COVID-19 Vaccine Research Trial is Now Enrolling
COVID-19 Vaccine Research Trial is Now Enrolling
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
Join this highly regulated, FDA and EMA reviewed clinical trial protocol that puts your safety first!
Those who qualify may receive*:
There is no obligation, so see if you may qualify now.
*In a clinical research study, participants may receive an investigational medication that has not been approved by regulatory authorities, an approved comparator product or intervention, or an inactive substance called a placebo, depending on study design (all referred to as “study medication”). You may not benefit from the study medication you are assigned to, and the key known risks (potential side effects) and requirements for participation in a study will be described to you before you decide whether to take part. Depending on the study, reasonable reimbursement may be made for trial-related travel expenses. The length of the study may vary.
Janssen Trial Number: 833-MY1SHOT
Janssen Trial Email: email@example.com
Downtown: CTU COVID Research Center (143 S Liberty Street, New Orleans, LA 70112)
Uptown: Tulane Uptown Campus (6324 W Claiborne Ave, New Orleans, LA 70125)
West Bank: West Jefferson Medical Center (4413 Wichers Dr., Marreo, LA 70072)
East: New Orleans East Hospital (5620 Read Blvd, New Orleans, LA 70127)
The purpose of this clinical research study is to determine the efficacy (whether it works) and safety 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, and genetic background, including race and/or ethnicity. For example, COVID-19 has disproportionately 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 and vaccines are generally safe and work for different types of people, especially those most impacted by the disease or illness.
About 60,000 adults from across globe will take part in the study.
Eligible participants will be in the study up to 2 years and 1 month. You will have up to 8 visits (either at home or at the study center) 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):
Qualified 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 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.
In the Janssen Study, you will be randomly assigned to 1 of 2 groups and will receive 1 injection. Depending on which group you are assigned, you may receive 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.
The study injection (investigational vaccine or placebo) will be administered into your arm as an intramuscular injection (a technique used to deliver medication into the muscles; the same as the flu shot).
You may be able to participate in the Janssen Study if you:
You must meet all other study criteria to take part in the Janssen Study. More details will be posted soon about how you can join this study!
A vaccine produces immunity that helps protect the body. The vaccine under evaluation in this study is an investigational vaccine, which means that it is still in the testing and evaluation phase. It is not licensed for use in the general public. You cannot get COVID-19 from the investigational vaccine or the placebo.
Clinical trial participants in this study will receive their care and tests at a study center or doctor's office. We will ensure that we are doing all we can to help keep people safe during the COVID-19 pandemic including the following measures:
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 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. These groups include black persons, people of Hispanic and Latino origin, and American Indians/Alaska Natives.
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 study with your own doctor, your family, your friends, your religious/spiritual leader, or others whom you trust, until you feel you understand. We can help you make an informed decision on whether a clinical trial is right for you but taking part in the study is entirely your decision.
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 costly 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, 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.
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 purpose of an IRB/IEC is to help protect the rights, safety, and well-being of people taking part in clinical research studies.
The IRB/IEC reviews the study’s documentation to:
• assess whether the study benefits outweigh the study risks
• understand all procedures that will be undertaken to reduce risks
• make sure that participant-facing items, such as the Informed Consent Form, state all the potential risks and benefits in a way that can be easily understood.
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 enrollment, a clinical trial must be reviewed and approved by an institutional review board (IRB). An IRB is an ethics committee made up of doctors, researchers, and a lay audience independent from the trial.
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 patients. 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.
If you are interested in participating, please fill out the form to see if you might be eligible for the study (you will be told immediately). If you might be eligible, we will match you to a clinical research site in your area that is participating in the ENSEMBLE Study 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 the study and receiving any investigational vaccine or placebo. Not all individuals who pass the questionnaire may qualify to participate in the research.
Volunteers who take part in the study will receive compensation 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 study 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.
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 study will not pay for other medical care or current medication(s) needed to support your daily healthcare routine.
It is up to you to decide if you want to take part in the ENSEMBLE Study. Participation in this study 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.