Scientists in 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.
“With the emergence of the 2009 H1N1 influenza virus, we have undertaken a collaborative and efficient process of vaccine development that is proceeding in stepwise fashion,” says NIAID Director Anthony S. Fauci, M.D.
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 Dr. Fauci. “These data will be factored into the decision about how and if to implement a 2009 H1N1 flu immunization program this fall.”
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.
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.
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.