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MEDICAL: DISEASES: INFLUENZA:
Initial Results Show Pregnant Women Mount Strong Immune Response
to One Dose of 2009 H1N1 Flu Vaccine
Date: Mon, 2 Nov 2009 13:03:30 -0500
From: "NIH OLIB (NIH/OD)" <[log in to unmask]>
To: [log in to unmask]
Subject: Initial Results Show Pregnant Women
Mount Strong Immune Response to One Dose of 2009 H1N1 Flu Vaccine
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: Monday, November 2, 2009
MEDIA CONTACT:
NIAID Office of Communications
301-402-1663,
e-mail:
[log in to unmask]
INITIAL RESULTS SHOW PREGNANT WOMEN MOUNT
STRONG IMMUNE RESPONSE TO ONE DOSE OF 2009 H1N1 FLU VACCINE
Healthy pregnant women mount a robust immune response following just one
dose of 2009 H1N1 influenza vaccine, according to initial results from an
ongoing clinical trial sponsored by the National Institute of Allergy and
Infectious Diseases (NIAID) of the National Institutes of Health.
"For pregnant women, who are among the most vulnerable to serious health
problems from 2009 H1N1 infection, these initial results are very
reassuring," says NIAID Director Anthony S. Fauci, M.D. "The immune
responses seen in these healthy pregnant women are comparable to those
seen in healthy adults at the same time point after a single vaccination,
and the vaccine has been well tolerated."
According to the Centers for Disease Control and Prevention, since the
outbreak began last spring, at least 100 pregnant women have been
hospitalized in intensive care units in the United States and at the last
official count, 28 pregnant women have died.
A preliminary analysis of blood samples taken 21 days post-vaccination
from a subgroup of 50 pregnant women participating in the trial shows the
following:
-- In 25 women who received a single 15-microgram dose of the vaccine, the
H1N1 flu vaccine elicited an immune response likely to be protective in 92
percent, or 23 of 25, of these women.
-- In 25 women who received a single 30-microgram dose of the vaccine, the
H1N1 flu vaccine elicited an immune response likely to be protective in 96
percent, or 24 of 25, of these women.
The trial began on Sept. 9 and reached its target enrollment of 120
volunteers in mid-October. All participants are between 18 to 39 years
old and began the study in their second or third trimester (14 to 34
weeks) of pregnancy.
At entry into the study, the participants were divided at random into two
groups: half are receiving two doses of a 15-microgram vaccine and the
other half are receiving two doses of a 30-microgram vaccine. The two
injections of vaccine are spaced three weeks apart.
Safety is being monitored closely in the trial, by the study investigators
and by an independent panel of experts known as a safety monitoring
committee. To date, the vaccine appears to be well-tolerated, and no
safety concerns related to the vaccine have arisen.
The vaccine used in this clinical trial was manufactured by Sanofi Pasteur
in its plant in Swiftwater, Pa., in the same manner as the company's
injectable seasonal influenza vaccine. Like the seasonal flu vaccine, the
2009 H1N1 flu vaccine contains a purified portion of the killed virus and
therefore cannot cause infection. The vaccine does not contain the
preservative thimerosal or an immune boosting substance known as an
adjuvant.
NIAID is conducting this trial through five clinical sites affiliated with
its longstanding clinical trials network known as the Vaccine and
Treatment Evaluation Units. For additional information about the NIAID
trial in healthy pregnant women, see the Sept. 9 NIAID news release
<http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pregnanttrials.htm>
and related Q&A
<http://www3.niaid.nih.gov/news/QA/H1N1pregnanttrials.htm>
For more information on influenza, including pandemic influenza and avian
influenza, visit <www.flu.gov>. Also see NIAID's influenza Web portal at
<http://www3.niaid.nih.gov/topics/Flu/>
NIAID conducts and supports research - at NIH, throughout the United
States, and worldwide - to study the causes of infectious and
immune-mediated diseases, and to develop better means of preventing,
diagnosing and treating these illnesses. News releases, fact sheets and
other NIAID-related materials are available on the NIAID Web site at
<http://www.niaid.nih.gov>
The National Institutes of Health (NIH) -- The Nation's Medical Research
Agency -- includes 27 Institutes and Centers and is a component of the
U.S. Department of Health and Human Services. It is the primary federal
agency for conducting and supporting basic, clinical and translational
medical research, and it investigates the causes, treatments, and cures
for both common and rare diseases. For more information about NIH and its
programs, visit
<http://www.nih.gov>
##
This NIH News Release is available online at:
<http://www.nih.gov/news/health/nov2009/niaid-02.htm>
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David Dillard
Temple University
(215) 204 - 4584
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