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COVID-19 vaccine to begin phase II/III human trials in Nottingham

Tuesday, 26 May 2020

The University of Nottingham Health Service, at Cripps Medical Centre, University Park, is recruiting for the next phase in human trials of a COVID-19 vaccine in human volunteers.

The vaccine has been developed by researchers from the University of Oxford.

The phase I trial in healthy adult volunteers began in April. More than 1,000 immunisations have been completed and follow-up is currently ongoing.

The next study will enrol up to 10,260 adults and children and will involve a number of partner institutions across the country, including the University of Nottingham Health Service.

High exposure workers, particularly frontline health care workers, in the East Midlands region aged 18-55 years are initially being invited to take part in the study, followed by volunteers aged 56-69 years and 70 years and over. Following expressions of interest and completion of an eligibility questionnaire, screening visits will commence on Tuesday 26th May. 

Volunteers will attend the Cripps Medical Centre on University Park in Nottingham to take part in the trial. People interested in taking part can visit the website for more information and to register: https://www.covid19vaccinetrial.co.uk/participate-trial.

The study is one of 41 urgent COVID-19 studies supported by the National Institute for Health Research (NIHR) as part of the national response to the disease. Research activity at Cripps Medical Centre will be overseen by Dr David Turner and Dr Simon Royal, supported by research delivery teams from the NIHR Clinical Research Network (CRN) East Midlands.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of older adults and children:

  • Aged 56-69
  • Aged over 70
  • Aged between 5-12 years

For these groups, researchers will be assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children.

The phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18. This group will assess how well the vaccine works to prevent people from becoming infected and unwell with COVID-19.

Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison.

ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to replicate in humans.

This next phase is of huge importance: this trial will test whether the Covid-19 vaccine can provide protection in the wider population. It is incredibly important that we recruit people for this important study and we are very grateful for the support of the trial volunteers in helping test whether this new vaccine could protect humans against the pandemic coronavirus. The trial will also evaluate how well the vaccine induces immune responses and protection in older adults”.
Dr David Turner, Honorary Consultant in Clinical Microbiology at Nottingham University Hospitals NHS Trust and Associate Professor at the University of Nottingham, and lead researcher for the trial in Nottingham

Sarah Gilbert, Professor of Vaccinology at the Jenner Institute, said: “The COVID-19 vaccine trial team have been working hard on assessing the safety and immunogenicity of ChAdOx1 nCoV-19, and preparing to assess vaccine efficacy. We have had a lot of interest already from people over the age of 55 years who were not eligible to take part in the phase I study, and we will now be able to include older age groups to continue the vaccine assessment. We will also be including more study sites, in different parts of the country.”

This study aims to assess how well people across a broad range of ages could be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

Story credits

More information is available from Dr David Turner from the School of Medicine at the University of Nottingham, at david.turner@nottingham.ac.uk

 

Notes to editors:

 

The Oxford Vaccine Centre COVID-19 Phase II/III Clinical Trial Explained

What is the purpose of this research study?

The purpose of this study is to test a new vaccine against COVID-19 in healthy volunteers.

This study aims to assess how well people across a broad range of ages could be protected from COVID-19 with this new vaccine called ChAdOx1 nCoV-19. It will also provide valuable information on safety aspects of the vaccine and its ability to generate good immune responses against the virus.

What is the vaccine being tested?

ChAdOx1 nCoV-19 is made from a virus (ChAdOx1), which is a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees, that has been genetically changed so that it is impossible for it to grow in humans.

Genetic material has been added to the ChAdOx1 construct that is used to make proteins from the COVID-19 virus (SARS-CoV-2) called Spike glycoprotein (S). This protein is usually found on the surface of SARS-CoV-2 and plays an essential role in the infection pathway of the SARS-CoV-2 virus. The SARS-CoV-2 coronavirus uses its spike protein to bind to ACE2 receptors on human cells to gain entry to the cells and cause an infection.

By vaccinating with ChAdOx1 nCoV-19, we are hoping to make the body recognise and develop an immune response to the Spike protein that will help stop the SARS-CoV-2 virus from entering human cells and therefore prevent infection.

Has the vaccine been tested on animals?

Our collaborators at Rocky Mountain Laboratories (NIAID/NIH) have conducted a rapid yet thorough investigation and demonstrated good safety and efficacy of a single dose of ChAdOx1 nCoV-19 in the rhesus macaque model that they had previously established. We were able to review the data before vaccinations in the clinical trial were initiated. There are also animal studies underway in Australia and the UK, and the results will be published once those studies are complete.

What does the study involve?

In total this study will enrol up to 10,260 adults and children across the UK.

The phase II part of the study involves expanding the age range of people the vaccine is assessed in, to include a small number of adults and children:

  • Aged 56-69
  • Aged over 70
  • Aged between 5-12 years

For these groups, researchers are assessing the immune response to the vaccine in people of different ages, to find out if there is variation in how well the immune system responds in older people or children.

