We are inviting you to take part in a COVID-19 Vaccine Study to help assess the safety and effectiveness of an investigational new COVID-19 vaccine. All study-related visits, tests and care, alongside the study vaccine, will be provided at no cost to you. In addition, you will be compensated for your time and travel.
The COVID-19 Vaccine Study is evaluating whether an investigational COVID-19 vaccine may be effective in preventing COVID-19.
All study-related visits, tests and the investigational COVID-19 vaccine will be provided at no cost, and if you qualify, you will be compensated for your time and any travel costs spent on study visits.
What happens if I sign up? We will match you to a clinical study location in your area that needs participants for a COVID-19 Vaccine Study or notify you when one becomes available. The study team will then contact you and you may have the opportunity to participate if you qualify.
If you think you might like to participate in the COVID-19 Vaccine Study or would like more information, please enter your details below so we can see if you might qualify and can contact you about the study. Bear in mind that participation is entirely voluntary. If you do decide to take part in a study, you may change your mind about participating at any time.
In December 2019, a cluster of pneumonia cases were identified as COVID-19. We now know that the virus that caused the early cases in 2019 is the same virus that is responsible for over 108 million cases worldwide today (the 12th of February, 2021).1
The symptoms of COVID-19 are similar to the flu and include sudden fever, cough, shortness of breath – or difficulty breathing – and fatigue (tiredness).2
The symptoms of COVID-19 have been found to be more severe in older age groups, as well as in individuals with hypertension, type 2 diabetes, asthma and chronic obstructive pulmonary disease (COPD).3
Vaccinations may be a safe way to help build protection against infection. Getting an infection like COVID-19 may offer some natural protection – known as immunity. However, experts do not know how long this protection lasts. Vaccinations help to protect you by creating antibodies, which are proteins made by the immune system to fight infections, without having to experience the illness.4
The COVID-19 Vaccine Study is evaluating whether the investigational COVID-19 vaccine, given in two doses 21 days apart, is effective in preventing COVID-19.
A clinical study (also called a clinical trial or research study) is a medical study that helps to answer important questions about an investigational drug, which may include questions about how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
A clinical study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so that people can live happier and healthier lives. Even over-the-counter medications, such as pain medication (like aspirin) that you may have used to counteract a headache, have gone through the clinical research study process before being made available at your local pharmacy.
The COVID-19 Vaccine Study is a Phase 3 study to evaluate whether the investigational COVID-19 vaccine, given in two doses 21 days apart, is safe and effective in preventing COVID-19.
The Phase 3 portion of this study consists of enrolling approximately 30,000 subjects who are generally representative of the study population groups in terms of racial and ethnic diversity and including those at highest risk of severe COVID-19 disease (i.e., the elderly and those with significant comorbidities).
The COVID-19 Vaccine Study will include three different groups of participants, called “study populations”.
Study Population 1 consists of healthy individuals between the ages of 18 to 64. If the participant has a pre-existing health condition, the condition must be under control in order to participate. The study doctor can help to determine if you qualify.
Study Population 2 consists of healthy individuals who are 65 years of age or older. If the participant has a pre-existing health condition, the condition must be under control in order to participate. The study doctor can help to determine if you qualify.
Study Population 3 consists of individuals who are 18 years of age or older, who have one or more conditions that put them at a higher risk of severe COVID-19 infections. The study doctor can help to determine if you qualify.
The conditions for Study Population 3 include, but are not limited to: obesity, hypertension, type 1 or type 2 diabetes, chronic obstructive pulmonary disease (COPD), significant cardiovascular diseases, chronic kidney disease, or conditions causing a patient to be immunocompromised (e.g., treatment-controlled HIV infection, organ transplant recipients or patients receiving cancer chemotherapy).
The study will consist of two periods (Period 1 and Period 2) and all participants will receive the investigational COVID-19 vaccine or the placebo during Period 1. Participants will have one chance out of two (50%) to receive the COVID-19 vaccine in Period 1 and one chance out of two (50%) to receive the placebo in Period 1. During Period 2, participants will receive the opposite of what they received in Period 1. In the end, all participants will have been assigned to receive the COVID-19 vaccine – either in Period 1 or Period 2. Participants will not know in which period they have received the COVID-19 vaccine. During each period (Period 1 and Period 2), participants will receive two injections of the same experimental treatment (placebo or vaccine) 21 days apart.
The study staff will closely follow your symptoms and progress for the duration of the study. Your safety is their top priority.
Research sites participating in this study will have processes in place for following the recommendations of the local public health authorities for the management of COVID-19.
Participants who qualify to take part in the study will be compensated for their time and travel costs spent on study visits. Please discuss this with the study team when they contact you.
There is no cost to participate in the COVID-19 Vaccine Study. If you decide to take part:
The research team will be able to explain more about what the COVID-19 Vaccine Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
We match you to a research site within close travelling distance from your home. If we are not currently running the study in your area, with your permission, we will keep you in our database and contact you once a study in your area becomes available. If, at any time, you decide that you no longer want your information to be stored, you can opt out and we will delete your details.
The COVID-19 Vaccine Study is evaluating whether the investigational COVID-19 vaccine is effective in preventing COVID-19.
This investigational vaccine is produced in a form of coronavirus-like particles, known as CoVLPs, which are about the same shape and size and look very similar to live coronaviruses. However, CoVLPs do not have any viral genetic material and cannot therefore cause the disease. The CoVLPs are combined with an adjuvant before the vaccine is given. An adjuvant is an ingredient that may enhance the body’s immune response to the vaccine and allow for a smaller dose of the vaccine to be given, so that more doses would be available to vaccinate more people, once the vaccine is approved.
You may qualify for the COVID-19 Vaccine Study if you:
All study-related visits, tests and care will be provided by a dedicated study team at no cost to you.
The similarity between CoVLPs and live coronaviruses may help our immune system to recognise and respond to the vaccine particles. The next step in the development of the CoVLP COVID-19 vaccine is to conduct this large clinical study to determine whether the CoVLP COVID-19 vaccine is safe and effective at protecting people from COVID-19.
The COVID-19 Vaccine Study will enrol over 30,000 participants at research sites throughout the UK, North America, Latin America and Europe.
All study-related visits, tests and care, alongside the study vaccine, will be provided at no cost to you.
The study will involve up to 10 planned visits to the clinic for up to approximately 26 months.
Participants who qualify to take part in the study will be compensated for their time and travel.