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.
How do people sign up for this study?
We are fortunate to now have more volunteers that can be enrolled in the trial, so we are no longer accepting volunteers for this study. We are grateful that our community has responded so overwhelmingly to our call for volunteers.
Who is participating in this study?
This study was 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. If you are currently participating, we thank you for your generous efforts to find a vaccine for COVID-19.
Why is this called the COVE Study™?
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, are people being enrolled even if they were diagnosed with COVID-19 in the past?
No, those who have had COVID-19 are excluded from this study.
What if they 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. Those who test positive for either test – meaning you have an active infection or have had COVID-19 in the recent past – cannot participate in the study.
What is the 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 the first screening until your final appointment.
During that time, participants 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, participants will come in for two appointments to receive an injection; these appointments are at least 28 days apart. Following each injection dose participants will receive what we refer to as “safety calls” to check in with participants on any side effects. Participants will receive this call 7, 14 and 21 days after each dose.
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.
What if participants 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.
Where do participants 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’sCorporate Headquarters at 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, participants will have blood collected 6 additional times. Participants 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 a smartphone. If participants do not have a smartphone, an eDiary device can be provided, based on availability. Participants will be trained on how to complete the eDiary. Participants 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 volunteers enroll in this study, are they 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 participants nor study team members know whether participants received the vaccine or the placebo. This is done to protect the integrity of the study.
What if a participant enrolls in the study 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 study and getting that vaccine. This is the case regardless which group participants 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 participants which group participants 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 participants experience side effects?
If participants experience side effects, the study team will be there 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 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 study, they will still be considered enrolled, as long as they continue to make all appointments.
Is it possible for participants to get COVID-19 from this vaccine?
This vaccine contains no active or killed virus particles. There is no chance participants can develop COVID-19 from this vaccine.
If someone participates in this study, can they still get the seasonal flu vaccine?
Yes, participants can still get the seasonal influenza vaccine if they are in this trial. The Moderna mRNA vaccine will not protect people from seasonal influenza. It is still recommended that participants receive the seasonal flu vaccine.
What are the benefits of participating in this clinical study?
The bottom line is that participants may not directly benefit from this research, particularly if they receive the placebo. However, some of the possible benefits that may be expected include early receipt of a vaccine that can provide protection from COVID-19. Although there is no assurance that participants will benefit from inclusion in this study, the information learned from that participation may help others in the future. This vaccine process 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 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 about those who previously participated in the WHIP COVID or SPIT clinical trials/studies at Henry Ford? Are they also able to be enrolled in this study if the Moderna study team calls them?
Yes! Past participation in those studies does not impact eligibility for this study. That said, those still actively participating in the WHIP COVID study will have to complete that and wait about a month before enrolling in this.
Do participants pay for the screening, the vaccine or the follow-up visits?
No, they do not have to pay for screening, the vaccine or follow-up visits. There is no cost for participating in this study.
Do volunteers 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 are being enrolled?
Nationwide, there are about 90 health systems participating that will enroll up to 30,000 total participants in this study.
Are Henry Ford employees participating in this study?
Yes! All participation is voluntary. Henry Ford employees can decide to participate. But if at any point during the 25-month commitment they change their mind, they can stop.