COVID-19 Vaccine

For over a century, Johnson & Johnson has actively engaged in fighting global outbreaks from TB to HIV and Ebola. Our knowledge and experience, successes and set-backs alike, inform everything we’re doing today to help eradicate COVID-19.

We are committed to delivering a safe and effective COVID-19 vaccine to the public on a not-for-profit basis for emergency pandemic use pending clinical studies and regulatory authorizations. Through our Janssen Pharmaceutical Companies of Johnson & Johnson, we are currently recruiting for our Phase 3 clinical studies known as ENSEMBLE, which are designed to evaluate the safety and effectiveness of our investigational COVID-19 vaccine candidate for the prevention of COVID-19.

We invite you to learn more about our ENSEMBLE studies, our focus on safety and our commitment to diversity in clinical trials. Individuals interested in learning if they qualify to participate in our ENSEMBLE studies should click here. (By clicking this link, you will leave and go to a third-party web site not governed by the privacy policy.)

Information on Our ENSEMBLE Studies

Our Innovative Vaccine Technology Platform—AdVac®

Our cutting-edge proprietary technology is the driving force behind our strong research and vaccine development pipeline, helping the global health community better prepare for and combat life-threatening infectious disease outbreaks.

FAQs About Our ENSEMBLE Clinical Studies

  • Can the investigational vaccine give me COVID-19?

    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. You cannot get COVID-19 from the investigational vaccine or the placebo.
  • 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:
    • Staff and visits will be required to wear masks
    • Cleaning and sanitizing for all areas
    • Social distancing practices
    • Screening questions and temperature checks
    • Doctors and staff will use personal protective equipment (PPE)
    • Telemedicine and telephone appointment options
  • 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.
  • 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.
  • 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 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, 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.
  • What is an IRB/IEC?

    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:
    • 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 in a way that can be easily understood.
  • 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 enrollment, 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.
  • 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.
  • Will I receive compensation for travel or for my healthcare?

    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.
  • 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.
  • 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:
    • Wearing masks
    • Social distancing (keeping a distance of 2 meters/6 feet)
    • Hand washing, which may include the use of alcohol-based hand rub/hand sanitizer
  • 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.
  • 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.
Volunteers From Diverse Groups Are Needed to Research an Investigational COVID-19 Vaccine. You are now leaving Please note that by clicking this link, you’ll be leaving and going to a third-party website not governed by the privacy policy.

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