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.