Stop COVID Kentucky: FAQs
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Thank you for your interest in the ENSEMBLE study.


Below you will find answers to frequently asked questions about this study and clinical research in general.

Pre-screening forms for people interested in participating at UK, Baptist Health Lexington, and Norton Healthcare are available here

Grid of illustrated images of diverse adults wearing protective face masks.

Why hasn't the study team contacted me yet?

The study is going to enroll in phases. Your responses to the pre-screening questionnaire regarding your age and health information will help determine which phase you may be eligible for. Enrollment will take place over a three-month period so there may be a delay in when you might be contacted. If your responses to the pre-screening questionnaire indicate that you are not eligible for the study, you may not hear from the study team at all.  


 

1. About This Study


What is the aim of the Phase 3 ENSEMBLE trial?

The Phase 3 randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of Janssen’s COVID-19 vaccine candidate, for the prevention of SARS-CoV-2-mediated COVID-19 in adults aged 18 years and older. SARS-CoV-2 is the virus that causes COVID-19. Participants will receive intramuscular injection of the investigational COVID-19 vaccine candidate as a single dose vaccine, or placebo, on Day 1. Between 30,000 to 60,000 adults from across the globe will take part in the study.

More information is available at ensemblestudy.com

 

What are the characteristics of this investigational COVID-19 vaccine that are different to others in development? 

The vaccine candidate we are investigating leverages Janssen’s AdVac® technology platform, which was also used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates. This AdVac® technology platform has been used to vaccinate more than 110,000 people to date.

There are many types of vaccines under investigation today, including RNA, DNA, and other platforms. The WHO maintains the latest update on the vaccines landscape and provides more information about the differences in the vaccine types. 

 

Can I get COVID-19 from this investigational vaccine?

You cannot get COVID-19 from the investigational vaccine or the placebo. 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.

 

What type of vaccine is the investigational vaccine candidate being evaluated in your COVID-19 vaccine clinical trials? 

The COVID-19 vaccine candidate is an inactivated/non-infective adenovirus vector (similar to a cold virus) which contains a piece of DNA that codes for the coronavirus “spike” (S) protein. 

 

How does the investigational vaccine candidate being evaluated in your COVID-19 vaccine clinical trials work? 

When a person receives the investigational vaccine, the goal (what is being evaluated) is that their cells will make the “spike” (S) protein, which is recognized by the immune system as foreign, stimulating production of antibodies and additional immune responses to fight off the virus. The process creates an immune memory, which ultimately teaches the body to both recognize and attack the virus.

 

What is the status of the Phase 3 ENSEMBLE trial?  

Johnson & Johnson is preparing to resume recruitment in the pivotal Phase 3 ENSEMBLE trial of its investigational Janssen COVID-19 vaccine in the United States after a temporary pause. What does a re-initiation mean for currently enrolled patients and patients looking to participate?  Preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway. Discussions with other regulators around the world to resume the clinical trial program are progressing. Participants looking to get involved should visit https://www.ensemblestudy.com.   Outside of the United States, the investigational Janssen COVID-19 vaccine candidate clinical trials remain paused, as discussions with other regulators around the world are progressing.


Why was the Phase 3 ENSEMBLE trial temporarily paused?  

Johnson & Johnson temporarily paused dosing in all of its COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in one study participant. Following guidelines, the participant’s illness was reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB), as well as Janssen clinical and safety physicians. After a thorough evaluation of a serious medical event experienced by the study participant, no clear cause has been identified. There are many possible factors that could have caused the event. Based on the information gathered to date and the input of independent experts, the Data and Safety Monitoring Board (DSMB), the FDA, and the Company has found no evidence that the vaccine candidate caused the event. 

 

Is this the same clinical event that was observed in the AstraZeneca COVID-19 vaccine clinical trial?

We cannot speak to the details of the clinical event that prompted the temporary pause in AstraZeneca’s clinical trials. 

 

Why was the pause so long? Will there be another pause on this study?

The length of a pause varies in different countries based on the time it takes for relevant health and safety experts to collect the available evidence and conduct a thorough review of all medical information to determine the next steps. While we cannot speak to potential future pauses, we will pause enrollment and vaccinations if a clinical event occurs that is considered potentially related to the investigational vaccine in order to collect the necessary information to determine the cause of the clinical event.

 

What is the role of the Data Safety Monitoring Board (DSMB) in ensuring the study is run in a safe and ethical way?  

The independent Data and Safety Monitoring Board (DSMB) is an independent group of experts that oversee and monitor clinical trials. The members of the DSMB serve in an individual capacity and provide their expertise and recommendations. Experts in this group include clinical research experts, such as physicians and statisticians, and patient advocates who monitor the progress of a clinical trial and review safety and effectiveness data while the trial is ongoing. 

 

Are there any changes to the study oversight and design going forward due to this pause? 

Johnson & Johnson will continue to develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles. The company’s protocol is available here

 

Who is the trial sponsor?


Janssen Vaccines & Prevention B.V. is the trial sponsor.


2. Participation and Safety

 

What is the safety and data transparency protocol for ENSEMBLE?

Information about clinical trials is publicly disclosed in external public registries, such as ClinicalTrials.gov and the EU Clinical Trials Register. The ENSEMBLE protocol is publicly available here.

 

What measures will be put in place to ensure the safety of those involved in the COVID-19 vaccine candidate clinical trials? 

Our primary goal is to ensure the safety and wellbeing of the participants and all those involved in our trials. We are committed to transparency, as well as accurate medical information and protecting medical privacy.

