Help the Fight
From the start of the COVID-19 pandemic, researchers have been working to develop a vaccine against this disease. Help us to test a further vaccine candidate against COVID-19.
Now Looking For Healthy Participants
There are several COVID-19 vaccines, both approved and in development. Each one uses a different technology to prevent people from getting sick after being infected by the virus. Valneva’s Phase 3 clinical trial will test a new vaccine candidate against COVID-19; you could participate in this trial in order to confirm the safety of Valneva’s vaccine candidate and test its ability to induce antibodies as a protection against the virus.
What to Expect:
- Everyone who will participate in this study will receive depending on the age either the vaccine candidate VLA2001 or the licensed vaccine AZD1222 against COVID-19.
- The vaccine candidate or vaccine will be delivered in two doses, 28 days apart.
- The study will take 13 months to complete.
- Study participants must complete a minimum of 7 to 8 visits; additional visits may be required.
- Selected study participants will be compensated for their time and participation.
To be eligible to participate, you must:
- Be 18 years or older.
- Have stable health (meaning that any condition you have is not likely to worsen to the point you cannot participate in the study).
- Be able to attend all study visits and maintain an e-diary for 7 days after each injection.
- Agree to use highly effective contraception during your participation.
This study will investigate the level of antibodies against COVID-19 induced by the vaccine candidate VLA2001 and whether it is safe to use. We will recruit 4,000 people to help us evaluate this vaccination compared to a licensed COVID-19 vaccine.
With this study we will aim at answering the following two main questions:
- How does the level of antibodies induced by VLA2001 compare to the antibody levels induced by the AZD1222 COVID-19 vaccine?
- Is VLA2001 vaccine safe?
What Happens If You Are Accepted?
If you are accepted to take part in this upcoming study, you will be randomly assigned to one of two groups: those receiving the VLA2001 vaccine candidate and those getting AZD1222. The split is 3:1, so 3,000 people will receive VLA2001 and the remaining 1,000 participants will get AZD1222.
If you are under 30 years of age you will be assigned to receive the VLA2001 vaccine.
If you are 30 or older you will be randomly assigned to receive either VLA2001 or AZD1222. You will not know which vaccine you receive and neither will the study doctor.
After an initial screening visit, you will need to visit the site another six times (possibly seven on request). Study-related activities will include physical examinations, COVID-19 testing, and blood and urine samples. In total, your participation is required for approximately 13 months.
- NIHR Cambridge Biomedical Research Centre – Cambridge University Hospitals NHS Foundation Trust
- Lakeside Healthcare
- Nottingham University Hospitals NHS Trust - Queen's Medical Centre
- Chelsea and Westminster Hospital NHS Foundation Trust
- Panthera Enfield
- Royal Free London NHS Foundation Trust
- St George's University Hospitals NHS Foundation Trust
- University College London Hospitals NHS Foundation Trust - UCLH
- The Newcastle upon Tyne Hospitals NHS foundation trust - Freeman Hospital
- Northumbria Healthcare NHS Foundation trust - North Tyneside General Hospital
- Blackpool Teaching Hospitals NHS Foundation trust - Victoria Hospital
- Warrington and Halton Teaching Hospitals NHS Foundation Trust
- Northern Care Alliance Salford Royal NHS Foundation Trust
- Panthera Preston
- Panthera Rochdale
- University Hospital Southampton NHS Foundation Trust
- Royal Surrey County Hospital NHS Foundation Trust
- University Hospitals Plymouth NHS Trust- Derriford Hospital
- University Hospitals Bristol and Weston NHS Foundation Trust
- North Bristol NHS Trust - Southmead Hospital
- University Hospitals Birmingham NHS Foundation Trust – Queen Elisabeth Hospital
- University Hospital Coventry & Warwickshire NHS Trust – Walsgrave General Hospital
- Cheadle Community Hospital, Royal Walk, Cheadle, Stock-On-Trent, Straffordshire
- The Rotherham NHS Foundation Trust - Barnsley Hospital
- NHS Greater Glasgow and Clyde - Queen Elizabeth University Hospital
- NHS Lothian - Western General Hospital
COVID-19 is a coronavirus-induced disease caused by SARS-CoV-2. Common symptoms include fever, cough, dyspnoea (shortness of breath), muscle and body ache, fatigue, loss or change of smell and taste, as well as diarrhea. Serious complications or deaths are possible. More than 2.7 million people worldwide have died from COVID-19 or associated illnesses since the onset of the pandemic, out of approximately 123 million confirmed cases.
