加拿大首个艾滋病疫苗获准开展人体试验（中文+英文）

加拿大首个艾滋病疫苗获准开展人体试验

加拿大西安大略大学12月20日宣布，该校研制的艾滋病疫苗获得美国食品和药物管理局批准，将于2012年开展人体试验检测其预防艾滋病的效果。这是目前加拿大研制的首个艾滋病疫苗。

该校研究小组利用基因技术改造艾滋病I型病毒，使其不具备致病性，再将其制备成疫苗。初步药理实验结果显示，这种疫苗能刺激强烈的免疫反应，起到预防艾滋病的作用，并且没有出现副作用。

新疫苗与此前开展人体试验的艾滋病疫苗不同，后者要么是以艾滋病病毒的某个特定成分为基础、用DNA重组技术制成的抗原疫苗，要么是以携带艾滋病病毒基因的重组病毒制成的疫苗。

新疫苗的人体试验分为3个阶段。第一阶段从2012年1月开始，将通过40名艾滋病病毒抗体呈阳性的志愿者，评估疫苗对人体的安全性。第二阶段将通过约600名属于艾滋病感染高危人群、但尚未感染艾滋病的志愿者，评估疫苗对人体的免疫反应。第三阶段通过约6000名属于艾滋病感染高危人群、但尚未感染艾滋病的志愿者，评估疫苗的有效性。

HIV/AIDS Vaccine Developed at The University of Western Ontario Proceeding to Human Clinical Trials 

London, ON– The first and only preventative HIV vaccine based on a genetically modified killed wholevirushas 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.

“FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection," says Kang, a researcher and professor at Western's Schulich School of Medicine & Dentistry.

Western President Amit Chakma says, "This joint venture between Sumagen and Western is a prime example of what collaboration between private industry and university researchers can achieve. Dr. Kang and his team are to be commended for their exceptional talent and remarkable persistence in developing a vaccine that addresses a tragic health crisis affecting millions of people around the globe." 

Dr. Dong Joon Kim, a representative of Sumagen Co. Ltd. says, “Our company has committed substantial resources to this project since 2005 and we are very pleased to reach this milestone.  It is our desire to continue growing our business in Canada and being a part of the business community in London.”

HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the virus infection. Since the virus was characterized in 1983, there have been numerous trials through pharmaceutical companies and academic institutions around the world to develop vaccines; however, no commercialized vaccine has been developed to date. Other HIV vaccines evaluated through human clinical trials have focused on either one specific component of HIV as an antigen, genetic vaccine using recombinant DNA, or recombinant viruses carrying the HIV genes. Kang’s vaccine is unique in that it uses a killed whole HIV-1, much like the killed whole virus vaccines for polio, influenza, rabies and hepatitis A. The HIV-1 is genetically engineered so it is non-pathogenic and can be produced in large quantities.

Before it can be commercialized, the SAV001 vaccine must go through three phases of human clinical trials:

• Phase I, set to begin in January 2012, will double check the safety of the vaccine in humans, involving only 40 HIV-positive volunteers.
• Phase IIwill measure immune responses in humans, involving approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection.
• Phase IIIwill measure the efficacy of the vaccine, involving approximately 6,000 HIV-negative volunteers who are also in the high-risk category for HIV infection.

ThroughWORLDiscoveries, Western’s technology transfer office, Sumagen Canada has secured patents for the SAV001 vaccine in more than 70 countries, including the U.S., the European Union, China, India and South Korea. The vaccine has been manufactured at a bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the U.S.

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About Sumagen Canada

Located in The Stiller Centre for Technology Commercialization in Western’s Research Park in London, Ontario,Sumagen Canadawas established in 2008 specifically to manage and support clinical development of Kang’s vaccine. Sumagen Canada is a subsidiary of Sumagen Co. Ltd., a Korean-based pharmaceutical venture company.

About The University of Western Ontario

Located in London, Ontario,The University of Western Ontariois one of Canada’s leading research-intensive universities, committed to producing generations of talented leaders and innovations of national benefit and global value and significance.

Media contact:

Jeff Renaud, Sr. Media Relations Officer, The University of Western Ontario, 519-661-2111 ext. 85165 (office)

Note to media:The University of Western Ontario has a live television broadcast studio on campus.