m_kishuri
JF-Expert Member
- Jan 27, 2010
- 1,484
- 372
[h=1]HIV/AIDS vaccine developed at Western proceeding to human clinical trials - media conference[/h]
TORONTO - Canadian researchers have been given the green light for human testing of an experimental HIV vaccine, but the initial trial will determine only its safety, not whether the vaccine works to prevent infection with the virus.
The U.S. Food and Drug Administration granted approval for researchers at the University of Western Ontario to test the vaccine, which is based on a genetically modified killed whole virus.
The SAV001 vaccine, developed by the lab of Dr. Chil-Yong Kang with financial support from Sumagen Canada, has been shown to stimulate a strong immune response in preliminary toxicology tests.
"FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection," suggested Kang, whose research lab has spent the last 10 years developing the vaccine at a cost of about $10 million.
Kang said his team decided to seek FDA approval for the Phase I clinical trial because testing will be done in the United States, where the candidate vaccine is being produced. He said the stringent requirements of the U.S. regulatory body would also make it easier to seek approval for widespread commercialization of the vaccine in other countries in the future.
HIV Vaccine: FDA Approves Human Trials Of Promising Vaccine, Uses Killed Whole Virus
TORONTO - Canadian researchers have been given the green light for human testing of an experimental HIV vaccine, but the initial trial will determine only its safety, not whether the vaccine works to prevent infection with the virus.
The U.S. Food and Drug Administration granted approval for researchers at the University of Western Ontario to test the vaccine, which is based on a genetically modified killed whole virus.
The SAV001 vaccine, developed by the lab of Dr. Chil-Yong Kang with financial support from Sumagen Canada, has been shown to stimulate a strong immune response in preliminary toxicology tests.
"FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection," suggested Kang, whose research lab has spent the last 10 years developing the vaccine at a cost of about $10 million.
Kang said his team decided to seek FDA approval for the Phase I clinical trial because testing will be done in the United States, where the candidate vaccine is being produced. He said the stringent requirements of the U.S. regulatory body would also make it easier to seek approval for widespread commercialization of the vaccine in other countries in the future.
HIV Vaccine: FDA Approves Human Trials Of Promising Vaccine, Uses Killed Whole Virus
Last edited by a moderator:
