Join 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 future 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 is currently testing a new vaccine candidate against COVID-19 in adults. The study population is now extended to include adolescent participants and this information is intended for adolescents and parents or guardian of potentially eligible participants.
You/your child can participate in this trial 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 participates in this study will receive either the vaccine candidate VLA2001 or a placebo (a substance that has no therapeutic effect and is used as a control in testing new drugs).
- For participants in the VLA2001-group the vaccine candidate will be delivered in 2 doses, 28 days apart, and a third dose (booster vaccination), 7 months after enrolling into the study (3 injections in total).
- Participants in the placebo-group, will receive 2 doses of placebo, 28 days apart. Seven months after enrolling into the study they will receive 2 doses of the vaccine candidate VLA2001, 28 days apart (4 injections in total).
- The study will take 14 months to complete.
- Study participants must complete a minimum of 8 to 10 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 between 12 and 17 years old.
- Have stable health (meaning that any present condition is not likely to worsen to the point the participant is no longer able to continue 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 participation (if applicable).
This study will investigate the level of antibodies against COVID-19 induced by the vaccine candidate VLA2001 and whether it is safe for use. We will recruit approximately 660 adolescents to help us evaluate the vaccine compared to a placebo.
With this study we aim at answering the following two main questions:
- Is the immune response induced by VLA2001 comparable in adults and in adolescents?
- Is our COVID-19 vaccine candidate VLA2001 safe for adolescents?
What Happens If You/Your Child Are/Is Accepted?
After being accepted to take part in this study, you/your child will be randomly assigned to one of two groups: the first group includes participants receiving the VLA2001 COVID-19 vaccine candidate and the second group, those individuals getting a placebo. Our study will admit a total of 660 participants, who will be split equally (1:1). 330 adolescents will receive VLA2001 and the remaining 330 participants will initially get the placebo only, followed by the vaccine candidate VLA2001 at a later time.
You/your child will not know which treatment is given and neither will the study doctor.
After an initial screening visit, the participant will need to visit the site another 7 to 9 times (possibly more on request). Study-related activities will include physical examinations, COVID-19 testing, and blood and urine samples. In total, the participation is required for approximately 14 months.
University Hospitals Bristol and Weston NHS Foundation Trust
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 death are possible. More than 4 million people worldwide have died from COVID-19 or associated illnesses since the onset of the pandemic, out of approximately 190 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. Based on the different technologies used in their development, the COVID-19 vaccines work differently in the body.
To date approximately 3,150 adults have received at least one dose of VLA2001 vaccine in two ongoing clinical trials. An independent group of experts is regularly reviewing the safety information and to date has not identified any safety concern. Overall, the study showed that VLA2001 was safe and well-tolerated at all dose levels tested.
Why Should I/My Child Participate in COVID-19 Research?
COVID-19 is a global concern. Nearly 2.4% 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, neighbours and ourselves from catching the virus.
Before enrolment in the COVID-19 study, here are some things to consider:
- Participants will receive a COVID-19 vaccination (either with a vaccine candidate, or with a placebo at the initial stage of the study and then the vaccine candidate later), possibly before they would otherwise be eligible to receive one.
- The progress of all participants will be supported every step of the way.
- Your participation could help others.
- Participants in the placebo-group will not receive the vaccine candidate immediately.
- The candidate vaccine may not be as effective as the licensed COVID-19 vaccines.
- You/your child could experience side effects, such as headache, fatigue, muscle pain, or 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, meaning a product currently being researched. 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 it became part of modern healthcare. It truly takes a team, and it all starts with study participants or volunteers.
Large 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 and effective. Investigators analyse results, run lab tests, and follow up with participants for 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 currently being investigated or studied before possible approval for public use by health authorities.
One group will receive VLA2001, the other group will receive placebo (a substance that has no therapeutic effect and is used as a control in testing new drugs).
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 against the inactivated virus. This way, if you are exposed to the virus that causes COVID-19, those antibodies are able to attack the virus, and you may not get sick.
The vaccine in this trial is an 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/your child can quit at any time. There is no penalty and no reason has to be given.
Your (child’s) information will be provided to the participating NHS or private research site, and they will get in touch directly to discuss the study and aspects of participation. Again, the participation can be stopped at any time. There is no penalty, and no reason has to be given.
It is possible that, during the course of this study, participants will become eligible, through the national vaccination roll-out, to receive an approved, nationally deployed COVID-19 vaccine. If this happens, options can be discussed with the study doctors to make an informed choice.