COVID-19 Vaccine Research Trial Enrollment is Now Closed
Recruitment has been completed for this Trial!
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
A highly regulated, FDA and EMA reviewed clinical trial protocol that puts your safety first!
Volunteers from diverse groups were needed to research an investigational vaccine.
Those who qualified may have received:
- Study-related medical care from local doctors at no cost
- The investigational vaccine or placebo at no cost
- Reimbursement for reasonable trial-related travel expenses
Janssen Trial Number: 833-MY1SHOT
Janssen Trial Email: firstname.lastname@example.org
Previous Recruiting Sites:
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)
What is the Janssen Study?
The purpose of this clinical research study was 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 took part in the study.
What was the Expectation?
Eligible participants are in the study up to 2 years and 1 month. They 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 their health. These will include (but are not limited to):
- Questionnaires about how they’re feeling and, if they experienced any COVID-19 symptoms. The questionnaire can be completed electronically via app (phone, iPad) or via a web-based portal on a home computer
- Physical examinations
- Measurements of vital signs (blood pressure, heart rate, breathing rate, oxygen saturation, and temperature)
Qualified participants received study-related medical care and either the investigational vaccine or placebo at no cost. Qualified participants were also reimbursed for reasonable trial-related travel expenses to and from study visits. The study did not pay for other medical care or current medication(s) needed to support their daily healthcare routine.
After they complete the study, if they received the placebo, they may have been offered the investigational vaccine at no cost. However, this depended on the results of the study and may not occur until the study is complete.
The study Groups
In the Janssen Study, they were randomly assigned to 1 of 2 groups and received 1 injection. Depending on which group they were assigned, they may have received 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) was administered into their arm as an intramuscular injection (a technique used to deliver medication into the muscles; the same as the flu shot).
Participants in the Janssen Study joined if they were:
- 18 years of age or older
- In good or stable health (they may have had underlying medical conditions if their symptoms and signs were stable and well-controlled)
- Have not had previously received a vaccine for COVID-19.
Frequently Asked Questions
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 received their care and tests at a study center or doctor's office. We ensured that we were doing all we could to help keep people safe during the COVID-19 pandemic including the following measures:
- Staff and visitors were required to wear masks
- Cleaning and sanitizing for all areas
- Social distancing practices
- Screening questions and temperature checks
- Doctors and staff used personal protective equipment (PPE)
- Telemedicine and telephone appointment options
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.
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.