NIAID-sponsored clinical trial aims to boost flu vaccine supply
May 6th 2008 01:58 am
In an crack to increase the equip of cold vaccine at your disposal within the United States in the wished-for, a clinical tribunal of an virus vaccine widely previously own in Europe have begin recruit participant at four site empire. Funding in support of the den come from the National Institute of Allergy and Infectious Diseases (NIAID), constituent of the National Institutes of Health, which be collaborate next to the vaccine’s pioneer, GlaxoSmithKline Biologicals of Rixensart, Belgium, to conduct the study.
The latest trial aims to enroll 1,000 decent adults by the use of December 23rd to asking price the immune feedback and safekeeping of the vaccine. More than 126 million dose of the audition vaccine, Fluarix, personal be distributed in greater than 70 country communalist, demonstrating a corresponding safety profile by means of U.S.-licensed injectable flu vaccine, but the Fluarix vaccine has never been tested or licensed for pay cheque out in the United States.
On December 7, nevertheless, Department of Health and Human Services Secretary Tommy G. Thompson announced pleasure of a stratagem to introduction moving to 4 million doses of Fluarix to be distributed as an “investigational new drug” (IND). Under an IND, volunteers given the Fluarix vaccine must gap value an informed okay style acknowledge that they be cognisant of the give an undertaking risk and benefits associated with the investigational vaccine.
HHS has taken this rung to improve the U.S. influenza vaccine supply because ahead of juncture this year one of the two manufacturer of U.S.-licensed injectable flu vaccine be powerless to deliver its make.
“Expanding the digit of influenza vaccine wellspring is nit-picking as we prepared ourselves for subsequent year’s flu season,” read out NIAID Director Anthony S. Fauci, M.D. “The NIAID-supported Vaccine and Treatment Evaluation Units (VTEUs) are structured to execute clinical trial competently, enable us to gain needed information fast.” “Although the vaccine we are conduct test has a markedly protracted safety transcription in Europe and other parts of the world, the genus of study we are conducting must be done earlier the vaccine can be licensed for use in the United States,” log commander investigator John Treanor, M.D., of the University of Rochester Medical Center. The Rochester VTEU, added to to VTEUs in Baltimore, Cincinnati and Houston will be recruiting grown volunteers into the trial.
Four out of both five participants in the new trial will receive Fluarix, while the fifth will receive a placebo. Those reception placebo vaccine will be offered U.S.-licensed flu vaccine at the fasten of the month-long study.
Healthy adults relating the ages of 18 and 64 who have not received a flu shot this year are eligible. Participants will drop in the clinic twofold in the trajectory of the trial. The trial will be conduct at the subsequent to VTEUs: — University of Rochester Medical Center — Cincinnati Children’s Hospital — University of Maryland School of Medicine, Baltimore — Baylor College of Medicine NIAID is a entity of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports prime and applied research to avert, diagnose and gratification easily spread virus such as HIV/AIDS and other sexually air infection, influenza, tuberculosis, malaria and lawlessness from potential agents of bioterrorism. NIAID also supports research by the on the side of transplantation and immune-related illnesses, plus autoimmune disorder, asthma and allergies.
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