What exactly is this vaccine trial?
The Janssen Pharmaceutical Companies of Johnson & Johnson is conducting a Phase 3 clinical research study called the ENSEMBLE trial. This is an international vaccine trial to evaluate a single-dose investigational vaccine for the prevention of COVID-19 . Currently, there is no vaccine to fight COVID-19. The ENSEMBLE trial will evaluate the safety and efficacy (effectiveness) of the investigational vaccine among many people.
Janssen is conducting the vaccine trial and will manufacture the vaccine if it is approved by the U.S. Food and Drug Administration (FDA). Up to 60,000 adults across three continents will be enrolled in the trial, with participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States. The trial will last two years and one month
How can I take part in this vaccine trial?
The first step is to complete the Pre-screening Form, located on HenryFord.com/JandJvaccine. Once you submit this form, our research team will review your answers and contact you if you are selected for the next step in trial participation, when you will come to Henry Ford for an appointment.
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.
Are specific types of people needed for this vaccine trial?
The trial sponsor, the Janssen Pharmaceutical Companies of Johnson & Johnson, is aiming to have significant representation from communities that have been disproportionately impacted by COVID-19. Some of these groups were selected because they have a higher likelihood of exposure to the COVID-19 virus. Others were selected because data shows they have been affected by the virus in higher numbers than average.
At the Henry Ford test site, we hope to have many volunteers who are:
- Over age 60 years
- Individuals with chronic health conditions
- Nursing home workers and residents
- First responders (for example: police officers, fire fighters, EMS)
- Essential/critical infrastructure workers (for example: transportation, power, water, and hospital healthcare workers)
However, this vaccine trial is open to anyone age 18 years or older who is not immunocompromised.
What happens at the first appointment?
Volunteers will come to One Ford Place in Detroit, Henry Ford’s corporate administrative center. First, they will take part in an informed consent process. The researcher will give the volunteer information about the vaccine trial, and the volunteer can ask questions and be sure they understand all the information before agreeing to take part.
Next, participants will answer questions about their health history. After the research staff confirms that a participant is eligible for the trial, the participant will provide a nasal sample and blood sample for testing. The investigational vaccine will then be given and the participant will be monitored for 15-30 minutes afterwards.
Back home, participants will answer questions two times per week to monitor for new symptoms or health concerns that could be related to COVID-19. Participants will receive phone calls throughout the vaccine trial based on the symptoms they report using an assessment tool that research staff will monitor. Some participants will complete an eDiary for seven days after they receive the investigational vaccine.
How many more appointments are there? What will happen on these visits?
After two weeks, two months, six months and one year, participants will come back to give a blood sample. During some of the other follow-up clinic or home health visits, blood samples, in addition to nasopharyngeal, nasal swabs or saliva samples will be taken.
Why is it called a “Phase 3” vaccine trial?
Clinical development of a vaccine is a multi-phase process. In Phases 0, 1 and 2, the vaccine is tested on small groups of people. These phases assess safety, side effects, the dosing, and efficacy. Pending conversations with regulatory authorities and if the data supports, trials may then move to the next phase of testing.
The ENSEMBLE trial is a Phase 3 trial. In this phase, studies enroll 100 or more people, assess side effects and effectiveness of the vaccine, and are usually randomized (some people get the drug, others receive a placebo). This helps researchers understand whether results are due to the investigational vaccine, not other factors (bias). Every patient is watched closely. The trial will be stopped or paused if there any safety signals.
In Phase 4, researchers continue to test drugs after they have been approved by the FDA. Several thousand people are usually involved, the main objective is to study the long-term risks and benefits of using the drug and to discover any rare side effects.
What are the potential side effects of the investigational vaccine?
As with any vaccine, people can react differently. Reported side effects to-date are similar to those people experience after a flu shot. The side effects most often reported were pain at the injection site, malaise (not feeling well), fatigue (feeling tired), headache, and muscle pain. Most side effects reported by subjects to date have been mild. As with any investigational vaccine/medicine, there is the potential for more severe side effects and adverse events that are unknown. The study team will discuss this in more detail during the Informed Consent Process.
How will researchers know the investigational vaccine works?
This is what the study is looking to determine. There will be two groups in this investigational vaccine trial: One will receive the investigational vaccine, the other will receive a placebo (no active ingredient/saline). The results of the placebo group will be compared with the results of the investigational vaccine group. Researchers will know the investigational vaccine works if fewer members of the vaccine group contract COVID-19 during the trial. In addition, blood samples will show that participants have antibodies that could potentially fight COVID-19 infection if the person were exposed to the virus.
Will I have to be exposed to COVID-19?
No, participants will not be deliberately exposed to COVID-19 as part of this vaccine trial.
Where will vaccine trial participants go for their appointments?
