Kanta Subbarao, Respiratory Viruses Section
November 25, 2009
Two 2009 H1N1 influenza vaccine studies sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, have begun recruiting volunteers at the University of Rochester Medical Center, New York. One trial will compare blood samples from older and younger volunteers to determine the effects of age on pre-existing immune protection against the 2009 H1N1 flu virus before and after vaccination with an injected 2009 H1N1 vaccine. The second trial will develop a detailed picture of the immune system’s reaction to a nasal spray form of the vaccine. NIAID influenza researchers led by Kanta Subbarao, M.D., will collaborate with the University of Rochester’s John Treanor, M.D., and his colleagues to analyze immune responses to the trial vaccines.
The first trial will enroll a total of 60 healthy adults: 20 between 18 and 32 years old, 20 between 60 and 70 years old, and 20 older than 70. Volunteers will receive one dose of a licensed, inactivated 2009 H1N1 vaccine made by Novartis and delivered by injection. Analysis of blood samples taken prior to vaccination will enable the researchers to determine whether the volunteers—particularly those aged 60 years or older—have any pre-existing immunity to ancestors of the pandemic 2009 H1N1 influenza virus. One objective of this trial is to determine how exposure to forms of seasonal H1N1 influenza virus that circulated decades ago affects an individual’s immune response to the inactivated 2009 H1N1 vaccine.
The second trial will enroll 20 healthy adults 18 to 32 years old. Volunteers will receive two doses of MedImmune’s licensed, live, attenuated 2009 H1N1 vaccine administered as a nasal spray. The live virus in the vaccine is weakened enough so that it cannot cause disease but can prompt an immune response. Study staff will swab the volunteers’ nasal passages daily for seven days following each vaccination. The researchers will analyze these samples to learn how long the vaccine virus remains in the nose. The NIAID team and collaborators will use an array of assays to develop a day-by-day picture of how multiple components of the immune system, including cells in the nasal mucosa, respond to the vaccine. This information could help guide the development of future live, attenuated vaccines against other influenza viruses with pandemic potential.
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Last Updated November 25, 2009