Jewish Researcher Leads Detroit COVID-19 Phase III Vaccine Trials

HEALTH

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

By 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

Kate Zenlea consults with co-workers at Henry Ford.

PHOTOS COURTESY OF KATE ZENLEA

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 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 from page 33 type of VIP list. We made sure we were prioritizing minorities who came from our community.”

Black enrollment, especially, has been low in the COVID vaccine trials, because of the community’s 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 over their social media platforms.

“Our children are not lab rats for drug companies,” said one post. “I can’t believe a HBCU [Historically Black Colleges and Universities] would do this to our people,” said another response.

Zenlea couldn’t give any specific statistics about Black enrollment in her trial, but said her trial was featured on a Moderna webinar 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 Zenlealed 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,” she said.

GETTING RESULTS

The Moderna trial runs 24 months 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 enrolled and data gathered where they

Kate Zenlea’s vaccine study focuses on inclusion of the minority population.

can statistically say whether the study vaccine is effective. 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 that the study will be “called” before the end of the trial period.

Zenlea will also be the managing director of the Johnson & Johnson COVID-19 Phase III vaccine trial in Detroit, which she initially hoped would begin in the next few weeks, before news came out on Oct. 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 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 more than 100 national sites for the J&J trial, and their enrollment target collectively is 60,000, about double that of Moderna’s.

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.

JEWISH VALUES

Zenlea grew up going to Temple Beth El in Bloomfield Hills and now belongs to Congregation Etz Chayim in Huntington Woods. Zenlea is proud to represent her community, along with her husband, David, and 1-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.”

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