Oct. 16, 2009
QUESTIONS AND ANSWERS
NIH Trial of 2009 H1N1 Influenza Vaccine in People with Asthma
- Why is it important to test 2009 H1N1 influenza vaccine in people with asthma?
Each year, the Centers for Disease Control and Prevention (CDC) recommends that people with asthma receive the seasonal influenza vaccine to prevent getting the flu, which may seriously worsen their asthma and increase their risk of severe influenza disease.
People with asthma are also at higher risk of complications following infection with 2009 H1N1 influenza virus. Review of hospital records by CDC from early in the disease outbreak in the United States found that although asthma occurs in about 8 percent of the U.S. population, 32 percent of people hospitalized due to 2009 H1N1 influenza had asthma.
U.S. public health officials, following the recommendation of the CDC’s Advisory Committee on Immunization Practices, have designated people with underlying medical conditions, including asthma, among the top priority groups to receive the 2009 H1N1 influenza vaccine.
This clinical trial of 2009 H1N1 influenza vaccine in people with asthma will provide information to public health officials to help answer questions including what dosage and how many doses of vaccine are needed to elicit immune responses indicative of protection against the 2009 H1N1 virus.
The clinical trial in people with asthma, like other trials of 2009 H1N1 influenza vaccines now being conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, will collect critically needed data. The trials are not intended to serve as a mechanism for mass immunization of the populations designated as high-priority groups to receive 2009 H1N1 influenza vaccine.
- Who is conducting the 2009 H1N1 influenza vaccine trial in people with asthma?
NIAID and the National Heart, Lung and Blood Institute (NHLBI), both part of the National Institutes of Health, are supporting this trial testing a 2009 H1N1 influenza vaccine in asthmatics. The trial is being conducted by the NHLBI Severe Asthma Research Program (SARP), a collaborative research program investigating the pathophysiology of severe asthma in adults and children and how it differs from mild to moderate asthma.
- When did the trial begin?
Study participants received the first dose of 2009 H1N1 influenza vaccine starting on Oct. 16, 2009.
- What is the design of the 2009 H1N1 influenza vaccine trial in people with asthma?
The study will enroll approximately 350 adolescents and adults ages 12 years and older with mild, moderate or severe asthma. Participants will be categorized by asthma severity into two groups (mild/moderate and severe); by age into three groups (12 to 17 years old, 18 to 64 years old and older than 64); and by study site. They will be randomly assigned, within each asthma category, to receive a low or high dosage of the inactivated 2009 H1N1 influenza vaccine. The trial is open-label, meaning the clinicians and participants will know the dosage of vaccine administered.
All participants will receive two injections of the vaccine spaced three weeks apart. Approximately 100 individuals with mild or moderate asthma and 75 individuals with severe asthma will receive 15-microgram doses of the vaccine. Approximately 100 individuals with mild or moderate asthma and 75 individuals with severe asthma will receive 30-microgram doses of the vaccine. The 30-microgram dose of the vaccine will be administered as two 15-microgram injections, one in each arm or thigh.
A total of five clinic visits will be required during the study period. Vaccine injections will be administered on Days 1 and 21 of the study. During visits, blood samples will be taken and lung function will be assessed. In addition, participants will complete a self-evaluation questionnaire about their asthma.
All participants will be provided with a diary on Day 1 to track their asthma symptoms and record the number of times they take asthma medications during the study period. Diary entries will be reviewed by study investigators at each of the five clinic visits. Follow-up telephone calls to track participants’ health status will be conducted for 6 months after the second dose of the vaccine is given.
The major goal of the study is to determine if people with asthma who take high doses of glucocorticoids require one or two doses of the standard vaccine (15 micrograms), or whether they need a higher dose (30 micrograms). Study investigators will look for indications of immune system responses, such as the production of antibodies against 2009 H1N1 influenza virus. Blood samples will be drawn at set time points following the first and second injections to provide information about the immune response to the vaccine. The safety of the vaccine in people with asthma also will be assessed.
A detailed description of the study can be found on the ClinicalTrials.gov Web site.
- Who is eligible to participate in the study?
The trial will enroll approximately 350 males and non-pregnant females age 12 years and older with mild to moderate or severe asthma.
The study population will primarily be drawn from individuals with asthma who are already participating in a SARP study. Additional participants may be recruited, but only if they are known to a SARP investigator and their asthma can be characterized based on SARP definitions.
SARP participants have been extensively characterized with respect to their asthma severity, lung function and airway inflammation. These groups are largely distinguished by the amount and frequency of glucocorticoids needed to control their 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.
- Where will the study take place?
The seven study sites include Cleveland Clinic Foundation, Ohio; Emory University, Atlanta; University of Pittsburgh Asthma Institute; University of Virginia, Charlottesville; University of Wisconsin, Madison; Wake Forest University, Winston-Salem, N.C.; and Washington University, St. Louis. Each site will enroll approximately 50 study participants.
- What is the vaccine being tested in this trial?
The trial is testing a 2009 H1N1 influenza vaccine produced by Novartis Vaccines and Diagnostics Ltd. in its facility in Speke, Liverpool, United Kingdom. The vaccine is made from an inactivated 2009 H1N1 flu virus and does not contain an adjuvant, a substance added to a vaccine to enhance the immune response.
During the production of the vaccine, thimerosal, a chemical that prevents bacterial contamination, is required. This chemical is removed in the preparation of the single-dose syringes containing the vaccine, which will be used in this clinical trial. The only known side effects of receiving trace amounts of thimerosal in vaccines have been minor reactions such as redness and swelling at the injection site. More information on the use of thimerosal in vaccines can be found on the CDC Web site.
- How does the 2009 H1N1 influenza vaccine being tested in this trial compare with the regular seasonal flu vaccine?
The candidate 2009 H1N1 flu vaccine being tested in this clinical trial is very similar to the annual influenza vaccine recommended by CDC for all asthmatics. The vaccine is produced in the same way as most seasonal flu vaccines—virus is grown in fertilized chicken eggs, then the virus is inactivated and used to make the vaccine.
- How is safety being monitored in the trial?
Safety is being closely monitored throughout the trial, both by the study investigators and by an independent panel of experts known as a Data and Safety Monitoring Board. This board is convened by NIAID to review the data from this NIAID-sponsored 2009 H1N1 influenza candidate vaccine trial in people with asthma. The committee has regularly scheduled meetings during the course of the trial and also is available for ad hoc meetings as needed.
- How long with the trial last?
The study will last approximately 7 months, including clinic visits for the first three weeks and follow-up phone calls over a six-month period.
- When will the results from the trial become available?
Results will be available when all the blood samples have been analyzed, which is expected to take a few months.
- Where can I get more information on other NIH-sponsored clinical trials of 2009 H1N1 influenza vaccines?
For more information about other NIAID-sponsored clinical trials of 2009 H1N1 flu vaccines, see the following Questions and Answers documents:
- Where can I get additional information on influenza and asthma?
Visit the CDC Web site for information for the general public and for healthcare providers about seasonal influenza and asthma, 2009 H1N1 influenza in people with asthma, avian and pandemic influenza, and asthma.
Media inquiries can be directed to the NIAID News and Public Information Branch at 301-402-1663, niaidnews@niaid.nih.gov.
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 http://www.nih.gov.
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