The ENSEMBLE 2 Study is evaluating an investigational vaccine for the prevention of COVID-19.
We are looking for adults in the Lexington area to take part in the study. You may be able to join if you are 18 years old or older and are in good or stable health. Even if you have underlying medical conditions, you still may qualify if your conditions are stable and well-controlled.
Take the pre-screening survey below, and the study team may contact you about participating.
What are the ENSEMBLE studies?
The purpose of the ENSEMBLE clinical research studies is to determine the safety and efficacy (whether it works) of an investigational vaccine for the prevention of COVID-19. This investigational vaccine is being evaluated in people 18 years of age or older.
Research has shown that certain diseases and medications may impact people differently based on their age, gender, race, and ethnicity. In many countries, COVID-19 has disproportionally impacted both older people and minority populations. Therefore, clinical research studies often require large and diverse numbers of volunteers to participate in a single study; sometimes thousands are needed to obtain reliable information. Large numbers of participants help ensure that medications and vaccines are generally safe and work for various types of people, especially those most impacted by the disease or illness.
If you take part in one of the ENSEMBLE Studies, you will be in the study for up to 2 years and 3 months. You will have up to 10 visits (either at home, the study center, or clinic) with the study doctor or clinical research staff.
Several tests and assessments will be performed to monitor your health. These will include (but are not limited to):
ualified participants will receive study-related medical care and either the investigational vaccine or placebo at no cost. Qualified participants will also be reimbursed for reasonable trial-related travel expenses to and from study visits. The study will not pay for other medical care or current medication(s) needed to support your daily healthcare routine.
After you complete a study, if you received the placebo, you may be offered the investigational vaccine at no cost. However, this will depend on the results of the study and may not occur until the study is complete.
The Study Groups
If you qualify for one of the ENSEMBLE Studies, you will be randomly assigned by chance (like flipping a coin) to 1 of 2 groups within the study. Depending on which group you are assigned, you will receive either investigational vaccine or placebo. A placebo looks just like the investigational vaccine and is given the same way, but instead of containing an active vaccine it contains a saline (salt) solution with no active ingredients. During your participation, you will either receive 1 or 2 investigational vaccine injections OR 1 or 2 placebo injections. During the study, neither you nor the study staff will know which group you are in. In a medical emergency, the study staff can quickly find out which group you are in.
The study injections (investigational vaccine or placebo) will be administered into your arm as an intramuscular injection (a technique used to deliver vaccine into the muscles, the same as the flu shot).
You may be able to participate in one of the ENSEMBLE Studies if you:
You must meet all other study criteria to take part in the ENSEMBLE Studies.
1. Can the investigational vaccine give me COVID-19?
You cannot get COVID-19 from the investigational vaccine or the placebo.
A vaccine produces immunity that helps protect the body. The vaccine under evaluation in these studies is an investigational vaccine, which means that it is still in the testing and evaluation phase. It has not been approved by the Food & Drug Administration (FDA) or regulatory agencies in other countries for use by the general public.
2. What precautions are being taken at the study centers to help prevent me from getting COVID-19?
Clinical trial participants in these studies will receive their care and tests at a study center, doctor's office, or during home visits. We will ensure that we are doing all we can to help keep people safe during the COVID-19 pandemic including the following measures:
3. Could I be at increased risk of COVID-19?
According to the Centers for Disease Control and Prevention (CDC), everyone is at risk for getting COVID-19 if they are exposed to the virus. However, some people are more likely than others to become seriously ill. Those include older adults and people with underlying medical conditions. Some racial and ethnic minority groups may be at increased risk of contracting COVID-19 or experiencing severe illness, regardless of age.
4. What if I am interested in joining the ENSEMBLE Studies but I'm not sure what I have to do?
If you don't understand what is expected of you, you should continue to ask questions and talk with the study doctor. You can also discuss the studies with your own doctor, your family, your friends, your religious/spiritual leader, or others whom you trust, to have a good understanding of the study. We can help you make an informed decision on whether a clinical trial is right for you but taking part in a study is entirely your decision.
