Clinical Trial 45067

Orlando, FL 32819


Summary:

Journey towards a COVID-19 vaccine: a cause that unites us all

Local researchers are looking for people from diverse groups who may be interested in taking part in the ENSEMBLE 2 clinical research study so we can find a vaccine that works for different types of people. This study is being reviewed and approved by an independent committee made up of doctors, researchers, and general members from the community.

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 medications are generally safe and work for different types of people, especially those most impacted by the disease or illness.

This study is evaluating an investigational vaccine for the prevention of COVID-19. A vaccine produces immunity that may protect the body. The investigational vaccine in this study is still in the testing and evaluation phase. It has not been approved regulatory authorities for use by the general public.


You may be eligible to participate in the 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)

·       have not previously received an investigational vaccine for COVID-19.


Qualified Participants May Receive:

Qualified participants will receive study-related medical care and either the investigational vaccine or placebo at no cost. After you complete the 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.

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.


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.