  • Harrogate and District NHS Foundation Trust
  • Hull University Teaching Hospitals NHS Trust
  • Humber Teaching NHS Foundation Trust
  • Leeds and York Partnership NHS Foundation Trust
  • Leeds Community Healthcare NHS Trust
  • Leeds Teaching Hospitals NHS Trust
  • Mid Yorkshire Hospitals NHS Trust
  • North Lincolnshire and Goole NHS Foundation Trust
  • Rotherham Doncaster and South Humber NHS Foundation Trust
  • Sheffield Children's NHS Foundation Trust
  • Sheffield Health and Social Care NHS Foundation Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust 
  • South West Yorkshire Partnership NHS Foundation Trust
  • The Rotherham NHS Foundation Trust 
  • York Teaching Hospitals NHS Foundation Trust
  • Yorkshire Ambulance Service NHS Trust

North Manchester General Hospital (Northern Care Alliance)

Awaiting contact details

Contact this study team if your local hospital is:

  • Manchester University NHS Foundation Trust 
  • Salford Royal NHS Foundation Trust 
  • Pennine Acute Hospitals NHS Trust 
  • Stockport NHS Foundation Trust 
  • The Christie NHS Foundation Trust 
  • Wrightington, Wigan and Leigh NHS Foundation Trust  
  • Bolton NHS Foundation Trust 
  • Pennine Care NHS Foundation Trust  
  • Greater Manchester Mental Health NHS Foundation Trust  
  • Bridgewater Community Healthcare NHS Foundation Trust  
  • Tameside and Glossop Integrated Care NHS Foundation Trust 
  • North West Ambulance Service NHS Trust  
  • East Lancashire Hospitals NHS Trust
  • East Cheshire NHS Trust 

Blackpool Teaching Hospitals NHS Foundation Trust & Layton Medical Centre, Blackpool

Awaiting contact details

Contact this study team if your local hospital is:

  • Alder Hey Children’s NHS Foundation Trust
  • Blackpool Teaching Hospitals NHS Foundation Trust
  • Cheshire and Wirral Partnership NHS Foundation Trust
  • Countess of Chester Hospital NHS Foundation Trust
  • Lancashire Care NHS Foundation Trust
  • Lancashire Teaching Hospitals NHS Foundation Trust
  • Liverpool Heart & Chest Hospital NHS Foundation Trust
  • Liverpool Womens Hospital NHS Foundation Trust
  • Mid Cheshire Hospitals NHS Foundation Trust
  • Mersey Care NHS Foundation Trust
  • North West Boroughs Healthcare Foundation Trust
  • Liverpool University Hospital Foundation Trust
  • Southport and Ormskirk Hospital NHS Foundation Trust
  • St Helens and Knowsley Hospitals NHS Foundation Trust
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • University Hospitals of Morecambe Bay NHS Foundation Trust
  • Walton Centre NHS Foundation Trust
  • Warrington & Halton NHS Foundation Trust
  • Wirral University Teaching Hospital NHS Foundation Trust
  • Wirral Community NHS Foundation Trust

Lakeside Surgery, UCC Building, Cottingham Road, Corby, NN17 2UR

Awaiting contact details

Contact this study team if your local hospital is:

  • Chesterfield Royal Hospital NHS Foundation Trust
  • Derbyshire Community Health Services NHS Foundation Trust
  • Derbyshire Healthcare NHS Foundation Trust
  • East Midlands Ambulance Service NHS Trust
  • Kettering General Hospital NHS Foundation Trust
  • Leicestershire Partnership NHS Trust
  • Lincolnshire Community Health Services NHS Trust
  • Lincolnshire Partnership NHS Foundation Trust
  • Northampton General Hospital NHS Trust
  • Northamptonshire Healthcare NHS Foundation Trust
  • Nottingham University Hospitals NHS Trust
  • Nottinghamshire Healthcare NHS Foundation Trust
  • Sherwood Forest Hospitals NHS Foundation Trust
  • United Lincolnshire Hospitals NHS Trust
  • University Hospitals of Derby and Burton NHS Foundation Trust
  • University Hospitals of Leicester NHS Trust

Midlands Foundation NHS Trust

Dr John Packham & Dr Chris Green

Awaiting contact details

Contact this study team if you live in:

  • Shropshire
  • Staffordshire
  • County of the West Midlands
  • Warwickshire
  • Worcestershire
  • Herefordshire

Oxford Health NHS Foundation Trust
Dr Angela Minassian

Awaiting contact details

Contact this study team if your local hospital is:

Berkshire
  • Berkshire Healthcare NHS Foundation Trust
  • Royal Berkshire NHS Foundation Trust
  • East Berkshire Clinical Commissioning Group
  • Berkshire West Clinical Commissioning Group
Buckinghamshire
  • Buckinghamshire Clinical Commissioning Group
  • Buckinghamshire Healthcare NHS Trust
  • Milton Keynes Clinical Commissioning Group
  • Milton Keynes University Hospital NHS Foundation Trust
Oxfordshire
  • Oxford Health NHS Foundation Trust
  • Oxford University Hospitals NHS Foundation Trust
  • Oxfordshire Clinical Commissioning Group

Norfolk and Norwich University Hospital NHS Foundation Trust

Awaiting contact details

Contact this study team if your local hospital is:

