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Seattle Researchers to Test H1N1 Flu Vaccine

July 23, 2009

2009-07-23 Research Group Health Cooperative is collaborating with the University of Washington (UW) Department of Medicine, the UW Division of Allergy & Infectious Diseases, and Seattle Children’s Research Institute, along with a network of medical research institutions across the United States,

Group Health Cooperative is collaborating with the University of Washington (UW) Department of Medicine, the UW Division of Allergy & Infectious Diseases, and Seattle Children’s Research Institute, along with a network of medical research institutions across the United States, to begin a series of clinical trials to gather critical data about influenza vaccines, including two candidate H1N1 flu vaccines.

The research will be under the direction of the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

After the isolation and characterization of the virus, the U. S. Centers for Disease Control and Prevention (CDC) generated and distributed a 2009 H1N1 seed virus to vaccine manufacturers for the development of vaccine pilot lots for testing in clinical trials.

“Now, NIAID will use our longstanding vaccine clinical trials infrastructure — the Vaccine and Treatment Evaluation Units or VTEU — to help quickly evaluate these pilot lots to determine whether the vaccines are safe and to assess their ability to induce protective immune responses,” says NIAID Director Anthony S. Fauci, M.D. “These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall.”

Trials are expected to begin by the end of August 2009. Initial studies will look at whether one or two 15 microgram doses of H1N1 vaccine are needed to induce a potentially protective immune response in healthy adult volunteers (aged 18 to 64 years old) and elderly people (aged 65 and older). Researchers also will assess whether one or two 30 microgram doses are needed. The doses will be given 21 days apart, testing two manufacturers’ vaccines (Sanofi Pasteur and CSL Biotherapies). If early information from those trials indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will begin.

Volunteers Needed

For those interested to participate in vaccine trials for children up through age 17, please call the Seattle Children’s vaccine trial line at 206-884-1100. Those interested in volunteering for vaccine trials for adults age 18 and older, please call the Group Health Center for Health Studies at 206-287-2061 or toll free 866-883-6772.

A concurrent set of trials will look at the safety and immune response in healthy adult and elderly volunteers who are given the seasonal flu vaccine along with a 15 microgram dose of 2009 H1N1 vaccine. The H1N1 vaccine would be given to different sets of volunteers either before, after, or at the same time as the seasonal flu vaccine. If early information from those studies indicates that these vaccines are safe, similar trials in healthy children (aged 6 months to 17 years old) will start.

“The H1N1 flu virus has the potential to cause significant illness in the fall and winter flu season,” said Lisa Jackson, MD, MPH, principal investigator of the VTEU at Group Health Center for Health Studies. “Vaccines are a proven method for preventing a flu epidemic. The results of these studies will help us make the best use of H1N1 vaccine in Washington state and around the world.”

A panel of outside experts will conduct a close review of the safety data from these trials to spot any safety concerns in real time. 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 groups, including adults, the elderly, and children. Data may also be used to support decisions about the best recommendations for people in high risk groups, including pregnant women and people whose immune systems are weakened or otherwise 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 VTEU network consists of eight university research hospitals and medical organizations across the United States that provide a ready resource for conducting clinical trials that evaluate vaccines and treatments for a wide array of infectious diseases.

Group Health is collaborating with the University of Washington (UW) Department of Medicine, the UW Division of Allergy & Infectious Diseases, and Seattle Children’s Research Institute to operate the VTEU in Seattle.

An important strength of the VTEU is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to counteract emerging public health concerns. Results are expected to be available weeks after the trials begin.

NIAID’s Vaccine and Treatment Evaluation Units include the following:

- Baylor College of Medicine, Houston
- Children’s Hospital Medical Center, Cincinnati
- Emory University, Atlanta
- Group Health Cooperative, Seattle
- Saint Louis University, St. Louis
- University of Iowa, Iowa City
- University of Maryland School of Medicine, Baltimore
- Vanderbilt University, Nashville, Tenn.

Co-investigators for the Group Health Cooperative VTEU are Dr. Anna Wald, professor in UW’s Department of Medicine and Division of Allergy & Infectious Disease, and Dr. Janet Englund, professor of pediatrics in the Department of Infectious Diseases at Seattle 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/ and http://www3.niaid.nih.gov/news/QA/vteuH1N1qa.htm.

About Seattle Children’s Research Institute

Located in downtown Seattle’s biotech corridor, Seattle Children’s Research Institute is pushing the boundaries of medical research to find cures for pediatric diseases and improve outcomes for children all over the world. Internationally recognized investigators and staff at the research institute are advancing new discoveries in cancer, genetics, immunology, pathology, infectious disease, injury prevention and bioethics, among others. As part of Seattle Children’s Hospital, the research institute brings together leading minds in pediatric research to provide patients with the best care possible. Seattle Children’s serves as the primary teaching, clinical and research site for the Department of Pediatrics at the University of Washington School of Medicine, which consistently ranks as one of the best pediatric departments in the country. For more information, visit http://www.seattlechildrens.org/research.

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