- ATLANTA -- Physician/researchers
at Emory University and Children's Healthcare of Atlanta have begun vaccinating
children in a clinical trial testing an investigational H1N1 (swine flu)
vaccine along with the seasonal flu vaccine. Up to 650 children nationally
will participate in the study, and Emory will enroll approximately 100
children, ages six months to 18 years.
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- The clinical trial is being conducted within the Vaccine
and Treatment Evaluation Units (VTEUs), supported by the National Institute
of Allergy and Infectious Diseases (NIAID) of the National Institutes of
Health (NIH). At Emory, the VTEU is led by Mark Mulligan, MD, executive
director of the Hope Clinic of the Emory Vaccine Center.
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- The study will examine the safety of and measure the
body's immune response to the H1N1 flu vaccine. In addition, it will help
determine how and when the vaccine should be given with the seasonal flu
vaccine to make it most effective. It also will analyze potential problems
of giving the vaccines together, such as whether one vaccine will undermine
the protective power of the other.
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- The answer is important because experts are predicting
that both strains of influenza will circulate this fall and winter.
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- The Centers for Disease Control and Prevention's (CDC)
Advisory Committee on Immunization Practices (ACIP) recently recommended
all people from six months through 24 years of age receive the H1N1 influenza
vaccine when it is available. In making its recommendations, the group
considered current disease patterns and current trends that showed populations
most at risk of serious illness, among other factors.
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- The panel recommended vaccinating children between six
months and 18 years because of the high number of cases of H1N1 influenza
infection in that age group. In addition, because they frequently are in
school and day care, they are in close contact with each other, making
it easier to spread disease.
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- The Emory pediatric clinical trial will be conducted
at the Emory-Children's Center. The trial is being led by Emory VTEU co-directors
Harry Keyserling, MD, professor of pediatric infectious diseases at Emory
School of Medicine and Paul Spearman, MD, chief research officer for Children's
Healthcare of Atlanta and vice chair of research for Emory's Department
of Pediatrics, along with Allison Ross, MD, Emory assistant professor of
pediatric infectious diseases.
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- The pediatric trial follows the launch of a VTEU-led
adult clinical trial of the H1N1 and seasonal flu vaccines, which began
at Emory's Hope Clinic on Aug. 10 and will continue with followup visits
for the next six weeks by a group of more than 170 volunteers.
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- "Because children and young adults are considered
among the most vulnerable populations for new and emerging strains of influenza,
such as the current H1N1 pandemic, it is critically important that we quickly
and efficiently conduct these tests for a vaccine," says Keyserling,
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- In addition to Emory, other sites for the H1N1 pediatric
study, which is led by Saint Louis University, are Baylor College of Medicine,
Houston; Children's Hospital Medical Center in Cincinnati; University of
Texas Medical Branch at Galveston; and the University of Iowa.
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- The VTEUs were established in 1962 as a vital research
component of the NIAID. The units conduct clinical trials for all infectious
diseases other than HIV/AIDS. They have conducted hundreds of clinical
studies over the past four decades. Emory was designated a VTEU site in
2007 and received a seven-year contract of approximately $23.7 million.
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- An important strength of the VTEUs is their ability to
rapidly enroll large numbers of volunteers into trials and to immunize
the volunteers in a safe, effective and efficient manner. This rapid-response
capability is especially important for testing vaccines designed to combat
pandemic influenza. Results are expected to be available weeks after the
trials begin.
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- For more information on this clinical study visit <http://clinicaltrials.gov/show/NCT00943202>http://clinicaltrials.gov/show/NCT00943202.
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- For more information about the Emory pediatric clinical
trial, call 404-727-4044.
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- Media Contact: Holly Korschun, <mailto:hkorsch@emory.edu>hkorsch@emory.edu,
404-727-3990
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- The Robert W. Woodruff Health Sciences Center of Emory
University is an academic health science and service center focused on
missions of teaching, research, health care and public service. Its components
include the Emory University School of Medicine, Nell Hodgson Woodruff
School of Nursing, and Rollins School of Public Health; Yerkes National
Primate Research Center; Emory Winship Cancer Institute; and Emory Healthcare,
the largest, most comprehensive health system in Georgia. Emory Healthcare
includes: The Emory Clinic, Emory-Children's Center, Emory University Hospital,
Emory University Hospital Midtown, Wesley Woods Center, Emory University
Orthopaedics & Spine Hospital, the jointly owned Emory-Adventist Hospital,
and EHCA, a limited liability company created with Hospital Corporation
of America. EHCA includes two joint venture hospitals, Emory Eastside Medical
Center and Emory Johns Creek Hospital. The Woodruff Health Sciences Center
has a $2.3 billion budget, 18,000 employees, 2,500 full-time and 1,500
affiliated faculty, 4,300 students and trainees, and a $5.5 billion economic
impact on metro Atlanta.
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