U.S. Department of Health and Human Services

NATIONAL INSTITUTES OF HEALTH

NIH News

National Institute of Allergy
and Infectious Diseases (NIAID)
http://www.niaid.nih.gov/

FOR IMMEDIATE RELEASE
Tuesday, December 13, 2004

CONTACTS:
Linda Joy
301-402-1663
ljoy@...

FIRST U.S. SARS VACCINE TRIAL OPENS AT NIH

Powerful research tools that speed up vaccine development have led to the
start
today of human tests for a preventive vaccine against the respiratory
disease
SARS. The disease killed hundreds of people around the world before it was
brought under control in 2003 with aggressive conventional public health
measures.

Researchers at the Vaccine Research Center, National Institute of Allergy
and
Infectious Diseases (NIAID), part of the National Institutes of Health
(NIH),
will conduct the trials. The experimental vaccine against SARS, or severe
acute
respiratory syndrome, will be tested on 10 healthy volunteers at the NIH
Clinical Center in Bethesda, MD. The clinic will do periodic follow-up exams
on
each volunteer for 32 weeks.

"This experimental vaccine is an outstanding achievement by NIAID
researchers,"
said Health and Human Services Secretary Tommy G. Thompson. "It is a model
for
research that could greatly shorten the time needed to create vaccines to be

tested against other diseases."

"The Vaccine Research Center, a cutting-edge facility established here at
NIH
just five years ago, encompasses the entire spectrum of vaccine development
from
basic research to clinical testing," says NIH Director Elias A. Zerhouni,
M.D.
"This is why our team at NIAID has been able to develop this vaccine at an
unprecedented pace, using technological discoveries that were not available
just
a few short years ago."

The primary goal of the study is to determine if the experimental vaccine is

safe in people. A secondary goal is to assess how well the vaccine
stimulates
the immune system to produce antibodies and cellular immunity, in this case,

focusing on the SARS spike protein. The spike protein protrudes from the
virus'
outer envelope and helps it bind to cells it infects.

SARS was brought under control with classic public health techniques:
epidemiological investigations, patient isolations, quarantines of exposed
people and stringent restrictions on travel. SARS was spotted first in China
in
November 2002. The virus sickened 8,096 and killed 774 worldwide by July
2003,
according to the World Health Organization (WHO).

The sudden appearance of SARS, its severity, and its ability to be spread
far
and fast by international travelers, spurred medical researchers. NIAID
researchers developed the vaccine with unprecedented speed. Just 21 months
passed from when international health officials recognized SARS as a new
infectious disease to the opening of the NIAID human clinical vaccine trial.
It
often takes decades for scientists to develop a successful vaccine against
an
infectious disease.

"In the case of SARS, we have dramatically cut vaccine development time with

powerful new tools from two different fields, molecular biology and
information
technology," says Anthony S. Fauci, M.D., director of NIAID.

Instead of using weakened or inactivated virus, which is typical for vaccine

development, the new vaccine is composed of a small circular piece of DNA
that
encodes the viral spike protein. Scientists modified the DNA to minimize the

risk of it combining with the SARS virus or other viruses of the SARS type,
called coronaviruses.

Scientists expect that the DNA will direct human cells to produce proteins
very
similar to the SARS spike protein. The immune system should recognize these
proteins as foreign and then mount a defense against them. If the vaccinated

person ever encounters the actual SARS virus, his or her immune system will
be
primed to neutralize it.

"It is truly remarkable that less than two years ago we were facing an
unknown
global health threat, and now we are testing a promising vaccine that may
help
us to counter that threat should it re-emerge," Dr. Fauci said.

After SARS was identified as a disease, researchers worked hastily to
identify
the cause of the mysterious respiratory ailment and to develop therapies and

vaccines. By April 2003, NIAID-funded researchers in Hong Kong were the
first to
show that SARS is a viral disease. They soon proved that a newly emerging
coronavirus causes SARS. By May, an international collaboration of
researchers
had decoded the genetic sequence of the SARS coronavirus, opening many
avenues
of research to develop diagnostic tests, therapies and vaccines.

An NIAID team, lead by NIAID Vaccine Research Center Director Gary J. Nabel,

M.D., used the available SARS coronavirus genomic information to develop a
vaccine based on the gene for the SARS spike protein. The vaccine performed
very
well in mice, reducing the levels of virus in the lungs of infected mice by
more
than a million-fold, Dr. Nabel and colleagues reported in "Nature" in March
2004.

"Two years ago, we didn't know that this virus existed. Today, we begin
clinical
trials of a promising vaccine candidate. We owe the speed of this research
to
modern molecular genetics. The technology enables us rapidly to translate
scientific discoveries into clinical interventions and improves our ability
to
battle these ever-evolving, highly lethal microbes," says Dr. Nabel.

Under a contract with NIAID, Vical Inc. of San Diego, CA, is producing the
SARS
vaccine for the NIAID clinical trial. For more information on the SARS
vaccine
trial, phone the Vaccine Research Center's toll free number 1-866 833-LIFE.

Chinese researchers began human testing of a SARS vaccine in May of this
year.
The Chinese vaccine trial uses an inactivated SARS virus vaccine developed
through conventional vaccine technology.

While the bulk of SARS cases were in China, Hong Kong and Singapore,
eventually
cases also occurred in Canada, Europe and the United States, according to
WHO.
There were 27 probable SARS cases in the United States. No U.S. residents
died
of the disease, according to WHO.

NIAID is a component of the National Institutes of Health, an agency of the
U.S.
Department of Health and Human Services. NIAID supports basic and applied
research to prevent, diagnose and treat infectious diseases such as HIV/AIDS
and
other sexually transmitted infections, influenza, tuberculosis, malaria and
illness from potential agents of bioterrorism. NIAID also supports research
on
transplantation and immune-related illnesses, including autoimmune
disorders,
asthma and allergies. News releases, fact sheets and other NIAID-related
materials are available on the NIAID Web site at <http://www.niaid.nih.gov>.


---------------------------
REFERENCE: Z Yang "et al". A DNA vaccine induces SARS coronavirus
neutralization
and protective immunity in mice. "Nature" 428:561-4 (2004). DOI:
10.1038/nature02463

##

This NIH News Release is available online at:
http://www.nih.gov/news/pr/dec2004/niaid-13.htm

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