What exactly is this study?
Currently, there is no FDA-approved vaccine to fight COVID-19. The Moderna mRNA vaccine Cove Study is a Phase 3 study to evaluate the safety and efficacy of this vaccine among many people. If this is proven to be effective, it could be the first vaccine available to prevent COVID-19.
Who can participate in this study?
This study is open to anyone aged 18 and older, and those who are not immunocompromised. Since this requires multiple site visits over up to two years, preference will be given to those who live or work in southeast Michigan.
How do I sign up for this study?You can enroll in this study by filling out the volunteer form, located here, or by clicking on “I’d like to volunteer for the study”. You can also email the study team at firstname.lastname@example.org with any questions.
Why is this called the COVE StudyTM™?
For this study, the word “COVE” is an acronym for: Coronavirus Efficacy and Safety Study. The name implies protection from COVID-19, as coves can be thought of as sheltered inlets.
Since we don’t know if you can get COVID-19 more than once, can I enroll even if I was diagnosed with COVID-19 in the past?
No, you cannot. Those who have had COVID-19 are excluded from this study.
What if I’ve had COVID-19 but didn’t know it?
As part of the screening process, all participants will be tested for COVID-19 and COVID-19 antibodies. Antibodies are created by your body in response to a virus. This is how your body fights off the virus. If you test positive for either test – meaning you have an active infection or have had COVID-19 in the recent past – you cannot participate in the study.
What is my time commitment for this study?
The study length is 25 months and includes approximately 7 visits to the clinic and 24 phone calls. The overall time commitment spans 25 months, from the time of your first screening until your final appointment.
During that time, you will be asked to come in for an initial screening, which can last up to 2 hours. This screening includes a COVID-19 nasopharyngeal swab test, antibody test and blood sample. Following that, you will come in for two appointments to receive an injection; these appointments are at least 28 days apart. Following each injection dose you will receive what we refer to as “safety calls” to check in with you on any side effects. You will receive this call 7, 14 and 21 days after each dose.
What if I develop COVID-19 during the course of this study?
If you are diagnosed with COVID-19, you will have 2 additional clinic or home visits and daily telemedicine visits by videoconference or telephone for 14 days after illness visit or until your symptoms have resolved, whichever is later.
If I participate, where will I have to go for these appointments?
At this time, sites for enrollment will be located in Detroit at the Henry Ford Hospital Emergency Department (with a separate entrance); Henry Ford Health System Corporate Headquarters; 1 Ford Place, Detroit, 48202; and at the HAP building (home to the Employee Health clinic) across the street from the main hospital.
Other than the injections what other procedures and commitments does this study include?
In addition to the screening tests and the two injections, you will have your blood collected 6 additional times. You will also be asked to log information daily into an electronic diary (eDiary) for 7 days after each injection. This diary is an application (or “app”) that can be downloaded onto your smartphone. If you do not have a smartphone, an eDiary device can be provided to you, based on availability. You will be trained on how to complete the eDiary. You will have to complete the diary every day (preferably at the same time each day in the evenings) for 7 days after each of the 2 injections. Completion of the daily symptoms should take about 5-10 minutes each day.
If I enroll in this study, am I certain to receive the vaccine?
No, this is a randomized double-blind study. Randomization means that each person has an equal chance of receiving the actual Moderna mRNA vaccine or the saline injection. Half of the volunteers (50%) will receive the vaccine and half will receive a saline solution placebo. Double-blind means that neither you nor study team members know whether you received the vaccine or the placebo. This is done to protect the integrity of the study.
What if I enroll in the study and end up getting the placebo? Does this mean I 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, you have the option of stopping your participation in this study and getting that vaccine. This is the case regardless which group you are in – vaccine or placebo. However, if this study is not yet finished (it may be concluded early if the results show overwhelmingly that the vaccine is effective), the study team will not be able to tell you which group you were in – the vaccine or placebo.
What are the known side effects of the Moderna mRNA vaccine?
As with any vaccine, people can react differently. To date, more than 300 adult subjects have received at least 1 dose of the mRNA-1273 study vaccine. There have been no serious side effects observed or reported by subjects in these studies. The great majority of side effects reported by subjects to date have been mild.
What are the risks of receiving this 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 afterwards. To minimize risk, participants will be monitored for 30 minutes after each injection. They will also be able to log any adverse side effects into the eDiary which is monitored by study team members.
Are there any known long-term side effects?
Because all 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.
What happens if I experience side effects?
If you experience side effects, the study team will be there for you to help manage them. Should side effects become serious and require care, any costs incurred will be paid by the Moderna mRNA study, provided there is a direct link between the symptoms and the vaccine.
If I get COVID-19 during the trial am I still considered a participant?
If you get COVID-19 during the 25-month course of this study you will still be considered enrolled, as long as you continue to make all of your appointments-.
Is it possible for me to get COVID-19 from this vaccine?
This vaccine contains no active or killed virus particles. There is no chance you can develop COVID-19 from this vaccine.
If I participate in this study, can I still get the seasonal flu vaccine?
Yes, you can still get the seasonal influenza vaccine if you participate in this trial. The Moderna mRNA vaccine will not protect you from seasonal influenza. It is still recommended that you receive the seasonal flu vaccine.
What are the benefits of participating in this clinical study?
The bottom line is that you may not directly benefit from this research, particularly if you receive the placebo. However, some of the possible benefits that may be expected include early receipt of a vaccine that can protect you from COVID-19. Although there is no assurance that you will benefit from your participation in this study, the information learned from your participation may help others in the future. Imagine being a part of a vaccine process that could potentially help millions of people protect themselves and their families from the devastation of COVID-19. That is what we believe is the overriding benefit of your participation in this study.
Has this vaccine been proven to be effective in the earlier phases?
No. This is the first Phase 3 trial to assess effectiveness of the Moderna mRNA vaccine. Previous phases have been conducted to analyze the safety and antibody response of the vaccine. Thus far, Phase 1 and 2 results indicate that the vaccine is safe. Phase 2 showed an ability to create an antibody response against the virus. Antibody response is what protects someone from getting the virus, but that’s what Phase 3 is designed to determine.
What if I previously participated in the WHIP COVID or SPIT clinical trials/studies at Henry Ford? Can I also enroll in this study?
Yes, you can! Your past participation in those studies does not impact your eligibility for this study. That said, if you are still actively participating in the WHIP COVID study, you will have to complete that and wait about a month before enrolling in this.
Will I have to pay for the screening, the vaccine or the follow-up visits?
No, you will not have to pay for screening, the vaccine or follow-up visits. There is no cost to you for participating in this study.
Will I receive payment for participating in this study?
Those who participate in this trial will receive compensation based on attending each appointment and completion of the study. Details will be communicated directly to each study participant when they have completed the screening process for participation.
Why is Henry Ford participating in this clinical study?
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 study. 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.
How many participants can Henry Ford enroll?
There is no minimum number of participants to be enrolled at Henry Ford. Nationwide, there are about 90 health systems participating that will enroll up to 30,000 total participants in this study, and each site is competing to enroll volunteers. So volunteering quickly is advised. Henry Ford is the only trial site in the state of Michigan.
If I am a Henry Ford employee, do I have to participate in this study?
Absolutely not, but we certainly hope you will consider it! All participation is voluntary. If you decide to participate but at any point during the 25-month commitment you change your mind, you can stop.