In an effort to control the spread of COVID-19, researchers around the world have been working to develop vaccines. Today, there are a few approved COVID-19 vaccines and more in development. Each one works in the body differently.
The vaccine candidate VLA2001 has been developed using the same manufacturing platform as that used for a commercial vaccine to prevent Japan Encephalitis B. This commercial vaccine has been approved by regulatory authorities worldwide (including the American Food and Drug Administration [FDA] and the European Medicines Agency [EMA]) and is similar in composition to VLA2001, with a good safety profile consistent with findings from pre-licensure clinical studies.
Why Should I Participate in COVID-19 Research?
COVID-19 is a global concern. Nearly 1.6% of the world population has had a confirmed case of the virus and more are being infected every day. Together, we can work to limit the spread and fight against COVID-19, protecting our families, friends, neighbors and ourselves from catching the virus.
Before you enroll in the COVID-19 study,
here are some things to consider:
- You will receive a COVID-19 vaccination (either with a vaccine candidate or with a licensed vaccine), possibly before you would otherwise be eligible to receive one.
- Your progress will be supported every step of the way.
- Your participation could help others.
- The candidate vaccine you might receive may not be as effective as the licensed COVID-19 vaccines.
- You could experience side effects, such as injection site tenderness.
Clinical studies are how drugs, treatments, and vaccines are studied to ensure that they are safe and effective before they become available to the public. Participants volunteer to receive an investigational product. Then, they are checked by medical staff to see how they react to that substance. Researchers look at those results and determine whether the product works and if it is safe.
Every single vaccine, prescription drug, or therapeutic treatment on the market today went through a series of clinical studies before they became part of modern healthcare. It truly takes a team, and it all starts with study participants or volunteers.
Vast teams work together. Volunteers participate, giving their time and their bodies. Researchers work with test subjects to make sure the prevention or treatment is safe as well as effective. Investigators analyse results, run lab tests, and follow up with participants months, sometimes years, after they stop receiving doses of the investigative product. Regulators review those findings before ultimately granting the drug or vaccine approval.
The vaccine candidate being tested in this study, VLA2001, is called an investigational vaccine because it is being investigated or studied before possible approval for public use by health authorities.
The other vaccine is a licensed vaccine, which means that it has already been approved for use by the health authorities.
No. It is impossible to get COVID-19 from a COVID-19 vaccine.
While the vaccine does hold some of the same germs that cause COVID-19, they are weakened and made inactive so that they cannot make you sick. Instead, your body produces antibodies to those harmless germ cells. This way, if you are exposed to COVID-19, those antibodies will attack the germs, and you may not get sick.
One of the two vaccines in this trial is the investigational vaccine, which means that the exact side effects or the commonalities of those issues have yet to be determined.
We expect that some participants will experience typical vaccination site reactions, such as pain, swelling, tenderness or redness at the injection site. In addition, there is a risk of systemic adverse reactions, like headache, myalgia (muscle pain), tiredness, nausea, arthralgia (joint pain), malaise (a general feeling of being unwell), fever (high temperature) feverishness, or chills. Most side effects after vaccination are mild to moderate and will resolve within a few days of vaccination.
As with all investigational studies, the study vaccine and study procedures in this investigation may involve unknown risks. All medications can have both temporary and permanent side effects and can cause unforeseen adverse reactions.
You can quit at any time. There is no penalty, and you do not have to give any reason.
Your information will be provided to the participating NHS or Panthera (private research) site, and they will reach out to you directly to discuss the study and aspects of participation. Again, you can stop at any time. There is no penalty, and you do not have to give any reason.
We plan to test VLA2001 against AZD1222, which was developed by AstraZeneca and was approved for emergency use in the United Kingdom in December 2020. It has been tested in several clinical trials. Between April 23 and December 6, 2020, over 24,000 people received the AstraZeneca vaccine and only 332 of them contracted COVID-19.
It is possible that during the course of this study, you will become eligible, through the national vaccination roll-out, to receive an approved, nationally deployed COVID-19 vaccine. If this happens, you can discuss it with the study doctors to make an informed choice about whether you should take the approved COVID-19 vaccine or continue with the study.
Yes, in line with the latest guidance in the UK and further feedback from the regulators, all under 30’s will be assigned to receive the VLA2001 vaccine as long as you are already 18 years old.