They will visit Henry Ford Health System’s Corporate Headquarters, located at One Ford Place, Detroit, 48202. Free, convenient parking is located in a lot just across Third Street from the One Ford Place building. Look for signs, and park only in the designated lot. You’ll be required to sign in to the building and get a guest pass at Security, which is at the Third Street, second entrance. Look for a sign outside this entrance. The trial site is located on the first floor, and directional signs will clearly mark the way. Ask Security to direct you if you need assistance. Click here for a map.
How many participants are being enrolled?
Nationwide, there are about 240 health systems participating that will enroll up to 60,000 total adults in this trial.
Can Henry Ford employees participate in this vaccine trial?
Yes! Henry Ford employees can decide to participate, if eligible. All participation is voluntary. At any point during the 25-month commitment they change their minds, they can stop.
Do volunteers get paid for participating in this vaccine trial?
Those who participate in this trial will receive compensation for time and travel. Details will be communicated directly to each participant when they have completed the screening process.
Do participants pay for the screening, the investigational vaccine or the follow-up visits?
No, they do not have to pay for screening, the investigational vaccine or placebo or follow-up visits. There is no cost for participating in this vaccine trial.
Will I get COVID-19 from the investigational vaccine?
No, this investigational vaccine contains no active or killed virus particles. There is no chance participants can develop COVID-19 from this vaccine.
How long will the vaccine trial go on?
The trial will go on for one year, followed by an additional year of long-term follow up. The maximum length of time a person will be involved is two years and one month after the investigational vaccine is given.
Will all the volunteers in the trial receive the investigational vaccine?
No, this is a randomized double-blind trial. Only half the people receive the actual vaccine, and neither the volunteer or research team knows who received the vaccine and who did not. Key words:
- Randomization: Each person has an equal chance of receiving the investigational vaccine or a saline injection that has no effect on the body. Half of the volunteers (50 percent) will receive the investigational vaccine and the other half will receive a saline solution placebo.
- Placebo: A harmless substitute for the real medication, delivered in the same way as the actual medication.
- Double-blind: Neither participants nor research team members know whether participants received the investigational vaccine or the placebo. This is done to protect the integrity of the trial and eliminate bias.
When will I find out if I received the investigational vaccine or a placebo?
After the investigational vaccine trial is concluded, you will receive notice via a letter or email telling you whether you received the investigational vaccine or the placebo.
What if a participant enrolls in the vaccine trial and ends up getting the placebo? Does this mean they won’t be able to get a publicly available vaccine until after the 25 months have passed?
If another vaccine becomes publicly available before this trial has been completed, participants have the option of stopping participation in this trial and getting that vaccine. This is the case regardless which group participants are in – vaccine or placebo. However, if this trial is not yet finished the research team will not be able to tell participants which group participants were in – the vaccine or placebo.
What are the risks of receiving this investigational vaccine?
Other than common side effects of any vaccine – such as low-grade fever, soreness at the site of the injection or slight fatigue – there are some rare but serious side effects that include an immediate allergic reaction, or an increase in risk of developing COVID-19 if exposed to the virus soon after receiving the investigational vaccine. Because this is an investigational vaccine, there may be side effects that are unknown, these may be mild, moderate or severe. Participants will be monitored for 30 minutes after the injection. They will also be able to log any adverse side effects into the eDiary, which is monitored by research team members.
Are there any known long-term side effects?
Because all investigational COVID-19 vaccines in development are on accelerated paths, there has not been an opportunity to gather extensive long-term research, including side effects. Thus far, the majority of side effects have been mild.
If someone gets COVID-19 during the trial, are they still considered a participant?
If a participant gets COVID-19 during the 25-month course of this trial, they will still be considered enrolled, as long as they continue to make all appointments.
If someone participates in this vaccine trial, can they still get the seasonal flu vaccine?
Yes, participants can still get the seasonal influenza vaccine if they are in this trial. If you have already had the flu shot, you can participate in the ENSEMBLE trial if your flu shot was given more than 14 days ago. In other words, at least 14 days must pass between getting the flu shot and the Janssen investigational COVID-19 vaccine. If you haven’t yet received a flu shot and want to volunteer for this trial, go get your flu shot as soon as possible!
What are the benefits of participating in this clinical vaccine trial?
Participants may not directly benefit from this research, particularly if they receive the placebo. Although there is no assurance that participants will benefit from inclusion in this trial, the information learned from that participation may help others in the future.
Why is Henry Ford participating in this clinical vaccine trial?
Because of Henry Ford’s rich history of research and our intense desire to find a way to prevent COVID-19 infection, Henry Ford enthusiastically raised its hand to facilitate this vaccine trial. Also weighing into this decision was the heavy impact COVID-19 played in the Detroit community and in Southeast Michigan, including the toll it took on Henry Ford frontline healthcare workers.