Enrolling Locals in COVID-19 Vaccine Trial Kate Zenlea’s Moderna trial is one of the highest enrolling in the country. DANNY SCHWARTZ STAFF WRITER
B
y the time the COVID19 pandemic hit America in January, Kate Zenlea of Huntington Woods had been working for Henry Ford Health System’s (HFHS) Global Health Initiative (GHI) for about three years. Now, she is the managing director of the hospital’s Phase III clinical vaccine trial for the biotech company Moderna. Zenlea had never worked on a clinical trial before. “When I was selected to be the managing director to lead this trial, it was very daunting for me,” she said. “But I had a very supporting
team, and we all worked well together, and I couldn’t be happier with the outcome.” In addition, Dr. Erica Herc, a Jewish infectious disease expert in Bloomfield Hills, is one of the study’s investigators and played a large role in enrollment and its design. Detroit is one of 90 sites participating in Moderna’s Phase III trial, and one of the highest enrolling for participants in the country. Those with active COVID-19 are not eligible for the trial. The GHI’s mission prior to the pandemic was to work with
vulnerable populations at home and abroad by addressing public health threats and inequities, and implementing public health strategies around the world. Once COVID-19 hit, the initiative shifted its mission to figure out how to address it in a localized way. Early on, the initiative partnered with the Detroit Health Department to implement and expand COVID-19 rapid testing in Detroit. When they were doing the testing, the Infectious Diseases Department of Henry Ford was chosen as one of the sites for the Moderna COVID-19 Phase III vaccine trial. Zenlea built the team from the ground up, hiring about 45 nurses, research assistants and epidemiologists, who all report to her. Three sites are running for Moderna, all within the Henry Ford campus in Detroit. Zenlea herself is a Type 1 diabetic, so when the pandemic hit, she was a part of the at-risk population and quickly went
PHOTOS COURTESY OF KATE ZENLEA
HEALTH
Kate Zenlea consults with co-workers at Henry Ford.
remote. From home, she operationalized mobile unit work, worked on writing grants, making presentations, managing budgets and creating workflows. Zenlea was able to do the prep for the trial remotely, including hiring the staff and securing clinic space. Once the trial started, Zenlea needed to be there in person. Now her day consists of quality control, putting out fires that come with managing 45 staff members at three sites and ensuring all regulatory processes and protocols are followed. The trial delivered the first injection to a Michigan resident back in August. Half the participants receive the study vaccine, and half receive the placebo. “All of the studies are a double-blinded study, meaning I as an investigator do not know what they got, and of course the participants do not know if they got the (study vaccine) or the placebo,” Zenlea said. Because it is a double-blinded study, Zenlea has no information on how well the study vaccine is working. “We enter all data into the (Moderna) database for them to analyze,” she said. “I would not know their process for reviewing.” ENROLLING PARTICIPANTS Hundreds of people enrolled, and thousands signed up for the pre-screening to be a part of the trial. Zenlea takes pride in being one of the highest enrolling sites in the country for Moderna, and a leading site in enrollment for minorities. “That was really important to us, especially from our background in public health and working with vulnerable and marginalized populations,” Zenlea said. “We really wanted to make sure, if the GHI was leading this work, that we were going to do what was true to us — we did not prioritize any continued on page 34 OCTOBER 29 • 2020
|
33
