Detroit’s Henry Ford Health System is the only hospital system in the state to be chosen as a Phase 3 trial site for a COVID-19 vaccine.
The National Institutes of Health announced Monday that Henry Ford would administer the Moderna mRNA-1273 Coronavirus Efficacy vaccine study. The health system is enrolling volunteers into the randomized double-blind study of whether a two-dose vaccine prevents the COVID-19 infection in those exposed to the virus.
About 90 health care systems across the country are enrolling a total of 30,000 volunteer participants. The study will close once enough people are enrolled.
“Henry Ford Health System is proud to be part of the fight against this deadly virus,” says Adnan Munkarah, executive vice president and chief clinical officer of Henry Ford. “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 found the vaccine to be safe. Phase 2 showed the vaccine elicited the body to produce antibodies. Phase 3 will determine whether the immune response is enough to neutralize the virus.
“Our best hope of controlling COVID-19 is with a vaccine,” says Dr. Marcus Zervos, division chief of infectious disease for Henry Ford. “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.”
Usually, vaccines are made from a weakened or inactive virus, but this vaccine is not made from the SARS-CoV-2 virus. It is instead made with messenger ribonucleic acid (mRNA), a genetic code that tells cells how to make a 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.
Some participants may still become infected with SARS-CoV-2 in their everyday activities, despite receiving the two shots, as some will receive a placebo. All participants will have a 50 percent chance of receiving the placebo, a sterile saline solution that does not contain any active vaccine, as opposed to the vaccine.
Anyone age 18 or older who is not immune-compromised, 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; adults who are 65 or older; and adults who are high-risk due to pre-existing medical conditions that are stable at the time of screening.
Those interested can find more information or volunteer here. Members of the study team will reach out and schedule two initial enrollment site visits. The sites for enrollment are at the Henry Ford Hospital Emergency Department in Detroit, New Center One Building, and the HAP building across the street from the main hospital.
After two shots spaced about a month apart, volunteers will visit their enrollment site five more times and talk to study coordinators about 24 times over two years. During that time, participants will be monitored for symptoms of COVID-19 and will be tested to see if they have produced antibodies. If a participant is diagnosed with the virus during their time in the study, the team says it will provide the highest level of care.
“Each participant’s health and safety are our top priorities,” Munkarah says. “Your participation in this trial could help determine whether the vaccine can save lives.”
Henry Ford is a $6 billion integrated health system comprised of six hospitals, a health plan, and more than 250 sites. It was founded in 1915 and has 32,000 employees.