Canadian researchers working to develop the world's first HIV vaccine announced on Tuesday that they have cleared a major hurdle. Initial results from a Phase I trial conducted by scientists at Western University has shown no adverse effects while significantly boosting immunity. The vaccine, which is based on a genetically modified, dead virus, can now progress to the next stage of testing. If all continues to go well, the vaccine could be commercially available in five years.
Since it first made its appearance in the early 1980s, HIV/AIDS has killed more than 28 million people worldwide, with more than 34 million people currently living with the virus infection. While there have been numerous attempts over the years to develop vaccines, nothing has worked to date. But if the early indications of this new vaccine is of any indication, that could soon change.
The vaccine, called SAV001-H, is being developed by Dr. Chil-Yong Kang and his team at Western's Schulich School of Medicine and Dentistry, with the support of Sumagen Canada. The now completed first-phase trial was a randomized, observer-blinded, placebo-controlled study involving infected men and women aged 18 to 50.
Results from the trials showed that patients experienced no adverse effects -- no local reactions from the injections, or any signs, symptoms, or reactions to potential toxicities. Given that the early results have shown safety and tolerability in humans, Sumagen and the Western researchers are now ready to embark upon the next phase of clinical trials to study the vaccine's immunity and effectiveness.
"We have proven that there is no safety concern of SAV001-H in human administration and we are now prepared to take the next steps towards Phase II and Phase III clinical trials," said Dr. Dong Joon Kim through the official release. "We are delighted to be one step closer to the first commercialized HIV vaccine."
Interestingly, the vaccine is unique in that it uses a killed whole HIV-a -- much like the killed whole virus vaccines that are used to treat polio, influenza, rabies and hepatitis A. A killed vaccine is a vaccine made from a previously virulent or infectious agent that has been inactivated or killed in some way, typically by radiation, heat, or chemicals. In this case, the HIV-1 was genetically engineered so that it is non-pathogenic and can be produced in large quantities.
The phase 2 trial, which will begin next year, will see the vaccine tested on 600 HIV-negative volunteers at high risk for infection. This will allow the researchers to measure immune response. For phase 3, it's hoped that 6,000 HIV-negative volunteers can be recruited from different countries who are also at high risk for infection.
In addition, Sumagen will be looking to collaborate with multi-national biopharmaceutical companies for globalizing clinical trials and commercialization. Sumagen Co. Ltd. is a Korean-based pharmaceutical venture company that was established to fund the development of the HIV vaccine.
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