By Peter Loftus
Johnson & Johnson plans to launch by late September what
could become the largest clinical trial of a coronavirus vaccine to
date, enlisting up to 60,000 people world-wide to test whether its
experimental shot safely protects from Covid-19.
The targeted enrollment, reported on a government database and
confirmed by the company, is double the size of other pivotal
studies that have started recently or are expected imminently for
vaccines developed by Moderna Inc., Pfizer Inc. and AstraZeneca
PLC.
It is unclear why J&J is planning a much bigger late-stage
trial than other companies.
A J&J spokesman said the company wants "to enroll a robust
number of participants who are representative of those populations
affected by Covid-19," and to determine the safety, efficacy,
durability and optimal dosing regimens of the vaccine.
The late-stage, or phase 3, coronavirus vaccine trials depend on
a certain number of subjects being exposed to the virus to see if
the vaccinated subjects were protected against Covid-19 symptoms
compared with the unvaccinated.
William Schaffner, infectious-disease specialist and professor
of preventive medicine at Vanderbilt University School of Medicine,
said reaching the numbers needed to detect whether the vaccine is
working could happen more quickly if more people are enrolled.
"It will certainly speed up the evaluation process," said Dr.
Shaffner, who serves on a liaison committee to a federal
vaccine-advisory panel, and is not involved in designing the
trial.
J&J is using epidemiology and modeling data to predict and
plan study locations with high incidence rates of Covid-19.
The company, based in New Brunswick, N.J., is among several
front-runners in the global race for a vaccine that could help beat
back the deadly global pandemic.
Its vaccine uses a weakened common cold virus to deliver genetic
instructions for human cells to manufacture a protein found on the
surface of the new coronavirus. Researchers say this should trigger
an immune response that can fight off the virus.
In July, J&J started its first human study of the vaccine,
code-named Ad26. COV2. S, in Belgium and the U.S.
For the phase 3 study, some subjects will be given a single dose
of the vaccine while others will receive a placebo, according to
the federal database. Researchers will track whether the vaccinated
have lower rates of Covid-19 featuring moderate to severe symptoms
than the unvaccinated.
The study will be conducted at nearly 180 locations in the U.S.
and eight other countries where transmission rates are high,
including Brazil, Chile, the Philippines and South Africa,
according to a posting on a federal database of clinical
trials.
In the U.S., J&J's vaccine will be tested in 28 states,
including those with high transmission rates like Texas, Florida
and California that will each have multiple study sites.
Many of the sites are part of a national network for
investigating Covid-19 drugs and vaccines funded by the National
Institutes of Health, according to a spokeswoman for the National
Institute of Allergy and Infectious Diseases.
The company has started to recruit subjects, the J&J
spokesman said. The study will follow the subjects for more than
two years, but preliminary results could become available much
sooner.
The company might have initial results by the end of this year,
a J&J executive has said. If results prove the vaccine works
safely and the U.S. government clears the vaccine, J&J plans to
make its first batches available for potential emergency use in
early 2021, the spokesman said.
J&J recently signed a $1 billion contract with the federal
government to supply 100 million doses for the U.S.
The company said last week it will collaborate with the U.K.
government for a global phase 3 study to test a two-dose regimen of
the vaccine, which will run in parallel to the single-dose
study.
Separately, Pfizer Inc. and BioNTech SE on Thursday reported
additional results from a small, early-stage study of two
experimental coronavirus vaccines, including the vaccine they are
now testing in a large phase 3 study.
The results, posted to the preprint server medRxiv, showed that
the vaccine candidate now in phase 3 testing induced immune
responses in study subjects. The results haven't yet been reviewed
by outside experts.
Study subjects received two doses of the Pfizer-BioNTech
vaccine, code-named BNT162b2, three weeks apart. Researchers found
it induced a key component of the immune system, neutralizing
antibodies to the virus, at levels that were more pronounced in
people ages 18 to 55 than in people 65 to 85. But the responses in
the older subjects were still higher than antibody levels seen in
the plasma of people who had Covid-19, according to the paper.
In the early-stage study, people who received BNT162b2 had lower
rates of systemic reactions like fever than the other vaccine that
Pfizer and BioNTech tested in the study. The companies are not
advancing the other vaccine.
The ongoing phase 3 study is designed to test whether the immune
responses translate into actual protection from Covid-19.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
August 20, 2020 11:40 ET (15:40 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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