The phase III part of the study involves assessing how the vaccine works in a large number of people over the age of 18. This group will allow assessment of how well the vaccine works to prevent people from becoming infected with COVID-19.

Adult participants in both the Phase II and Phase III groups will be randomised to receive one or two doses of either the ChAdOx1 nCoV-19 vaccine or a licensed vaccine (MenACWY) that will be used as a ‘control’ for comparison.

What is the MenACWY vaccine?

The MenACWY vaccine is a licensed vaccine against group A, C, W and Y meningococcus which has been given routinely to teenagers in the UK since 2015 and protects against one of the most common causes of meningitis and sepsis. This vaccine is also given as a travel vaccine for high risk countries.

The MenACWY vaccine is being used as an ‘active control’ vaccine in this study, to help us understand participants’ response to ChAdOx1 nCoV-19. The reason for using this vaccine, rather than a saline control, is because we expect to see some minor side effects from the ChAdOx1 nCOV-19 vaccine such as a sore arm, headache and fever. Saline does not cause any of these side effects. If participants were to receive only this vaccine or a saline control, and went on to develop side effects, they would be aware that they had received the new vaccine. It is critical for this study that participants remain blinded to whether or not they have received the vaccine, as, if they knew, this could affect their health behaviour in the community following vaccination, and may lead to a bias in the results of the study.

Who can take part in the study?

Participants must:

Participants must NOT:

Be in one of the relevant age categories

Have tested positive for COVID-19

Be in good health

Be pregnant, intending to become pregnant, or breastfeeding during the study

Based in one of the recruiting areas

Have previously taken part in a trial with an adenoviral vaccine or received any other coronavirus vaccines

 

Full inclusion and exclusion criteria are available in the participant information sheet.

 How will the trial work?

The main focus of the study is to find out if this vaccine is going to work against COVID-19, if it won’t cause unacceptable side effects and if it induces good immune responses. The dose used in this trial was chosen based on previous experiences with other ChAdOx1 based vaccines.

Study participants will not know whether they have received the ChAdOx1 nCoV-19 vaccine until the end of the trial.

To recruit the large number of participants needed for this trial, multiple clinical research sites across the UK are involved in delivering the study. This is a collaborative effort led by the University of Oxford and a full list of our study sites is available on the study website. Vaccinations will be taking place across the sites in May and June.

What about after the vaccination?

Some participants will be given an E-diary to record any symptoms experienced for 7 days after receiving the vaccine and if they feel unwell for the following 3 weeks. There is also a weekly survey that participants will be asked to complete about any household exposure to COVID-19.

In order to monitor exposure to COVID-19 in people who do not have symptoms, participants in some areas will be asked to collect swabs at home to be sent to the laboratory for testing.

Following vaccination, participants will attend a series of short follow-up visits. During these visits, the team will check participants’ observations, take a blood sample and review the completed E-diary and questionnaire. These blood samples will be used to assess the immune response to the vaccine.

If participants develop COVID-19 symptoms during the study, they can contact a member of the clinical team, and we will assess them to check whether they have become infected with the virus. If a participant was very unwell, we would call our colleagues in the hospital and ask them to review the volunteer if appropriate.

When will the results be available?

To assess whether the vaccine works to protect from COVID-19, the statisticians in our team will compare the number of infections in the control group with the number of infections in the vaccinated group. For this purpose, it is necessary for a small number of study participants to develop COVID-19. How quickly we reach the numbers required will depend on the levels of virus transmission in the community. If transmission remains high, we may get enough data in a couple of months to see if the vaccine works, but if transmission levels drop, this could take up to 6 months. Recruitment of those who have a higher chance of being exposed to the SARS-CoV-2 virus is being prioritised, such as frontline healthcare workers, frontline support staff and public-facing key workers, in an effort to capture the efficacy data as quickly as possible.

What if it doesn’t work?

A significant proportion of vaccines that are tested in clinical trials don’t work. If we are unable to show that the vaccine is protective against the virus, we would review progress, examine alternative approaches, such as using different numbers of doses, and would potentially stop the programme.

Charlotte Anscombe - Media Relations Manager - Faculty of Medicine and Health Sciences
Email: charlotte.anscombe@nottingham.ac.uk
Phone: 0115 748 4417
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Notes to editors:

The University of Nottingham is a research-intensive university with a proud heritage, consistently ranked among the world's top 100. Studying at the University of Nottingham is a life-changing experience and we pride ourselves on unlocking the potential of our 44,000 students - Nottingham was named both Sports and International University of the Year in the 2019 Times and Sunday Times Good University Guide, was awarded gold in the TEF 2017 and features in the top 25 of all three major UK rankings. We have a pioneering spirit, expressed in the vision of our founder Sir Jesse Boot, which has seen us lead the way in establishing campuses in China and Malaysia - part of a globally connected network of education, research and industrial engagement. We are ranked eighth for research power in the UK according to REF 2014. We have six beacons of research excellence helping to transform lives and change the world; we are also a major employer, proud of our Athena SWAN silver award, and a key industry partner- locally and globally.

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