July 22, 2009
Group Health researchers set to launch clinical trials to test H1N1 flu vaccine candidates
Seattle—Scientists at Group Health Cooperative—along with a network of medical research institutions across the United States—are set 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 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—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."
Group Health expects to begin its trials by the end of August. 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.
Group Health expects to begin recruiting volunteers for these studies from its membership and the general public beginning in early August. For more information about vaccine trials for people aged 18 and older, call Group Health Center for Health Studies at 206-287-2061 or toll free 866-883-6772. For information about vaccine trials for those age 17 and younger, call 206-884-1100.
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 Hospital Research Institute to operate the VTEU in Seattle.
An important strength of the VTEUs 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 Hospital Research Institute.
Group Health Center for Health Studies
Group Health Research Institute does practical research that helps people like you and your family stay healthy. The Institute is the research arm of Seattle-based Group Health Cooperative, a consumer-governed, nonprofit health care system. Founded in 1947, Group Health Cooperative coordinates health care and coverage. Group Health Research Institute changed its name from Group Health Center for Health Studies in 2009. Since 1983, the Institute has conducted nonproprietary public-interest research on preventing, diagnosing, and treating major health problems. Government and private research grants provide its main funding.