Kate Zenlea’s Moderna trial is one of the highest enrolling in the country.
By the time the COVID-19 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 really well together, and I really couldn’t be happier with the outcome.”
Detroit is one of 90 sites participating in Moderna’s Phase III trial, and one of the highest enrolling for participants in the country, with hundreds of people enrolled in the trial. 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.
But once COVID-19 hit, the initiative knew they had to shift their mission and 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 awarded to be 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 remote. From home, she operationalized mobile unit work, worked on writing grants, making presentations, managing budgets, creating workflows and more.
When the Moderna opportunity came about, Zenlea was able to do the prep remotely, including hiring the staff and securing clinic space.
Once the trial actually started, it was apparent that 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 different sites and making sure all of the sites are following all of the regulatory processes and protocols.
The trial delivered the first injection to a Michigan resident back in August for any “COVID-19 investigational product”, which is the term referring to the not yet FDA-approved study vaccine.
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.
As a result of it being a double-blinded study, the investigators, Zenlea included, have 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.”
Hundreds of people enrolled and thousands signed up for the pre-screening to be a part of the trial. Pre-screening was for those who were simply interested in participating. Enrolled participants are those that met the eligibility criteria and were selected to participate.
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 type of VIP list. We really made sure that if we were prioritizing anyone, we were prioritizing minorities who came from our community.”
Black enrollment, especially, has been low in the COVID vaccine trials, because of mistrust in the American health system after such racist medical incidents as the Tuskegee experiment.
When the President of Dillard University, a historically Black college in New Orleans, sent out a letter urging the campus community to consider enrolling in a COVID-19 vaccine trial, it was met with hundreds of posts of fierce backlash all over their social media platforms.
“Our children are not lab rats for drug companies,” said one post. “I can’t believe a HBCU would do this to our people,” said another response. “Tuskegee, Tuskegee. … Me and mine aren’t first in line,” said another reply.
Zenlea couldn’t give any specific statistics about Black enrollment in her trial, but said her trial was featured on a Moderna webinar for all clinic sites that was focused on diversity and inclusion, given their status as a leader in the area.
Most clinical trials of a study vaccine, especially Phase III clinical trials, take about 12-18 months to set up. The Zenlea-led Moderna trial was set up in less than two months, because of how active the virus became.
“I think it was about seven weeks, start to finish, from our enrollment date to when we started setting this up,” Zenlea said.
The Moderna trial is 24 months long, and requires multiple in-person visits, COVID swabs, blood draws, the injections of the study vaccine, and many follow-up visits and safety calls throughout.
According to Zenlea, an analysis will be done once Moderna has enough people they’ve enrolled and data gathered where they can statistically say if the study vaccine is effective or not. If they determine the study vaccine is effective, the study would be “called” or “ended”, those who received the placebo would receive the vaccine, and the vaccine would go to market.
“It is possible that the sponsor (Moderna) will have enough enrolled participants and enough data to determine if the study vaccine is effective or not before the end of the study timeline, which is initially set for 24 months,” Zenlea said.
Zenlea and her team have not received any official word yet on if the study will be “called” before the end of the trial period, though.
Zenlea will also be the managing director of the Johnson & Johnson COVID-19 Phase Three vaccine trial in Detroit, which she initially hoped would begin in the next few weeks, before news came out on October 13 that Johnson & Johnson is pausing its trial while the company investigates a participant’s “unexplained illness.”
Zenlea and her team are aware of that issue, and she says J&J is still investigating the “unexplained illness” and has halted all study activities, internationally, until they know more.
“We still have plans to launch this trial at our site once the safety hold has been lifted, and we continue to work closely with the sponsor. Of course, we will not start any study activities until it is completely safe to do so,” Zenlea said.
Adverse events are expected in all clinical trials and the J&J study is no different, according to Zenlea.
“There are several clinical indicators that could trigger a ‘study pause’, planned or unplanned, and they are always investigated in an abundance of caution,” she said.
There are over a hundred national sites for Johnson & Johnson, and their enrollment target collectively is about 60,000, about double of what Moderna was.
Dr. Marc Zervos, head of the infectious disease division for HFHS and the principal investigator on the Moderna Phase III Covid vaccine trial in Detroit, knows how important Zenlea has been to the trial.
“Kate has remarkably built Henry Ford Health System’s COVID vaccine trial from the ground up…the work she is doing is truly admirable,” Zervos said. “[The vaccine trial] is one of the most incredible achievements I’ve ever seen in my lifetime and it is largely due to Kate’s leadership. There are very few people in the country who could’ve accomplished what she’s done.”
The other principal investigator is Dr. Paul Kilgore, a senior scientist with the GHI and faculty of Wayne State University.
Zenlea is also Jewish, growing up going to Temple Beth El in Bloomfield Hills and now belonging to Congregation Etz Chayim in Huntington Woods.
Zenlea is proud to represent her community, along with her husband David and one-year old daughter, Shoshana.
“It’s a huge part of our identity,” Zenlea said. “To be Jewish and to be leading this, it just makes me proud that I can showcase this as a young Jewish professional of what our capabilities are and what I’m able to do, and I hope it’s making the community proud as well.’
Zenlea also suspects that even when the vaccine comes out, we’re still going to be practicing social distancing, mask-wearing and hand-washing measures for some time, due to it taking time for everyone to get vaccinated.
She believes caring for one’s community with those precautions runs true to her Jewish values as well.
“It’s not just me, it’s the community,” Zenlea said. “We’re a part of something larger. That’s true if you’re referring to being Jewish or if you’re referring to helping to end a global pandemic. We’re all part of a larger story, and the story here is we have to make sure we’re protecting ourselves and our community.”
Correction (10/29/20): An earlier version of this article incorrectly stated Kate Zenlea’s title.