News Release: Emory Healthcare , Research
Nov. 5, 2009
H1N1 Clinical Trial Tests Vaccine in Asthma Patients at Emory, Children's Healthcare of Atlanta
The Emory-Children's Center is participating in a national clinical trial to determine the best dose of H1N1 vaccine for people with asthma, especially those with severe disease. The study is sponsored by the National Institute of Allergy and Infectious Diseases through a collaboration with the National Heart, Lung, and Blood Institute (NHLBI), both components of the National Institutes of Health.
The trial is being conducted at Emory and six other sites that participate in NHLBI's Severe Asthma Research Program (SARP). About 350 adolescents and adults ages 12 years and older with mild, moderate and severe asthma will be enrolled in the overall national clinical trial.
Participants in the study at the Emory-Children's Center, which is jointly run by Emory and Children's Healthcare of Atlanta, will be selected from people already enrolled in the existing SARP asthma research program. At Emory, the SARP program works with a large group of children, with the goal of understanding the causes of severe childhood asthma.
People with severe asthma are at greater risk for complications following flu infection. They also often take high doses of glucocorticoid medications that can suppress their immune systems, putting them at even greater risk for infection and serious disease.
Each year the Centers for Disease Control and Prevention (CDC) recommends that people with asthma receive the seasonal flu vaccine. This year people with underlying medical conditions, including asthma, are among the top priority groups to receive the H1N1 vaccine. A CDC study of the H1N1 outbreak early in 2009 found that people with asthma had a four-fold increased risk of hospitalization after infection compared to the general population.
"We need to find out the optimal dose of H1N1 flu vaccine that can be safely given to our asthma patients, and whether one or two doses are needed to produce a protective immune response," says Anne Fitzpatrick, PhD, principal investigator of the Emory trial.
Fitzpatrick leads the SARP program at the Emory-Children's Center. Program participants include those with mild, moderate or severe asthma. People with mild disease may take lower doses of inhaled glucocorticoids, while those with more severe disease may take higher doses of both inhaled and oral medication.
Early results from clinical trials of H1N1 vaccine in healthy adults and children ages 10 and older have shown that a single dose of vaccine is adequate to induce a protective immune response. The clinical trial will try to determine which dose is adequate for asthma patients.
Participants in the clinical trial 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. Participants also will be organized into three age groups (12 to 17; 18 to 64; and older than 64).
The strength of the immune response will be tested by measuring the level of antibodies against the H1N1 virus in blood samples. Safety data will be collected throughout the trial and examined by investigators and an independent safety monitoring board.
The vaccine used in the trial, manufactured by Novartis, contains inactivated 2009 H1N1 influenza virus and therefore cannot cause anyone to become infected with the virus.
For questions and answers about the study on the NIH web site, see: http://www3.niaid.nih.gov/news/QA/H1N1VacASTHMAqa.htm
For detailed information about the study on the ClinicalTrials.gov web site, see: http://clinicaltrials.gov/ct2/show/NCT00978120?term=H1N1+asthma&rank=1
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