WINSTON-SALEM, N.C. – An important H1N1 vaccine study that will look at the high risk population group of asthmatics will be conducted by the Center for Genomics and Personalized Medicine Research at Wake Forest University School of Medicine as part of the first government-sponsored clinical trial launched by the National Institutes of Health.
The purpose of the study – which is co-sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Heart, Lung, and Blood Institute (NHLBI), both part of NIH – is to determine the safety of the 2009 H1N1 influenza vaccine in people with asthma and the dose needed to induce a protective immune response in these patients, especially those with severe asthma. The clinical trial will be conducted at seven sites across the United States that currently participate in NHLBI’s Severe Asthma Research Program, including Wake Forest. The study starts today.
The other participating sites are: Cleveland Clinic, Emory University, University of Pittsburgh Asthma Institute, University of Virginia, University of Wisconsin and Washington University School of Medicine (St. Louis).
“This is an extremely important study sponsored by the NIH that will determine how we can safely and effectively immunize asthmatics for H1N1 influenza, since asthmatics are at a high risk for developing more severe H1N1 infections,” said Eugene R. Bleecker, M.D., professor of medicine and director of the Center for Genomics and Personalized Medicine Research at Wake Forest University School of Medicine.
The NIH has supported basic influenza research to better understand how influenza viruses replicate, interact with their hosts, stimulate and evade immune responses, and evolve into new strains. Results from these studies are used to design new therapies, diagnostics and vaccines.
The Severe Asthma Research Program already has a well-characterized group of participants with mild, moderate and severe asthma who may be eligible for this study. These groups are largely distinguished by the amount and frequency of corticosteroids needed to control asthma symptoms, ranging from those with very mild asthma who do not require corticosteroids to patients with severe asthma who need high doses of inhaled corticosteroids and frequently oral corticosteroids as well.
People who have asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who required high doses of corticosteroids to treat their asthma may receive less protection from influenza vaccines and therefore may require higher doses of these vaccines. 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.
“We are very excited. This is a good study for us,” said Wendy C. Moore, M.D., associate professor of internal medicine - pulmonary at Wake Forest University School of Medicine. “It gives us the opportunity to offer this important vaccine to our research participants while investigating the best way to give the vaccine to asthma patients in the general population.”
The randomized study will look at two different doses of vaccine and compare mild-moderate asthma to severe asthma. The Center for Genomics and Personalized Medicine Research will involve 100 to 150 patients who are already participating in the Severe Asthma Research Program. 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.
“As a result of this study, the NIH will be able to advise asthma patients as to the safety of the new vaccine as well as determine the dose of vaccine they need to be protected from H1N1” said Moore. “There is a lot of misinformation about the seasonal flu vaccine and how it affects asthmatics, and, as a result, vaccination rates for this population group are terrible.”
The Center for Genomics and Personalized Medicine Research was established in June 2000 as the Center for Human Genomics, a multimillion dollar research initiative to identify genes that contribute to common human diseases and determine how these genes interact with environmental risk factors. The center also facilitates the development of novel therapeutic regimes and investigates interactions between genes and therapeutic responses to drug therapy. The center’s research priorities include pulmonary disease, cardiovascular disease, diabetes and prostate cancer.
Detailed information about this study can be found on the ClinicalTrials.gov web site
For more information about NIAID-sponsored clinical trials in asthmatics, click here.
Additional information about NIAID-sponsored clinical trials of candidate H1N1 vaccines can be found here: Clinical Trials of 2009 H1N1 Influenza Vaccines Conducted by the NIAID-Supported Vaccine and Treatment Evaluation Units.
Visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza.
Also, visit NIAID’s Web sites for more information about flu and asthma and NHLBI’s Web site for more information about asthma.
For additional information about the NHLBI’s Severe Asthma Research Program, contact the NHLBI Office of Communications at (301) 496-4236 or e-mail nhlbi_news@nhlbi.nih.gov
Media Relations
Bonnie Davis: bdavis@wakehealth.edu, 336-713-1597
Mark Wright: news@wakehealth.edu, 336-713-4587