Australian Firms Begin First Tests of Swine Flu Vaccine
The country has reported about 15,000 cases of the new H1N1 virus and 41 deaths.
July 22, 2009— -- Two biotechnology companies in Australia have begun the first human trials of a vaccine for the 2009 H1N1 (swine flu) virus.
Adelaide-based Vaxine Pty Ltd and Melbourne-based CSL Biotherapies injected the first adult volunteers this week in separate trials starting days apart.
Now in its winter flu season, Australia has reported about 15,000 confirmed cases of the new H1N1 virus and 41 deaths. That has made Australian health officials and drug manufacturers anxious to get a vaccination program under way as soon as possible.
"The demand [for a vaccine] was here yesterday," Nikolai Petrovsky, Vaxine chairman and research director, told the Associated Press.
Vaccine trials are expected to begin shortly in the United States as well. The U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee will meet tomorrow to discuss clinical trials of an H1N1 vaccine and vaccine approval.
Vaxine began injecting participants in its 300-person trial on Monday with a synthetic vaccine "based on state-of-the-art recombinant protein technology combined with our proprietary polysaccharide adjuvant system," Petrovsky said in a statement.
He said preliminary effectiveness data should be available in six to eight weeks.
On Wednesday, CSL Biotherapies began administering vaccine in a 240-person trial that is expected to last seven months. The study is being conducted in partnership with CMAX, a clinical research organization, and Royal Adelaide Hospital, according to a company statement.
All of the participants will receive two injections spaced three weeks apart. Half will receive a standard dose and half will receive a double dose.
"We appreciate that new influenza strains like the 'swine flu' can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans," Dr. Russell Basser, CSL's global director of clinical development, said in a statement.
"CSL will be addressing these questions in the trial to ensure we know the optimum way for the vaccine to be given to protect against this strain of flu," he said.
Dr. John Treanor, a vaccine researcher at the University of Rochester in New York, said "information from this trial will be very useful for all who are working with novel H1N1 vaccines, especially in determining what kind of response to expect with a single dose."
Dr. Rachel David, CSL's director of public affairs, told ABC News in Australia that a trial involving 400 children ages 6 months to 9 years will begin next month at Women's and Children's Hospital in Adelaide.
She also noted that there was no additional safety risk with this vaccine because it is produced in the same manner as seasonal vaccines.
"The substitution of one strain for another in the vaccine is not considered to be a significant change and, from the experience accrued, this is a reasonable presumption," commented Dr. Donald Henderson of the University of Pittsburgh and Johns Hopkins.
CSL has received a $180 million order from the U.S. Department for Health and Human Services for bulk antigen.
In addition, the Australian government has ordered 21 million vaccine doses from CSL, enough for the entire population, according to multiple media reports.
This article was developed in collaboration with ABC News.