DETROIT (WXYZ) — Henry Ford Health System is the only hospital system in Michigan chosen as a Phase 3 trial site for the Moderna mRNA-1273 Coronavirus Efficacy (COVE) vaccine study, the National Institutes of Health announced Monday.
Henry Ford is enrolling volunteers into this randomized double-blind study of whether a two-dose vaccine prevents COVID-19 infection in those exposed to the coronavirus.
About 90 healthcare systems across the United States are working competitively to enroll a total of 30,000 volunteers to participate in the Moderna vaccine study. The study will close to volunteers once 30,000 people are enrolled, so signing up at www.HenryFord.com/ModernaVaccine quickly is crucial.
“Henry Ford Health System is proud to be part of the fight against this deadly virus,” said Adnan Munkarah, Executive Vice President and Chief Clinical Officer of Henry Ford Health System. “As one of the region’s major academic medical centers with more than $100 million in annual research funding, Henry Ford is involved in numerous COVID-19 efforts with partners around the world.”
The study’s first two phases involving more than 600 participants showed the vaccine to be safe. Phase 2 showed the vaccine produce antibodies; Phase 3 will determine whether that will provide protection against the COVID-19 virus.
“Our best hope of controlling COVID-19 is with a vaccine,” said Dr. Marcus Zervos, Division Chief of Infectious Disease for Henry Ford Health System. “The Moderna vaccine seems to be very promising. In the initial studies that have been done so far, it looks to be safe and has produced protective antibodies at the level of a natural infection.”
Typical vaccines for viruses are made from a weakened or inactive virus, but the mRNA-1273 study vaccine is not made from the SARS-CoV-2 virus. It is made from messenger ribonucleic acid (mRNA), a genetic code that tells cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system make antibodies to fight the virus. However, people may still become infected with SARS-CoV-2 in their everyday activities, despite receiving the study’s two shots.
All study participants will have a 50% chance of receiving the study vaccine or placebo, a sterile saline solution that does not contain any active vaccine. Anyone age 18 or older who is not immune-compromised or pregnant or planning to become pregnant can volunteer for the study, as long as they have not had COVID-19 or another vaccine or treatment. Researchers are particularly interested in recruiting:
- Those at high risk of COVID-19 infection, defined as adults whose locations or circumstances put them at greater risk of exposure to the virus responsible for COVID-19,
- Adults who are at high risk for severe COVID-19 based on age of 65 years or older
- Adults who are at high risk due to pre-existing medical conditions that are stable at the time of screening.
Those interested can volunteer by filling out the enrollment form on the website.
Members of the COVE study team will then reach out and schedule two initial enrollment site visits.
The health system says at this time, sites for enrollment will be located in Detroit at the Henry Ford Hospital Emergency Department (with a separate entrance), New Center One Building (7th Floor) and at the HAP building (home to the Employee Health clinic) across the street from the main hospital.
After two shots spaced about a month apart, volunteers will visit their enrollment site five additional times and talk to study coordinators about 24 times over two years. During that time, participants will be closely monitored by the study team for symptoms of COVID-19 and will be tested to see if they have produced the antibodies to protect them from the coronavirus. If a participant is diagnosed with COVID-19 during their time in the study, the study team will provide the highest level of care.
“Each participant’s health and safety are our top priorities,” Dr. Munkarah said. “Your participation in this trial could help determine whether the vaccine can save lives.”
Interested participants can volunteer to enroll or learn more about the vaccine trial by visiting www.henryford.com/ModernaVaccine
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