34 | OCTOBER 29 • 2020
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 com-
munity 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 spe-
cific statistics about Black enroll-
ment 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 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,
” 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 anal-
ysis will be done once Moderna
has enough people enrolled
and data gathered where they
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 vac-
cine 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 man-
aging 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 com-
pany investigates a participant’
s
“unexplained illness.
”
Zenlea and her team are
aware of that issue, and she says
J&J is investigating the “unex-
plained illness” and has halted
all study activities, internation-
ally, 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 col-
lectively is 60,000, about double
that of Moderna’
s.
Dr. Marc Zervos, head of the
infectious disease division for
HFHS and the principal investi-
gator 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 investiga-
tor is Dr. Paul Kilgore, a senior
scientist with the GHI and fac-
ulty 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 precau-
tions 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.”
continued from page 33
Kate Zenlea’s
vaccine study
focuses on
inclusion of
the minority
population.