Pitt and UPMC to test H1N1 vaccinations on people with asthma

Pitt and UPMC researchers will test whether people with asthma can benefit from multiple shots… Pitt and UPMC researchers will test whether people with asthma can benefit from multiple shots of the H1N1 virus vaccine, which so far hasn’t worked for them.

Initial tests have shown that the H1N1 vaccine has worked well for the general population, Sally Wenzel, director of the University of Pittsburgh Asthma Institute at UPMC, said.

But Wenzel, who is involved with the study because of her expertise on asthma, said inhaled and oral steroids that people take to control asthma can interfere with the vaccine, putting people with asthma at high risk for contracting the H1N1 virus.

“We don’t know specifically how they interfere,” Wenzel said. “It is speculation. We know that steroids are anti-inflammatories, which suppress the production of the body’s antibodies. Asthmatic H1N1 patients experienced pneumonia, infections and, in some cases, death — and all because of their asthma medications.”

Eight physicians from Children’s Hospital, UPMC and other area hospitals will begin administering the vaccine to asthma patients next Friday. Patients will receive two vaccines in the arm administered three weeks apart. For nine months, they will talk regularly with their doctors, either in person or over the phone.

Researchers will evaluate the amount of H1N1 antibody that asthmatics receiving the vaccine build up in their blood. They will also evaluate lung function in the asthma patients before the first vaccine and in later visits. Patients will undergo blood tests every one to two weeks for the first six weeks of the trial, at which point researchers will know how many antibodies their bodies produced.

“We just don’t know if the vaccine will be effective in asthmatics,” Wenzel said, “but the two shots should work.”

Wenzel said researchers don’t yet know why it’s possible that two shots could work when one does not, but they hope this study will provide an answer.

She said researchers selected 500 people to participate in the test based on the severity of their asthma, but only 70 chose to participate.

“It was a matter of will,” Wenzel said. “Someone may not want to go through the process of the study, but eventually, everyone will be eligible to get the vaccination.”

The H1N1 vaccine is approved by the Food and Drug Administration, and some places have already begun distributing it.

“People have started to be vaccinated in high-risk areas,” Wenzel said. “Health care workers and caregivers have been among those first in line.”

Wenzel could not specify where the vaccines were distributed. According to the Centers for Disease Control and Prevention website, the National Institutes of Health and manufacturers under contract with the U.S. Department of Health and Human Services began clinical trials around the country.

The study compares responses to the vaccination in patients with mild to moderate asthma and in patients with severe asthma. Pittsburgh’s heavy involvement with asthma research has led to its participation in the nationwide study, funded by the National Institutes of Health.

“Pittsburgh and UPMC is actively involved in studying asthmatics and understanding asthma, especially severe asthma,” Wenzel said.

The vaccine costs $25 wholesale. Wenzel said she’s not sure how much of the cost of the vaccine will be covered by health insurance providers.

Other participating institutes include Washington University in St. Louis, Wake Forest University, the University of Wisconsin, the Cleveland Clinic, the University of Virginia and Emory University.