December is upon us, which brings with it the start of winter, the end of the year, and the hustle and bustle of the holiday season. December also brings us International AIDS Awareness Month, which kicks off with World AIDS Day on December 1st. This year, a few hardworking scientists will have a reason to mark this time with hope and optimism for the future, as major gains have recently been made in the fight against HIV/AIDS.
On November 6th, a news conference was held at The University of Western Ontario (in London, Ontario, Canada) featuring the results of Phase I of a new HIV vaccine human clinical trial. Dr. Chil-Yong Kang and his team at Western’s Schulich School of Medicine & Dentistry partnered with Sumagen Canada to develop one of the world’s few HIV vaccines – and as per the news conference, results are promising thus far.
Dr. Kang’s vaccine project (called SAV001-H) is a randomized, observer-blinded, placebo-controlled study. It is also unique in that it’s the world’s only vaccine utilizing a genetically modified killed whole HIV virus. This method has been successful in the past, as vaccines for polio, influenza, rabies, and Hepatitis A were created in the same manner.
During Phase I (which began March 2012), 24 HIV-positive volunteers in the United States were administered the vaccine and monitored for any adverse effects. Sumagen and the Western team announced that the project had progressed smoothly, with no negative reactions, symptoms, or toxicities reported. In fact, testing showed that volunteers who received the vaccine had healthier immune systems, as noted by their increased antibody production.
After a successful Phase I, Dr. Kang and team will now apply to the U.S Food and Drug Administration to proceed with Phase II – where the vaccine will be administered to 300-600 HIV negative volunteers at high risk for infection. Phase III will entail screening of the vaccine for its efficacy – where 6000 HIV-negative volunteers at high risk for infection will be administered the drug and followed for a period of 3 years.
Dr. Kang spoke at the news conference, stating the following:
“My personal motivation is that I am a virologist and I like to save lives. That is my strongest motivation. It was Jenner (Dr. Edward Anthony Jenner) who developed the vaccine against small pox which saved millions and millions of lives over the years. If we can eradicate or prevent the HIV infection, that will be the happiest achievement I can accomplish.”
What do you think of this human clinical trial? If it passes all phases successfully and hits the market, how do you see this changing our mentality around HIV/AIDS and safe sex