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NIH
Prepares to Launch 2009 H1N1 Influenza
Vaccine Trial in People with Asthma
The
National Institutes of Health is preparing to launch
the first government-sponsored clinical trial to determine
what dose of the 2009 H1N1 influenza vaccine is needed
to induce a protective immune response in people with
asthma, especially those with severe disease. The
study is cosponsored by the National Institute of
Allergy and Infectious Diseases (NIAID) and the National
Heart, Lung, and Blood Institute (NHLBI), both part
of NIH.
"People
with severe asthma often take high doses of glucocorticoids
that can suppress their immune system, placing them
at greater risk for infection and possibly serious
disease caused by 2009 H1N1 influenza virus,"
says NIAID Director Anthony S. Fauci, M.D. "We
need to determine the optimal dose of 2009 H1N1 influenza
vaccine that can be safely administered to this at-risk
population and whether one or two doses are needed
to produce an immune response that is predictive of
protection."
The
study plan has been submitted to the Food and Drug
Administration for review. With FDA allowing it to
proceed, the clinical trial will be conducted at seven
sites across the United States that participate in
NHLBI's Severe Asthma Research Program.
This
program already has a well-characterized group of
participants with mild, moderate or severe asthma
who may be eligible for this new study. These groups
are largely distinguished by the amount and frequency
of glucocorticoids needed to control asthma symptoms.
People with mild disease may not need glucocorticoids,
or may require low doses of inhaled glucocorticoids;
those with moderate asthma need low to moderate doses
of inhaled glucocorticoids; and those with severe
asthma need high doses of inhaled glucocorticoids
and frequently use oral glucocorticoids as well.
Individuals
who already have been infected with 2009 H1N1 influenza
or have received a 2009 H1N1 influenza vaccination
will not be eligible for the study.
"The
results of this study will have immediate implications
for individuals with severe asthma as well as those
who have milder asthma," says NHLBI Director
Elizabeth G. Nabel, M.D.
Early
results from other clinical trials of 2009 H1N1 influenza
vaccines in healthy adults have shown that a single
15-microgram dose of 2009 H1N1 influenza vaccine without
adjuvant is well tolerated and induces a strong immune
response in most participants. The same vaccine also
generates an immune response that is expected to be
protective in healthy children ages 10 to 17 years.
Ongoing trials are comparing the immune response to
one and two doses of 15- or 30-micrograms of vaccine
given three weeks apart in various populations.
The
Centers for Disease Control and Prevention has recommended
that certain at-risk populations receive the new H1N1
vaccine as a priority before the general population.
These target populations include pregnant women, health
care providers and individuals with underlying chronic
medical conditions, including asthma.
People
who have severe asthma may be particularly at risk
for infection with the 2009 H1N1 influenza virus.
A report published in 2004 suggested that some people
who took high doses of glucocorticoids to treat their
asthma may receive less protection from influenza
vaccines against some strains of influenza. Early
in the 2009 H1N1 flu outbreak a CDC review of hospital
records found that people with asthma have a four-fold
increased risk of being hospitalized with infection
compared to the general population.
The
study will enroll approximately 350 people with mild,
moderate and severe asthma. Participants will be organized
into two groups: those with mild or moderate asthma
and those with severe asthma. Half of the participants
in each group will receive a 15-microgram dose of
vaccine, and the other half a 30-microgram dose. Three
weeks later, each participant will receive a second
dose of the same amount. The strength of the immune
response induced by the vaccine will be determined
in blood samples by measuring the level of antibodies
against 2009 H1N1 flu virus.
Safety
data will be collected and examined throughout the
course of the study by trial investigators and by
an independent safety monitoring committee. Participants
will be monitored for any side effects they may experience
because of the vaccine, as well as asthma attacks
that occur during the study period.
The
vaccine to be used in the trial, manufactured by Novartis,
contains inactivated 2009 H1N1 influenza virus and
therefore cannot cause anyone to become infected with
the virus.
The trial will be conducted at the following locations:
-
Cleveland Clinic, Ohio
- Emory University, Atlanta
- University of Pittsburgh Asthma Institute
- University of Virginia, Charlottesville
- University of Wisconsin, Madison
- Wake Forest University, Winston-Salem, N.C.
- Washington University School of Medicine, St.
Louis
Detailed
information about this study can be found on the ClinicalTrials.gov
Web site at http://clinicaltrials.gov/ct2/results?term=H1N1+AND+asthma.
For additional information about NIAID-sponsored clinical
trials of candidate H1N1 vaccines:
Visit
www.flu.gov
for one-stop access to U.S. government information
on avian and pandemic influenza and www.aids.gov for
comprehensive U.S. government information about HIV/AIDS.
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 www.niaid.nih.gov.
The
NICHD sponsors research on development, before and
after birth; maternal, child, and family health; reproductive
biology and population issues; and medical rehabilitation.
For more information, visit the Institute's Web site
at www.nichd.nih.gov.
Part
of the National Institutes of Health, the National
Heart, Lung, and Blood Institute (NHLBI) plans, conducts,
and supports research related to the causes, prevention,
diagnosis, and treatment of heart, blood vessel, lung,
and blood diseases; and sleep disorders. The Institute
also administers national health education campaigns
on women and heart disease, healthy weight for children,
and other topics. NHLBI press releases and other materials
are available online at www.nhlbi.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.
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Public
health agencies in the U.S. and around the world began immunizing
people against H1N1 influenza earlier this month. The vaccines
now in use are based on the same technology as the annual
seasonal flu vaccine, and are expected to be generally well
tolerated. In an effort to stem a rapidly spreading epidemic,
however, the new vaccines were ushered rapidly through the
development process without extensive testing in diverse
populations, leading to some concerns about their safety.
