The Emory-Children’s Center is conducting clinical trials to find the optimal dosage of the H1N1 vaccine to administer to asthma patients, a condition that has placed them at a higher risk of developing complications and could exacerbate their asthma symptoms.

Emory is one of six universities participating in this national study sponsored by the National Institute of Allergy and Infectious Diseases and the National Heart, Lung and Blood Institute (NHLBI), both of which are part of the National Institutes of Health.

The trials began in mid-October and are set to end in December immediately before winter break, according to Anne Fitzpatrick, the principal investigator for the Emory trials.

Other universities participating in the trials include University of Virginia, University of Pittsburgh and Washington University in St. Louis.

All six universities taking part in the study are involved in the NHLBI’s Severe Asthma Research Program (SARP).

At Emory, about 30 patients are participating in the trial and, from the six universities combined, about 350 are involved with the study.

Those who are participating in the trials are people with mild, moderate or severe asthma who are at least 12 years old and are involved with SARP.

Fitzpatrick said the study is meant to examine asthma patients’ immune response to the H1N1 vaccine to determine the best doses to give these patients.

The fact that asthma medication contains glucocorticoids, a type of steroids, may impact the dosage of the H1N1 vaccine that asthma patients must receive, she added.

“The concern is patients treated with higher doses of steroids may need higher doses of the vaccine or a booster,” Fitzpatrick said.

A booster is a second dose of the vaccine meant to increase the immune system’s response to the first dose of the vaccine.

About 30 percent of people hospitalized due to the H1N1 virus have asthma, Fitzpatrick said.

“Asthma patients already have difficulty breathing,” Fitzpatrick said. “So, when they catch influenza, which is a respiratory virus, on top of asthma, this causes further inflammation of their airways.”

Executive Director of Student Health Services Michael Huey said the lungs are the “primary attack point” for influenza illnesses, including the H1N1 virus.
He explained people with asthma have trouble fighting off illnesses like various types of influenza that further affect their lungs.

“Anyone with an underlying pulmonary condition is going to be at increased risk for complications due to influenza whether it is the H1N1 virus or seasonal influenza,” Huey said.

Also, because those with asthma are amongst members of the priority group the Centers for Disease Control and Prevention has designated to receive the H1N1 vaccine first, Fitzpatrick said it is very important to determine the correct dosage for people with asthma.

During the clinical trials, participants will be divided into two groups based on whether they have moderate or severe asthma, according to a University press release published Nov. 5.

“The more severe the asthma, the greater the risk,” Huey said.

Half of the members of each group will receive a 15-microgram dose of the H1N1 vaccine and the other halves will receive a 30-microgram dose, but no one will know how much of the vaccine they are getting, Fitzpatrick said.

Participants will also be organized into three age groups: 12 to 17, 18 to 64, and older than 64, according to the press release.

Twenty-one days after the first dose is administered, each participant will receive a second dose of the same amount they first received, Fitzpatrick said.

To monitor the effects of the varying doses of the H1N1 vaccine, doctors will administer breathing tests, draw blood from the patients and ask them questions about how their asthma has been impacted by the vaccine.

Patients must also fill out diary cards outlining their asthma symptoms throughout the trial.

“At the end of the day we will be able to see what the right dose is and if we need a booster,” Fitzpatrick said.

The Emory-Children’s Center will continue to monitor the participants in the clinical trials for six months following the end of the trial in December, Fitzpatrick said.

Other similar clinical trials at universities are focusing on pregnant women, children and other members of the CDC’s priority group.

“We definitely encourage people to get the H1N1 vaccine,” Fitzpatrick said.

— Contact Molly Davis.