 

What is being done to ensure participants are safe during the pandemic when they are at the study centers?

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:

  • 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

 

Who can participate in the Phase 3 ENSEMBLE clinical trial?

You may be able to participate in the ENSEMBLE 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 a vaccine for COVID-19.

You must meet all other study criteria to take part in the ENSEMBLE Study.

 

How is the Phase 3 trial emphasizing diversity and inclusion? 

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 disproportionally impacted both older people and minority populations. Therefore, clinical research studies 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.

 

What happens after I complete a pre-screening form?

If you are interested in participating, please fill out the form to see if you might be eligible for the study. If you might be eligible, the study team will contact you to 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.

 

What can I expect if I join this 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):

  • Questionnaires about how you’re feeling and, if you experience 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 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.
 

Can I change my mind?

Yes. You can quit the study at any time, for any reason. Even if you begin the study, you can change your mind at any point.

 

Will participants just receive one dose of the vaccine? Will people need an annual COVID-19 vaccine like we do with the flu vaccine? 

Janssen is investigating both a single dose and a two-dose regimen within its global Phase 3 clinical program. However, the ENSEMBLE trial is evaluating only a single dose; for more information on the ENSEMBLE protocol, please visit here

 

How long will participants be monitored? 

All participants will be monitored closely for safety for up to two years after vaccination.


What are the health risks for those involved in this trial? What are the benefits for those involved in this trial? 

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”). It is possible that trial participants may not benefit from the study medication they are assigned to, and the key known risks (potential side effects) as well as potential for unknown side effects, and requirements for participation in a study will be described to participants before participants decide whether to take part. 
 

How much are participants being compensated?  

Volunteers who take part in the study will receive compensation for reasonable travel-related expenses to and from study visits. 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 participants’ daily healthcare routines.
 

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 study will not pay for other medical care or current medication(s) needed to support your daily healthcare routine.

 

What happens if a participant(s) has a clinical event in the trial? 

Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies. Our primary goal is to ensure the safety and wellbeing of the participants and all those involved in our trials.

All of the Janssen COVID-19 vaccine candidate clinical trials have pre-specified guidelines. This means COVID-19 vaccine clinical studies may be paused if an unexpected serious adverse event (SAE) that might be related to an investigational vaccine or study drug is reported so there can be a careful review of all of the medical information before deciding whether to restart the study.  

 

How does this investigational COVID-19 vaccine interact with yearly flu vaccine?

As part of the trial protocol, the trial will evaluate participants’ medical history (including recent flu or pneumococcal vaccination). 

 

What else do I need to consider?

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.

 

I am interested in joining the study 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 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.


 

3. GENERAL QUESTIONS
 

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 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.

 

What are the differences between the phases in the clinical trials?

For information on the different phases of clinical trials, visit here

 

What’s the time frame for starting and completing the trial? How long will Phase 3 last? What's the next step after that? 

The initiation of the ENSEMBLE trial occurred on September 21, 2020. The study was primarily designed to monitor participants until approximately 154 cases of confirmed moderate-to-severe COVID-19 have been seen, and to follow the participants for up to two years. This will allow establishment of vaccine efficacy in line with the statistical requirements detailed in the FDA Guidance Document titled ‘Development and Licensure of Vaccines to Prevent COVID-19”.

 

Why are particular sites selected for the clinical trial? 

Locations of sites are determined in close collaboration with governments and local health authorities. The decision takes into account current disease prevalence, population demographics and regulatory authorities’ requirements. Trial sites are also approved by IQVIA. For more information, please visit https://www.ensemblestudy.com.

 

What qualifies as a “high exposure setting?” 

The Phase 3 study aims to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. In order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and locations that have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated. It is not possible to determine vaccine efficacy without meeting these criteria. Incidence projections per country have been established in collaboration with multiple independent epidemiological and forecasting experts (e.g., from Massachusetts Institute of Technology (MIT), The Institute for Health Metrics and Evaluation (IHME), and others).

 

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, 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 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). 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.

 

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 of volunteers 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.

 

What is Informed Consent?

“Informed Consent” is a process of information exchange before a participant agrees to participate in research. Potential research participants will be asked to read and sign an Informed Consent document. They will also be given instructions, verbally and in writing, question/answer sessions, and other reading materials to assure the potential study participant’s understanding and willingness to voluntarily enroll in the research.

So, before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the risks and benefits, and address your questions.

After all of your questions have been answered, and if you wish to participate, then you will sign a document called the Informed Consent Form to ensure:

  • You agree to volunteer.
  • You understand the study, including the study procedures, risks, and potential side effects of the investigational vaccine or a placebo.
  • You understand that you can leave the study at any time, for any reason.

If you don’t understand the document or what is expected of you by participating in the study, you should continue to ask questions and talk with the study doctor. You are also free to discuss the study with your own doctor, your family, your friends, your religious/spiritual leader, or others that you trust, until you feel you understand. Taking part in the study is your decision.

 

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 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.

 

Participant Concerns, Suggestions, or Questions

It is Institutional Review Board policy that a safe confidential, and reliable channel for current, prospective, or past research participants, their representatives or others, is provided that permits them to discuss problems, concerns, and questions; obtain information; or offer input with an informed individual who is unaffiliated with the specific research protocol.

You may contact ORI Research Compliance Officer's toll-free phone number (1-866-400-9428).  

 

More Resources:

If you have further questions, please contact the study team at stopcovidky@uky.edu.