COVID19 Vaccine

Our study center is currently taking part in a clinical research study called the ENSEMBLE Study, conducted on behalf of Janssen Vaccines & Prevention B.V. The main goal of this study is to see if an investigational vaccine can prevent Coronavirus disease 2019, or COVID-19, in adults.

We are seeking healthy adult volunteers who want to help us in the fight against COVID-19.

What is a clinical research study? A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation that helps to answer important questions about an investigational vaccine or medication. All vaccines and medications must be tested in clinical research studies before they can be approved for use.

Prior to participant enrollment, a clinical research study must be reviewed and approved by an institutional review board (IRB)/independent ethics committee (IEC). An IRB/IEC is an ethics committee that may have a mixture of members with regards to their age, gender, race, disability, religion, and sexual orientation. For example, the US Food and Drug Administration (FDA) requires that an IRB has a diverse membership. As a group the IRB/IEC members have the education and experience to review and assess the medical aspects, science, and ethics of a clinical research study.

Clinical research studies are conducted by doctors and researchers, who follow strict rules and procedures to keep participants as safe as possible. Several tests and assessments are performed throughout clinical research studies to monitor participants’ health.

For more information, please visit www.ensemblestudy.com or contact a member of the study team at 616.965.8348

ENSEMBLE STUDY

By contacting us, you are under no obligation to take part in the study. Taking part in the study is your decision. If you take part, you can quit the study at any time, for any reason.

Are you interested in taking part in this study?

You may be able to participate in this study if you:

are 18 years of age or older
are in good or stable health (you may have underlying medical conditions, if your symptoms and signs are stable and well-controlled).

Additional eligibility criteria will be assessed by the study doctor or staff during the screening process prior to being enrolled in the study and prior to receiving any investigational vaccine. Not all individuals may qualify to participate in the research.

Qualified participants may receive study-related medical care and 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. Your participation in the study will help us learn more about this investigational vaccine.

For more information, please visit www.ensemblestudy.com or contact a member of the study team at 616.965.8348

By contacting us, you are under no obligation to take part in the study. Taking part in the study is your decision. If you take part, you can quit the study at any time, for any reason.

About the ENSEMBLE Study

Currently, there is no approved vaccine for the prevention of COVID-19. The purpose of the ENSEMBLE Study is to determine the efficacy and safety of an investigational vaccine for the prevention of COVID-19. If you take part and complete the entire study, you will be in the ENSEMBLE Study for up to 2 years and 1 month. During this time, you will have up to 8 visits (either at home or at the study center) with the study doctor or clinical research staff. If you are diagnosed with COVID-19 while taking part in the study, you will be asked to provide further information for the study team and may need additional visits. While taking part in the study, you will receive 1 injection of either the 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.

Why is clinical research important?

Clinical research helps doctors and scientists determine the safety and efficacy (whether it works) of an investigational vaccine or medication for use in humans to potentially prevent/treat a condition, disease, or disorder. Research has shown that certain diseases and medications may impact people differently based on their age, gender, and genetic background, including race and ethnicity. For example, 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. This helps ensure that vaccines and medications are generally safe and work for different types of people, especially those most impacted by the disease or illness.