  • Bedfordshire Hospitals NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • Cambridgeshire and Peterborough NHS Foundation Trust
  • Cambridgeshire Community Services NHS Trust
  • East and North Hertfordshire NHS Trust
  • East of England Ambulance Service NHS Trust
  • East Suffolk and North Essex NHS Foundation Trust
  • Hertfordshire Partnership NHS Foundation Trust
  • James Paget University NHS Foundation Trust
  • Norfolk Community Health and Care NHS Trust
  • Norfolk and Norwich University Hospitals NHS Foundation Trust (Host)
  • Norfolk and Suffolk NHS Foundation Trust
  • North West Anglia NHS Foundation Trust
  • Papworth Hospital NHS Foundation Trust
  • Queen Elizabeth Hospital, King's Lynn, NHS Foundation Trust
  • West Suffolk Hospital NHS Foundation Trust

Dr Fiona Burns

Awaiting contact details

Contact this study team if your local hospital is:

  • Barking, Havering and Redbridge University Hospitals NHS Trust
  • Barnet, Enfield and Haringey Mental Health NHS Trust
  • Barts Health NHS Trust
  • Basildon and Thurrock University Hospitals NHS Foundation Trust
  • Camden and Islington NHS Foundation Trust
  • East London NHS Foundation Trust
  • Essex Partnership NHS Foundation Trust
  • Great Ormond Street Hospital for Children NHS Foundation Trust
  • Hertfordshire Community NHS Trust
  • Homerton University Hospital NHS Foundation Trust
  • Mid Essex Hospital Services NHS Trust
  • Moorfields Eye Hospital NHS Foundation Trust
  • North East London NHS Foundation Trust
  • North Middlesex University Hospital NHS Trust
  • Royal Free London NHS Foundation Trust
  • Royal National Orthopaedic Hospital NHS Trust
  • Southend University Hospital NHS Foundation Trust
  • Tavistock and Portman NHS Foundation Trust
  • The Princess Alexandra Hospital NHS Trust
  • The Whittington Hospital NHS Trust
  • University College London Hospitals NHS Foundation Trust
  • West Hertfordshire Hospitals NHS Trust

Dr. Marta Boffito


Chelsea and Westminster Hospital NHS Foundation Trust, London

Awaiting contact details

Contact this study team if your local hospital is:

  • Central and North West London NHS Foundation Trust
  • Central London Community Healthcare NHS Trust
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • Imperial College Healthcare NHS Trust
  • London Ambulance Service NHS Trust
  • London North West University Healthcare NHS Trust
  • Royal Brompton and Harefield NHS Trust
  • The Hillingdon Hospital NHS Trust
  • West London NHS Trust

Dr Catherine Cosgrove or CI Prof Paul Heath

Awaiting contact details

Contact this study team if your local hospital is:

Dr Rajeka Lazarus
University Hospitals Bristol and Weston NHS Foundation Trust

Awaiting contact details

  • University Hospitals Bristol and Weston NHS Foundation Trust
  • North Bristol NHS Trust
  • Royal United Hospitals Bath NHS Foundation Trust
  • Gloucestershire Hospitals NHS Foundation Trust
  • Avon and Wiltshire Mental Health Partnership NHS Trust
  • Gloucestershire Health and Care NHS Foundation Trust
  • Great Western Hospitals NHS Foundation Trust, Swindon

University Hospital Southampton NHS Foundation Trust
Dr Patrick Moore

Awaiting contact details

Contact this study team if your local hospital is:

Dorset

  • Dorset County Hospital NHS Foundation Trust
  • Dorset Healthcare University NHS Foundation Trust
  • Poole Hospital NHS Foundation Trust
  • The Royal Bournemouth and Christchurch NHS Foundation Trust 

Hampshire

  • Hampshire Hospitals NHS Foundation Trust
  • Portsmouth Hospitals University NHS Trust
  • Solent NHS Trust  
  • South Central Ambulance Service NHS Foundation Trust
  • Southern Health NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust

Isle of Wight NHS Trust

Salisbury NHS Foundation Trust

The Royal Devon & Exeter NHS Foundation Trust (Host Organisation) on behalf of the South West Peninsula
Dr Thomas Burden

Awaiting contact details

Contact this study team if your local hospital is:

  • Cornwall Partnership NHS Foundation Trust
  • Devon Partnership NHS Trust
  • Livewell Southwest
  • Northern Devon Healthcare NHS trust
  • Royal Cornwall Hospitals NHS Trust
  • Royal Devon & Exeter NHS Foundation Trust
  • Somerset NHS Foundation Trust
  • South Western Ambulance Service NHS Foundation Trust
  • Torbay & South Devon NHS Foundation Trust
  • University Hospitals Plymouth NHS Trust
  • Yeovil District Hospital NHS Foundation Trust

Questions about taking part in vaccine studies

Read a list of frequently asked questions from members of the public about taking part in vaccine studies.

Questions about this study

What will happen if I don’t want to carry on with the study?

Participation is voluntary and you are free to change your mind and withdraw at any time. You do not need to provide a reason.  This will not affect your subsequent medical care in any way. If you withdraw from taking part, we might need to offer you a follow up visit, for example to check the vaccination site or a blood result.

What are the advantages of taking part?

Knowledge gained from this study will help us develop a vaccine against the newly emerged coronavirus disease COVID-19. Participation could really make a difference during a public health emergency.

Are there any risks from taking part?

Although this is a new vaccine, similar investigational vaccines have been widely administered for other conditions without significant safety concerns. The risks and side effects of the proposed study procedures are:

  • Blood samples: drawing blood may cause slight pain and occasionally bruising
  • Vaccinations:  Common side effects are some mild redness and swelling at the injection site. You may feel like you have flu-like symptoms within 24 hours of the vaccinations.  

These usually resolve within 48 hours.