From YAHOO
Tuesday December 14, 8:22 pm Eastern Time
Company Press Release
SOURCE: Aviron
Published Data Reports Aviron's FluMist(TM) Provided Protection Against Influenza
Mountain View, Calif., Dec. 14 /PRNewswire/ -- Aviron's (Nasdaq: AVIR - news) FluMist(TM), an investigational intranasal influenza vaccine, provided 85 percent protection from influenza in a challenge efficacy study of 92 healthy adults aged 18-45 who experienced direct (intranasal) exposure to the virus, according to results of a study published in the December issue of Vaccine.
Participants in the randomized, double-blind, placebo-controlled trial were pre-screened to confirm that they had not been previously exposed to the influenza viruses used in the challenge study. They then received either FluMist(TM) (also known as CAIV-T or cold adapted influenza vaccine trivalent), the flu shot (also known as TIV or trivalent influenza vaccine), or a placebo. Approximately 28 days following vaccination they were challenged intranasally with one of three wild-type influenza viruses.
The study team, led by John J. Treanor, M.D., associate professor of medicine, University of Rochester School of Medicine, Rochester, NY, reported that the estimated levels of protective efficacy against laboratory-confirmed influenza were 85 percent with FluMist(TM) and 71 percent with the flu shot. Both FluMist(TM) and the flu shot provided statistically significant protective efficacy compared to the placebo, however, the difference between these two protective efficacy numbers is not statistically significant. Laboratory-confirmed influenza illness occurred in 14/31 (45 percent) of the placebo recipients, 4/32 (13 percent) of the flu shot recipients and 2/29 (seven percent) of the FluMist(TM) recipients. Aviron announced preliminary results from this study in 1996, prior to peer review and publication.
``The efficacy data we observed with FluMist(TM) from this adult challenge trial is very encouraging since influenza can cause significant suffering, family disruption and work loss in healthy adults,' said Dr. Treanor.
Vaccination was generally well tolerated, with the most commonly reported symptoms in all three study arms being runny nose and cough. Overall, the rates of symptoms were similar for FluMist(TM), flu shot and placebo recipients.
``These results track very closely with other data on FluMist(TM),' said C. Boyd Clarke, president and chief executive officer of Aviron. ``In subsequent trials in healthy children, we have seen an overall protection rate as high as 93 percent (N=1602). Currently, only a small percentage of healthy children and adults are immunized against influenza. We think FluMist(TM) could eventually provide an attractive new option to these populations.'
Aviron is a biopharmaceutical company based in Mountain View, CA focused on prevention of disease. The company's goal is to develop products that offer cost-effective prevention of a wide range of infections that affect the general population. The majority of Aviron's products under development are live vaccines against viral infections. These include intranasal vaccines under development for respiratory infections and their complications -- influenza, parainfluenza (PIV-3), and respiratory syncytial virus (RSV), and injectable vaccines to prevent cytomegalovirus (CMV) and genital herpes (HSV-2). Aviron also is developing, in collaboration with SmithKline Beecham Biologicals, a subunit vaccine against Epstein-Barr Virus (EBV) infection, a major cause of infectious mononucleosis. Aviron and Wyeth Lederle Vaccines, a business unit of American Home Products, are collaborating on the development and marketing of FluMist(TM) worldwide except for Australia, New Zealand, Korea and certain other South Pacific region countries.
To receive an index and copies of recent press releases, call Aviron's News-On-Call toll-free fax service, 800-758-5804, extension 114000. Additional information about the company can be located at aviron.com.
SOURCE: Aviron |
