Help the Fight
The COVID-19 pandemic has impacted nearly every aspect of life. Enrolment for healthy adults to participate in a COVID-19 vaccine study sponsored by Valneva Austria GmbH is now closed.
The study participants will help prevent the spread of COVID-19.
Right now, researchers are investigating a COVID-19 vaccine. They need to confirm its safety and test its effectiveness as a protection against the virus.
What to Expect:
- Everyone who takes part in this study will receive two doses of a study vaccine.
- The study participants had to have a few tests to make sure that they are eligible to participate.
- Study participants must complete seven visits over seven months, additional visits may be required.
- Selected study participants are be compensated for their time and participation.
To be eligible to participate, the study participants must be:
- Between 18 to 55 years of age.
- Generally healthy with a Body Mass Index (BMI) of 18-30.
- Willing to install (and use) an eDiary app on your smartphone.
Our study, VLA2001-201, is testing a new vaccine candidate to prevent COVID-19 across several hospitals in the UK. We are evaluating this investigational vaccine to confirm that it is safe and tolerable for the users.
We want to carry out two things:
- 1. Is this vaccine safe?
- 2. Does the vaccine induce an immune response to potentially prevent COVID-19?
What Happened If The Study Participant Was Accepted?
Participants will be randomly assigned and evenly divided between three groups, each receiving the investigational vaccine either in the low, medium, or high concentration dose. Participation in the study is cost-free, at no costs and study participants will be reimbursed for the participation.
So, the chance of receiving a specific dosage is 1 in 3. The study participants will not know which dose they receive, and neither will the study doctor.
After the initial screening visit, the study participant will be required to visit the site six more times to check the progress. Study-related activities will include physical examination, COVID-19 testing, blood and urine samples. In total, the participation is required for about 8 months.
University Hospitals Bristol and Weston NHS Foundation Trust
University Hospitals Birmingham NHS Foundation Trust
The Newcastle upon Tyne Hospitals NHS Foundation Trust
COVID-19 is a coronavirus-induced disease caused by SARS-CoV-2. Common symptoms include fever, cough, dyspnea (shortness of breath), muscle and body ache, fatigue, loss or change of smell and taste, as well as diarrhoea, serious complications or deaths are possible. Roughly 2.2 million people worldwide have died from COVID-19 or associated illnesses since the onset of the pandemic, out of approximately 100.4 million confirmed cases.
The virus is easily transmitted, and the incubation period is short. It ranges from 2 days to as long as 14 days (5 days is considered average) until symptoms first appear. The problem is that there is no known treatment and COVID-19 symptoms are non-specific, meaning that they vary from person to person. Some people will be utterly asymptomatic, while others could develop severe pneumonia or ARDS (acute respiratory distress syndrome).
In this study, investigators will test an investigational vaccine to see if it is safe and inducing antibodies against SARS-CoV-2.
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 drug being tested in this study is an investigational vaccine because it is a vaccine that is being investigated or studied.
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.
If you have more questions or want to understand the science behind vaccines, click this link for a primer on vaccines from the Centres for Disease Control and Prevention (CDC).
The vaccine is currently under investigation, so the exact side effects or the commonalities of those issues have yet to be determined. We expect that some participants will experience vaccination site reactions, such as swelling or redness at the injection site, and the risk of an adverse reaction.
We realize that study participation can take time. We compensate our participants throughout the clinical study to help offset the travel costs and other incidentals. People who complete all required visits will receive a total of £600. Any additional visits, e.g. in case of a suspected COVID-19 infection, will be reimbursed too.
Your information will be provided to the participating NHS facilities, 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.
The samples will be tested then destroyed. Any backup samples will be stored in the UK for a period of up to 12 months after the end of the study. The results of the study will be published in the scientific press.
The study participant can absolutely quit at any time. There is no penalty, and the study participant does not have to give any reason.
The news about approved vaccines is encouraging. Tremendous efforts are being made to find a way out of this pandemic.
Although this is a significant step forward, there are still several other COVID-19 vaccine studies with different strategies and vaccine types ongoing or about to start. It is also important to understand that different vaccines work in different ways. There is still much research needed about which vaccines work best for COVID-19 and which ones are best for certain groups of people (e.g. elderly people, etc.). We also need to collect information on the effectiveness of these different vaccines (e.g., preventing severe infection, preventing infections as a whole, preventing transmission). More questions need to be answered about these vaccines, such as type of administration (e.g., injection), strength and number of doses, and, last but not least, long-term safety.
The study participants are free to leave at any time. It is a personal choice. However, leaving the study will not influence when a study participant would be able to receive an approved vaccine.
Nevertheless, we ask that the study participants complete the study, continue receiving the investigational vaccine and share data on health and potential COVID-19 infection with the research team. This way, study participants will contribute to the global efforts of researches and participants. The study participants support the identification of effective vaccines and help make them available to everyone as fast as possible, bringing us closer to the end of this global COVID-19 pandemic.