Tag Archives: vaccine
A major announcement scheduled for Tuesday at Western University.
According to a news release, Western University and Sumagen Canada will unveil “preliminary results for the first-ever human applied clinical study of the world’s only preventative HIV vaccine.”
A news conference is set for 11 a.m. Tuesday at Western University.
AM980 will have a reporter on hand for the announcement.
The vaccine made international headlines when Western University’s Dr. Chil-Yong Kang announced in December 2011 his team had received permission from the U.S. Food and Drug Administration to begin clinical trials in humans.
Those trials, involving 40 HIV-positive volunteers, began in March 2012.
Depending on the outcome the vaccine would advance to a second phase which measures “immune responses in humans, involving approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection.”
The third, and final phase, would measure “the efficacy of the vaccine, involving approximately 6,000 HIV-negative volunteers who are also in the high-risk category for HIV infection.”
Scientists at Western University, financially backed by the pharmaceutical venture company Sumagen, developed the vaccine, which is based on a genetically modified killed whole virus. The vaccine stimulated a strong immune response in early testing and appears to have no adverse effects, according to the researchers.
London, Ontario CANADA –The first and only preventative HIV vaccine based on a genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA) to start human clinical trials.
Developed by Dr. Chil-Yong Kang and his team at The University of Western Ontario, with the support of Sumagen Canada, the vaccine (SAV001) holds tremendous promise, having already proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or safety risks. It is the only HIV vaccine currently under development in Canada, and one of only a few in the world.
Every 10 minutes, someone in the United States is infected with HIV. A preventive vaccine against HIV offers the best long-term hope to end this worldwide epidemic. Finding a safe and effective HIV vaccine that will protect people is a huge task. We cannot do it without your help.
* We are currently seeking 1350 men who have sex with men to participate in a vaccine trial.
* You cannot become infected with HIV from the vaccines
* The study will take place in several cities in the United States.
Safety is a primary goal of the vaccine trial. This is a Phase II study, designed to yield limited information on the effectiveness of the vaccine. The research vaccines have been found to be safe in animals and hundreds of humans in previous trials. One of the vaccines is made from an inactivated cold virus known as an adenovirus. The vaccines do NOT contain the HIV virus, and CANNOT cause HIV infection. Since these vaccines are still being researched, we urge all of our participants to practice safe sex.