5. How is pandemic research different from regular vaccine research?
Vaccine clinical research studies can take 10–15 years to complete during normal times. Research and development steps are often completed one after the other, which is why it is a very lengthy process. However, during the current global COVID-19 pandemic there is an urgent need to speed up vaccine research. Clinical research study timelines can be compressed by overlapping some research and development steps. Another way to speed up the process of finding a vaccine that works, without compromising safety, is to test as many investigational vaccines as possible. For this reason, collaboration during pandemics between vaccine developers and national/international health organizations can be beneficial.
6. What is a clinical research study?
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational vaccine or treatment, conducted by doctors and researchers. Prior to participant enrolment, a clinical trial must be reviewed and approved by an institutional review board (IRB) or an Independent Ethics Committee (IEC). An IRB/IEC is an ethics committee made up of doctors, researchers, and a lay audience independent from the trial. The IRB/IEC, in partnership with the sponsor and other regulatory agencies, helps to protect the rights, safety, and well-being of people taking part in clinical research studies.
All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities and if approved, given to people. Without people taking part in these studies, we would have no new medications/vaccines. According to the US Food and Drug Administration (FDA), the inclusion of racial and ethnic minorities in clinical research helps ensure that the medications or vaccines are generally safe and effective for many types of people.
Researchers who conduct the study are required to follow strict rules to keep participants as safe as possible. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.
7. What is an IRB (Institutional Review Board)/IEC (Independent Ethics Committee)?
An IRB/IEC consists of 5 or more members. It is made up of doctors, researchers, and non-scientific members; some of the non-scientific members must be people who have never worked as a healthcare professional or clinical researcher or been involved in the management of clinical research. Only members who are impartial, i.e. are independent of the sponsor of the study and the investigator, can provide opinion or vote on any study-related matters.
IRB/IEC members represent diverse experience, perspectives, and expertise. They also aim to represent the interests of the local population. The IRB/IEC, in partnership with the study sponsor and other regulatory agencies, helps to protect the rights, safety, and well-being of people taking part in clinical research studies.
The IRB/IEC reviews the study's documentation to:
8. What happens if I sign up?
If you are interested in participating, please fill out the form to see if you might be eligible for one of the ENSEMBLE Studies. If you might be eligible, we will match you to a clinical research site in your area that is participating in one of the studies and help you schedule your first appointment. Please note that additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to you being enrolled in one of the studies and receiving any investigational vaccine or placebo. Not all individuals who pass the questionnaire may qualify to participate in the research.
9. Will I receive compensation for travel or for my health care?
Volunteers who take part in one of these studies will receive reimbursement for reasonable travel-related expenses to and from study visits. Please discuss this with the study team when they contact you. Qualified participants will receive study-related medical care and either the investigational vaccine or placebo at no cost. The studies will not pay for other medical care or current medication(s) needed to support your daily healthcare routine. During the study, you will be closely monitored by the study team.
10. Is there a cost to participate?
There is no cost to participate. Qualified participants will receive study-related medical care and either the investigational vaccine or placebo at no cost. The studies will not pay for other medical care or current medication(s) needed to support your daily healthcare routine.
11. What else do I need to consider?
It is up to you to decide if you want to take part in the ENSEMBLE Studies. Participation in these studies is voluntary. Your decision whether to participate in a study will not affect your current or future care with your regular doctors. If you decide to participate, you are free to withdraw at any time.
It is important to remember that participating in a COVID-19 vaccine study does not mean that you can ignore personal prevention measures, including:
12. Where will I need to go for clinical trial visits?
The ENSEMBLE Studies are conducted at doctors' offices, medical centers, community hospitals, and clinics. They may be run at your local community hospital or doctor's office, or at medical centers at large universities or health facilities. Where you would need to go for your clinical trial visits will vary depending on your location.
13. Will I be paid for taking part?
You will not be paid for taking part in this study. However, you will be compensated for your time and reimbursed for travel expenses, such as meals and parking.Complete Pre-screening Survey Now »