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, September 21, 2009

MEDIA CONTACT: NIAID Office of Communications, 301-402-1663,
<niaidnews@niaid.nih.gov>

EARLY RESULTS: IN CHILDREN, 2009 H1N1 INFLUENZA VACCINE WORKS LIKE SEASONAL FLU
VACCINE

Early results from a trial testing a 2009 H1N1 influenza vaccine in children
look promising, according to the trial sponsor, the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National Institutes of
Health. Preliminary analysis of blood samples from a small group of trial
participants shows that a single 15-microgram dose of a non-adjuvanted 2009 H1N1
influenza vaccine - the same dose that is in the seasonal flu vaccine -
generates an immune response that is expected to be protective against 2009 H1N1
influenza virus in the majority of 10- to 17- year-olds eight to 10 days
following vaccination. These results are similar to those recently reported in
clinical trials of healthy adults. Younger children generally had a less robust
early response to the vaccine. 

"This is very encouraging news," says NIAID Director Anthony S. Fauci, M.D."  As
we had hoped, responses to the 2009 H1N1 influenza vaccine are very similar to
what we see with routinely used seasonal influenza vaccines made in the same
way. It seems likely that the H1N1 flu vaccine will require just one
15-microgram dose for children 10 to 17 years of age. The 2009 H1N1 influenza
virus is causing widespread infections among children, so these are welcome
results."

The ongoing NIAID-sponsored trial began in mid-August at five sites nationwide.
The trial is assessing the safety and immune responses to one and two doses of
either 15 micrograms or 30 micrograms of vaccine. Data from the trial is being
compared for three age groups: children 6 months to 35 months old; 3 to 9 years
old; and 10 to 17 years old. 

The preliminary results are based on blood samples taken eight to 10 days after
the first vaccination. Immune responses were strongest among the oldest
children, those 10 to 17 years old. In this group of 25 children, a strong
immune response was seen in 76 percent who received one 15-microgram dose of
vaccine. The immune responses in children nine years old and younger were not as
strong. Among 25 volunteers aged 3 to 9 years old, a strong immune response was
seen in 36 percent of those given 15 micrograms of vaccine. In the youngest
group, 20 children between 6 months to 35 months old, a single 15-microgram dose
of vaccine produced a strong immune response in 25 percent of recipients.

"These results are not unexpected and are both similar to what is seen with
seasonal influenza vaccines and consistent with what we and our colleagues at
the Food and Drug Administration anticipated," notes Dr. Fauci.

Study investigators are also collecting blood samples from the volunteers
approximately three weeks after both the first and second injections. It is
anticipated that the immune response to the 2009 H1N1 influenza vaccine will be
similar to that of seasonal influenza vaccination and will continue to rise for
several weeks following vaccination, says Dr. Fauci. The study is being closely
monitored by the trial physicians and staff as well as by an independent safety
monitoring committee.

The vaccine being tested in this trial is manufactured by Sanofi Pasteur in
Swiftwater, Pa., in the same manner as its licensed seasonal vaccine, which is
used every year in millions of children, and is the same formulation recently
licensed by the FDA to protect against 2009 H1N1 influenza. Like inactivated
seasonal influenza vaccines, the vaccine contains a purified part of a killed
virus and cannot cause flu. 

NIAID is conducting trials of 2009 H1N1 influenza vaccines through its
longstanding vaccine clinical trials network, the Vaccine and Treatment
Evaluation Units. Additional information about the NIAID-sponsored clinical
trials in children is available in an Aug. 18 Bulletin: <http://www3.niaid.nih.gov/news/newsreleases/2009/H1N1pedvax.htm>
and a Q&A: <http://www3.niaid.nih.gov/news/QA/qaH1N1pedvax.htm>. A detailed
description of the trial protocol is at clinicaltrials.gov: <http://clinicaltrials.gov/show/NCT00944073>.

For more information on influenza, including pandemic influenza and avian
influenza, visit www.flu.gov. Also, see NIAID's 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 <www.nih.gov>.

##

This NIH News Release is available online at:
<http://www.nih.gov/news/health/sep2009/niaid-21.htm>.

To subscribe (or unsubscribe) from this list, go to
<http://list.nih.gov/cgi-bin/wa?SUBED1=nihpress&A=1>.