Human Trials Have Begun – A Volunteer Receives The First Dose Of An Experimental Zika Vaccine
The National Institute of Allergy and Infectious Diseases has injected two human volunteers with an experimental DNA-based Zika vaccine, Director Anthony Fauci announced today, a month ahead of its projected schedule for vaccine development.
“If it’s a home run, we’ll know pretty quickly,” Fauci said, adding
that if it is successful, phase 2 trials could begin as early as
January.
Human trials of another DNA-based vaccine created by Inovio
Pharmaceuticals started in Miami a few days ago, but Fauci stressed
that those DNA inserts are different from the ones the his agency is
using.
“This vaccine includes a small piece of DNA with genes that code for
Zika-virus proteins,” Fauci said. It’s injected via a coil spring
injector into the deltoid muscle of the arm, where the body’s cells
read the DNA and create virus-like particles that should activate
the immune system to create antibodies.
A total of 80 volunteers ages 18 to 35 will receive the vaccine
by the end of August at three study sites in Bethesda, Maryland,
Baltimore and Atlanta. The volunteers will be broken into three
groups that will receive the same dose at different intervals
over a 20-week period.
After the first injection, volunteers will be required to
return for follow-up visits over a 44-week period to monitor
their health.
The agency stressed the safety of the vaccine, noting that
“DNA vaccines do not contain infectious material — so they
cannot cause a vaccinated individual to become infected with
Zika — and have been shown to be safe in previous clinical
trials for other diseases.”
If preliminary results show effectiveness, Fauci said, the
National Institute of Allergy and Infectious Diseases has
enough doses of the vaccine on hand to move from phase 1 to
phase 2 trials. However, it does not have enough money to
plan and administer the phase 2 study, he said, adding that
Congress needs to act on the Obama administration’s request
for additional funding to fight Zika.
That sentiment was echoed today by White House press
secretary Josh Earnest: “If Republicans continue to
obstruct funding for the Zika virus, then that’s going
to limit our ability to rapidly develop the kind of
vaccine that, next summer or the summer after that,
could start protecting the American people from the Zika
virus and limit the risk associated with this particular
disease.”
If phase 2 happens as planned, Fauci said, he thought
the earliest the vaccine might be used would be in early
2017, with FDA approval.
“The target of the vaccine will be women of childbearing
age and their sexual partners,” he said, “to protect
their unborn children from birth defects.”
Zika has been shown to be responsible for an alarming
increase in microcephaly, in which babies are born with
small brains and heads, as well as other hearing, vision
and developmental disorders.
Because it’s well-known that Zika does the most
damage in the first trimester of a pregnancy, Fauci
stressed that vaccinating girls before they reach
puberty in areas hard-hit by Zika is the ultimate
goal.
“In the real world, women are most vulnerable before
they even know they are pregnant,” he said. “So we
need to vaccinate as young as we can possibly get
them.”
Source(s):
edition.cnn.com
cnn.com
nih.gov
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