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Related Topics >> Clinical trial | swine flu | H1N1 | CSL | Australia

CSL begins first human trials of H1N1 vaccine


The first human trial of an H1N1 vaccine began Wednesday. Melbourne, Australia-based developer CSL has launched a human trial of its experimental H1N1 vaccine in partnership with the clinical research organization CMAX and the Royal Adelaide Hospital in South Australia. The seven-week trial involves 240 healthy adult volunteers aged 18 to 64 and 400 children aged six months to nine years. Participants will receive two injections of the vaccine three weeks apart.

Researchers plan to administer a standard dosage as well as an increased dosage to determine which produces the best immune response. And vaccine developers, many of whom also have orders already on the table, will be watching this trial closely to help guide their own dosing, Marie-Paule Kieny, director of the World Health Organization's initiative for vaccine research, told Bloomberg. "It is likely to be indicative of how the other vaccine candidates will perform."

The lone vaccine developer in the southern hemisphere, CSL has thus far promised vaccine to its home country, the U.S. and Singapore. 

Meanwhile, the National Institutes of Health is prepping for trials of CSL's, as well as Sanofi-Pasteur's, vaccines here in the U.S. as well. On Wednesday, the government called on volunteers to enroll in trials at eight medical centers around the country. Testing is set to kick-off the second week of August and officials hope to have an idea of how much antigen is necessary by early September. The NIH will first test the vaccine on adults to evaluate the safety of the jabs before enrolling children and babies in the trials.  

Testing will be conducted at the University of Maryland School of Medicine, the University of Iowa, St. Louis University, Baylor College of Medicine, Cincinnatti's Children's Hospital Medical Center, Emory University, Seattle's Group Health Cooperative and Vanderbilt University.

- here's CSL's release
- more on the NIH testing
- here's the Bloomberg article
- read CNN's take

ALSO: Clinical trials are also underway in China. More than 2,000 volunteers have been given the jab in trials being carried out by Hualan Biological Engineering. Report

Related Articles:
Countries place huge vax orders, ready campaigns
Inovio touts results of preclinical swine flu vax test
Novartis readies trial as H1N1 orders pour in

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