Happy New Year and O Canada! I realize that isn’t the traditional New Year’s greeting, but since 2012 looks to be the year Canada changes the face of AIDS worldwide, I thought I’d take it out for a test drive. Researchers at the University of Western Ontario have announced they have a promising new HIV vaccine. It’s called SAV001. And a few days from now human trials are going to begin. So may I say again, O Canada and your SAV001! You have finally put the prospect of an end to the AIDS plague within our grasp.
I understand if the mention of an HIV vaccine makes you want to warn me: Caution! Don’t get people’s hopes up. There’s a long road ahead. There have been failed vaccines before. Even if it works it will be years before a vaccine can be brought to market. I hear you. I do. But before you retreat to your safe place, with the sign out front that says: “Call me when you have a cure” I hope you will allow me to give you three good reasons not to dismiss SAV001 as just another someday rainbow.
The first thing that makes SAV001 different from any of the handful of other HIV vaccines under development is that it uses the same tried and true method that has produced the polio and rabies vaccines, using a dead strain of the HIV-1 virus. Dr. Chil-Yong Kang, who will oversee the human trials, explains the process in a video on the University’s website this way: We infect cells so they will produce lots of virus. We then collect them, purify them and then inactive them by chemicals and by radiation. When introduced into the human body, it will trigger the proper immune responses – making antibodies that will fight HIV infection.
The second signal that the SAV001 vaccine is seen by the medical and research communities as having real potential is the involvement of the US Food And Drug Administration. SAV001 is owned by Sumagen, a Korean company. The research is being done in Canada. Yet the US has been invited in, and has opted to become involved. They have already administered over 230 toxicology tests, which SAV001 passed. It showed no adverse side effects in rats and monkeys and has been genetically engineered so that it cannot cause HIV. Best of all it can be readily produced in large quantities
The third reason you should not be afraid to invest your hopes in the success of SAV001, has nothing to do with science or medicine. It is the furor of corporate activity behind the scenes. Since 1987, Sumagen has sustained Dr. Chil-Yong Kang’s HIV vaccine research project. In fact, this is the fourth vaccine the project has developed – but this is the very first vaccine that has prompted the company to initiate a world-wide long-range development and marketing plan. Look closely, and you will see a company convinced it has a winner.
In 2009, after 22 years of maintaining the status quo in their HIV vaccine research project, Sumagen took the unusual step of establishing a Canadian Division specifically for the development and marketing of SAV001. As a Korean Company, with a product produced in Canada, the US Food and Drug Administration had no reason to involve itself with the vaccine until testing was complete and Sumagen applied to market it in the States, yet Sumagen invited the FDA to involve itself in the trial process. And a final action of note, Sumagen has secured patents on SAV001 in over seventy countries.
The first phase is deliberately small, forty HIV positive patients will take the vaccine as a test to make sure it is not harmful to humans. Phase two will be larger, with 600 HIV negative subjects in high risk situations, like IV drug users, sex trade workers, or gay men who identify as having multiple partners. The third and final phase will expand that number to 6000 HIV negative high risk subjects, but run a parallel test with a control group not given the vaccine.
Yes, even if the trials are successful it will take some time until the vaccine can be brought to market. What’s the old saying? There’s many a slip between the cup and the lip? But here’s hoping we will very soon have a vaccine that will spell the beginning of the end to the scourge of AIDS. There is certainly reason for optimism. So happy New Year, and O Canada! O Korea! O FDA! And Go SAV001! Your time has come.