In an effort to expand the supply of flu vaccine available in the United States in the future, a clinical trial of an influenza vaccine widely used in Europe has begun recruiting participants at four sites nationwide. Funding for the study comes from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, which is collaborating with the vaccine's manufacturer, GlaxoSmithKline Biologicals of Rixensart, Belgium, to conduct the study.
The new trial aims to enroll 1,000 healthy adults by December 23rd to assess the immune response and safety of the vaccine. More than 126 million doses of the test vaccine, Fluarix, have been distributed in more than 70 countries worldwide, demonstrating a similar safety profile as U.S.-licensed injectable flu vaccine, but the Fluarix vaccine has never been tested or licensed for use in the United States.
On December 7, however, Department of Health and Human Services Secretary Tommy G. Thompson announced approval of a plan to import up to 4 million doses of Fluarix to be distributed as an "investigational new drug" (IND). Under an IND, volunteers given the Fluarix vaccine must first sign an informed consent form acknowledging that they are aware of the potential risks and benefits associated with the investigational vaccine.
HHS has taken this step to augment the U.S. influenza vaccine supply because earlier this year one of the two manufacturers of U.S.-licensed injectable flu vaccine was unable to deliver its product.
"Expanding the number of influenza vaccine sources is critical as we ready ourselves for next year's flu season," says NIAID Director Anthony S. Fauci, M.D. "The NIAID-supported Vaccine and Treatment Evaluation Units (VTEUs) are structured to perform clinical trials efficiently, enabling us to get needed information rapidly."
"Although the vaccine we are testing has a very long safety record in Europe and other parts of the world, the type of study we are conducting must be done before the vaccine can be licensed for use in the United States," notes lead investigator John Treanor, M.D., of the University of Rochester Medical Center. The Rochester VTEU, in addition to VTEUs in Baltimore, Cincinnati and Houston will be recruiting adult volunteers into the trial.
Four out of every five participants in the new trial will receive Fluarix, while the fifth will receive a placebo. Those receiving placebo vaccine will be offered U.S.-licensed flu vaccine at the conclusion of the month-long study.
Healthy adults between the ages of 18 and 64 who have not received a flu shot this year are eligible. Participants will visit the clinic twice in the course of the trial. The trial will be conducted at the following VTEUs:
* University of Rochester Medical Center * Cincinnati Children's Hospital * University of Maryland School of Medicine, Baltimore * Baylor College of Medicine
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.
Materials provided by NIH/National Institute Of Allergy And Infectious Diseases. Note: Content may be edited for style and length.
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