July 24, 2009 Bracing for an outbreak of 2009 H1N1 (swine-origin) flu that a Saint Louis University infectious diseases expert estimates could sicken one in five people this fall, scientists at eight Vaccine and Treatment Evaluation Units funded by the National Institutes of Health (NIH) are launching a series of clinical trials this summer to test vaccines to protect against the illness.
“Efforts to find an effective vaccine against H1N1 influenza are historic,” said Sharon Frey, M.D., professor of infectious diseases at Saint Louis University School of Medicine and lead investigator for one of the national research studies.
“Scientists very quickly identified the flu virus, industry rapidly responded by making vaccine and multiple clinical trials to test vaccine are ramping up. Researchers are pouring a tremendous amount of effort and resources into delivering a safe and effective vaccine to the American public as quickly as possible.”
Frey, who is also on faculty at the Center for Vaccine Development at Saint Louis University, is a member of the team of infectious diseases researchers whose work will help scientists and public health officials develop the best strategy to protect Americans against 2009 H1N1 influenza.
“It’s looking more and more like we’re going to have a big flu outbreak this fall as soon as the kids get back to school. Influenza is unpredictable, but I believe this pandemic will hit pre-teens, teens and their parents hard, and as many as 60 million Americans could be sick with the flu. It’s critical that we find a way to protect people from this disease,” said Robert Belshe, M.D., director of the Center for Vaccine Development at Saint Louis University School of Medicine and a co- investigator for several of the national research studies.
"The modelers predict the peak will be in October, which means we’ll see more H1N1 influenza in September. We’ll be in the midst of it before we know it.”
The United States government declared the H1N1 influenza a public health emergency in April and two months later, the World Health Organization classified the H1N1 influenza as a pandemic, which reflects the widespread nature of the outbreak.
“So far, most of the infections are relatively mild. We’re hoping it’s going to stay that way, but we don’t really know,” Belshe said. “With the large number of people who are predicted to become infected, the number of serious health complications and even deaths could soar.”
This round of research studies will recruit thousands of healthy volunteers nationally to test the safety and measure the body’s immune response to an investigational H1N1 flu vaccine. They will include adult, pediatric and elderly volunteers.
Eight Vaccine and Treatment Evaluation Units (VTEUs) which are funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, will participate in these trials. In addition to the VTEU at Saint Louis University, the VTEU sites are Baylor College of Medicine; Emory University; University of Maryland School of Medicine in Baltimore; Children’s Hospital Medical Center in Cincinnati; Group Health Cooperative in Seattle; University of Iowa; and Vanderbilt University. They will be joined by Duke University Medical Center and Children’s Mercy Hospital in Kansas City.
Frey will lead the team of investigators who will study whether an experimental H1N1 influenza vaccine, which is not formulated to protect against the traditional seasonal flu, can be given with the seasonal influenza vaccine. http://clinicaltrials.gov/show/NCT00943878
The answer to that question is important, Frey said, because experts are predicting that both strains of influenza will circulate for much of the fall and winter. The studies will analyze potential problems of giving the vaccines together, such as whether one vaccine will undermine the protective power of the other.
In other H1N1 influenza trials, VTEU researchers will compare the immune response to different numbers of doses and different strengths of the H1N1 flu vaccine to see which is more effective. http://clinicaltrials.gov/show/NCT00943488 and http://clinicaltrials.gov/show/NCT00943631
NIAID-funded investigators are currently studying giving the common seasonal flu vaccine to pregnant women to get some baseline data for future comparisons they can use as they research giving the H1N1 vaccine to pregnant women. http://www.clinicaltrial.gov/ct2/show/NCT00905125?term=pregnancy+influenza&rank=5
Typically, vaccines are the most powerful weapon against influenza. About two or three weeks after getting the flu vaccine, the body mounts an immune response and makes antibodies that fight the flu virus. Those who are vaccinated may not get sick if they are exposed to influenza or may have a much milder or shorter case of the illness.
“Since vaccines work well to protect against the seasonal flu, we believe that an effective vaccine against 2009 H1N1 flu will help to control this pandemic,” Belshe said.
“But because we are predicting the H1N1 flu will hit sooner than the seasonal flu, which typically strikes between October and March and peaks in February, time is of the essence as we conduct our vaccine research.”
The H1N1 vaccine research soon will be expanded to include children. Frey added that pregnant women and those individuals who have underlying illnesses of the kidneys, liver, heart and lungs (including asthma) will face the biggest health danger from the 2009 H1N1 influenza.
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