INFLUENZA CVD 9000

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Description of Project (Abstract): Influenza is a common respiratory infection caused by several related viruses. Epidemics of influenza occur each winter and are responsible for an average of about 36,000 deaths each year in the United States. Most of these deaths occur among elderly persons and among people of all ages who suffer from chronic diseases, particularly of the lungs and the heart. Current influenza virus vaccines protect elderly persons against influenza, but not as well as desired. One consideration for trying to increase protection is to increase the vaccine dose, but there is some concern that increasing the dose may increase reactions to the vaccine (such as sore arm, aches, or fever). One of the licensed U.S. influenza vaccine manufacturers (Aventis Pasteur) has prepared an experimental influenza virus vaccine with a dose that is about 4 times higher than the currently used dose. A previous study with a similarly prepared high dose of the vaccine conducted in elderly subjects in 2002, showed that the high dose vaccine was well tolerated with only increased reactions at the injection site compared to the usual vaccine. Since the 2002 study, the high-dose vaccine has also been made without preservative (thimerosal) and gelatin, which are in the standard vaccine. It is expected that this vaccine can be given with little reaction, but this needs to be determined. It also needs to be shown whether such a vaccine stimulates higher levels of infection-fighting proteins (or antibodies) in the blood than standard doses of influenza vaccine. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (NIAID/NIH) is sponsoring this research study. The purpose of this research study is to compare reactions and antibody responses in subjects who are vaccinated with either a single dose of a standard flu vaccine or the experimental high dose vaccine. The experimental vaccine includes approximately four times the amount of each of three influenza virus proteins that are in the standard vaccine. Both the standard vaccine and the high dose vaccine contain the three influenza virus proteins that were recommended by the U.S. FDA for the 2004-2005 influenza season. About 400 subjects will be enrolled in this study nationwide. This research study is being conducted at the following 4 places(s): ¿ The University of Maryland ¿ Baylor College of Medicine ¿ Cincinnati Hospital Medical Center ¿ St. Louis University Health Sciences Center This clinical trial will be conducted as a prospective, double-blind, randomized, active-controlled trial. Ambulatory volunteers, ages 65 years and older, who meet the entry criteria for this study, will be randomized (1:1) to receive a single IM injection of either the high-dose (60mcg/virus strain) or standard-dose (15mcg/virus strain) of Aventis Pastuer 2004-2005 trivalent inactivated influenza vaccine. Subjects will be observed in the clinic for at least 20 minutes after immunization and will maintain a memory aid to record daily oral temperature and any systemic and local reactions for 7 days after the day of immunization. Volunteers will be contacted by phone between 8 to 12 days after immunization to review their 7-day memory aid, including the assessment of their daily oral temperature, any local or systemic reactions and the occurrence of any other AEs. Volunteers will return at Day 28 for a blood draw for immunogenicity evaluations. At approximately 6 months, the volunteers will either return to the study site or be contacted by phone to assess the occurrence of SAEs. Following completion of the study, former subjects will be offered a dose of the 2005-2006 Fluzone vaccine at no charge.