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 along with the study vaccine will be provided at no cost to you. In addition, compensation for time and travel will be provided. No health insurance is required to participate.
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 receive compensation for time and travel related to 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 information below so we can see if you may qualify and can contact you about the study. Keep 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 of 2019, a cluster of pneumonia cases were identified, 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 (12th 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 the 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 sickness.4
The COVID-19 Vaccine Study is evaluating whether the investigational COVID-19 vaccine, given in 2 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 – these may include 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 people can live happier and healthier lives. Even over-the-counter medications, such as pain medication (for example, aspirin) that you may have used to counteract a headache, have gone through the clinical research study process before they were 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 2 doses 21 days apart, is safe and effective in preventing COVID-19.
The Phase 3 portion of this study is to enroll approximately 30,000 subjects who are generally representative of the study population groups in terms of racial and ethnic diversity and to include those at highest risk for 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 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 determine if you qualify.
Study Population 3 consists of individuals, 18 years of age or older, who have one or more conditions that put them at a higher risk for severe COVID-19 infections. The study doctor can help 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. At the end, all participants will be 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 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 time and travel related to 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 a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information 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 so-called Coronavirus-like particles (CoVLPs) that are about the same shape and size and look very similar to the live coronaviruses. However, CoVLPs do not have any viral genetic material and therefore can not 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 or your insurance company.
The similarity between the CoVLPs and live coronaviruses may help our immune system recognize and respond to the vaccine particles. The next step in 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 enroll over 30,000 participants at research sites throughout North America, UK, Latin America, and Europe.
All study-related visits, tests and care, along with 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 receive compensation for time and travel.