14 DAY TRIAL // Yesterday, September 3, Sumagen Canada Inc and the Western University went public with the news that an HIV/AIDS vaccine they had developed performed surprisingly well during a Phase I clinical trial that lasted from March 2012 until August 2013.
They said that none of the volunteers who were administered this vaccine, dubbed SAV001-H, displayed any serious adverse effects.
On the contrary, their bodies started producing more antibodies than they would have in the absence of the vaccine.
Given the fact that this clinical trial was randomized, observer-blinded and placebo-controlled, there is little doubt that its outcome is accurate.
As explained on the official website for the Western University, the vaccine was tested on men and women between the ages of 18 and 50. These people were all infected with HIV, yet asymptomatic.
Researchers are now getting ready to roll out a Phase II clinical trial, during which they will focus on the immune system and its reactions to the vaccine.
They are confident that it will not be long until the vaccine will become available for commercialization.
“Even though Sumagen has struggled and spent a much longer time to overcome manufacturing difficulties and to meet the U.S. FDA's requirements, we have accomplished successfully Phase I Clinical Trial of SA001-H and proven that there is no safety concern of SAV001-H in human administration.”
“We are now prepared to take the next steps towards Phase II and Phase III clinical trials. We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine,” said Mr. Jung-Gee Cho, the current CEO of Sumagen Co. Ltd.
Scientists working on developing this vaccine explain that it is the first in the world to be engineered using a modified killed whole virus.
The SAV001-H HIV vaccine was developed in Canada, and it is one of the few in the world currently undergoing clinical trials.