Cincinnati Children’s to Test H1N1 Vaccine

Wednesday, July 22, 2009

Cincinnati Children’s Hospital Medical Center is one of eight centers nationwide set to take part in upcoming clinical trials testing two experimental vaccines to protect against the 2009 H1N1 flu virus.

Cincinnati Children’s is one of eight university research hospitals or medical organizations in the nation that serve as Vaccine and Treatment Evaluation Units. The VTEUs provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases. This VTEU network is under the direction of and receives support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The VTEUs expect to recruit volunteers and test the vaccines beginning in August. In a National Institute of Allergy and Infectious Diseases news release, Anthony S. Fauci, MD, NIAID director, noted that “with the emergence of the 2009 H1N1 influenza virus, we have undertaken a collaborative and efficient process of vaccine development…to help quickly evaluate these pilot lots to determine whether the vaccines are safe and to assess their ability to induce protective immune responses. These data will be factored into the decision about how and if to implement a 2009 H1N1 flu vaccination program this fall.”

Information from these studies in healthy people will help public health officials develop recommendations for immunization schedules, including the optimal dosage and number of doses for multiple age and risk groups, including the elderly, children, pregnant women and people whose immune systems are weakened or compromised. The trials are being conducted in a compressed timeframe in a race against the possible autumn resurgence of 2009 H1N1 flu infections that may occur at the same time as seasonal influenza virus strains begin to circulate widely in the Northern Hemisphere.

The trials involve testing seasonal influenza vaccines (the regular flu shot that is distributed each fall and winter) and two candidate H1N1 flu vaccines from FDA-licensed manufacturers (Sanofi Pasteur and CSL Biotherapies). Researchers also hope to determine whether 2009 H1N1 flu vaccine can be given in combination with or shortly after seasonal flu vaccine.

“We are proud to be part of the effort to evaluate the new 2009 H1N1 influenza vaccines so we can ensure they are safe and effective before we begin making them available to the public," says David Bernstein, MD, director of infectious diseases at Cincinnati Children’s and lead investigator of the studies being conducted here. “Our success will depend on the cooperation and willingness of volunteers to participate in these studies.”

Further information about all H1N1 trials will be accessible from www.clinicaltrials.gov/ as they open. You can also learn more about the trials at Cincinnati Children's. For more information on influenza, visit www.flu.gov for one-stop access to U.S. government information on avian and pandemic influenza. Also, see www3.niaid.nih.gov/topics/Flu/.

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.

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 www.nih.gov.

For more information on vaccine studies at Cincinnati Children’s, call 513-636-7699 or email gambleprogram@cchmc.org.

About Cincinnati Children’s

Cincinnati Children’s Hospital Medical Center is one of 10 children’s hospitals in the United States to make the Honor Roll in U.S. News and World Reports 2009-10 Americas Best Children’s Hospitals issue. It is #1 ranked for digestive disorders and is also highly ranked for its expertise in respiratory diseases, cancer, neonatal care, heart care, neurosurgery, diabetes, orthopedics, kidney disorders and urology. One of the three largest children’s hospitals in the U.S., Cincinnati Children’s is affiliated with the University of Cincinnati College of Medicine and is one of the top two recipients of pediatric research grants from the National Institutes of Health.

President Barack Obama in June 2009 cited Cincinnati Children’s as an island of excellence in health care. For its achievements in transforming health care, Cincinnati Children’s is one of six U.S. hospitals since 2002 to be awarded the American Hospital Association-McKesson Quest for Quality Prize for leadership and innovation in quality, safety and commitment to patient care. The hospital is a national and international referral center for complex cases. Additional information can be found at www.cincinnatichildrens.org.