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10/26/2009 - News

Clinical Trials of Swine Flu Vaccine Set to Begin

By: June Chen, MD

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On July 22, 2009, two Australian biotechnology companies reported that they had begun the first human studies of a swine flu vaccine.

On July 22, 2009, two Australian biotechnology companies reported that they had begun the first human studies of a swine flu vaccine.

On the same day, the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that its Vaccine and Treatment Evaluation Units would soon be initiating five clinical trials of two candidate vaccines for the H1N1 virus, or swine flu.

 
There are currently eight university research hospitals located around the country in the Vaccine and Treatment Evaluation Unit (VTEU) network. Of the five planned swine flu vaccine trials, three will enroll healthy adult and elderly volunteers and two will be initiated in children. Due to the possible resurgence of 2009 H1N1 swine flu infections that may occur in the fall, these trials are being conducted in a compressed timeframe but with the high standards expected of studies in humans. The goals of these trials are to determine if the swine flu vaccines are safe in people of all ages, how large of a dose and how many doses are needed to protect against infection, and whether the swine flu vaccine can be administered at the same time as the seasonal flu vaccine.
 
Preliminary results from early samples in a subset of trial participants are expected to be available a few weeks after the trials begin. According to NIAID Director Anthony S. Fauci, M.D., these data will be factored into the decision-making process of how and if to implement a 2009 H1N1 flu immunization program this fall.
 
 

Source:

National Institutes of Allergy and Infectious Diseases News Release, July 22, 2009.

Created on: 07/28/2009
Reviewed on: 10/26/2009

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