 OCTOBER 29 • 2020 | 33

B

y 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 well 
together, and I couldn’
t be hap-
pier 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 par-
ticipating 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 part-
nered 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 oper-
ationalized mobile unit work, 
worked on writing grants, mak-
ing 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 process-
es and protocols are followed.
The trial delivered the first 
injection to a Michigan resident 
back in August. Half the partic-
ipants receive the study vaccine, 
and half receive the placebo.
“
All of the studies are a dou-
ble-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 informa-
tion on how well the study vac-
cine is working.
“We enter all data into the 
(Moderna) database for them to 
analyze,
” she said. “I would not 
know their process for review-
ing.
”

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 import-
ant 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 

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

HEALTH

PHOTOS COURTESY OF KATE ZENLEA

continued on page 34

Kate Zenlea consults 

with co-workers at 

Henry Ford.

