加拿大首個艾滋病疫苗獲準開展人體試驗（中文+英文）

加拿大首個艾滋病疫苗獲準開展人體試驗

加拿大西安大略大學12月20日宣布，該校研製的艾滋病疫苗獲得美國食品和藥物管理局批準，將於2012年開展人體試驗檢測其預防艾滋病的效果。這是目前加拿大研製的首個艾滋病疫苗。

該校研究小組利用基因技術改造艾滋病I型病毒，使其不具備致病性，再將其製備成疫苗。初步藥理實驗結果顯示，這種疫苗能刺激強烈的免疫反應，起到預防艾滋病的作用，並且沒有出現副作用。

新疫苗與此前開展人體試驗的艾滋病疫苗不同，後者要麽是以艾滋病病毒的某個特定成分為基礎、用DNA重組技術製成的抗原疫苗，要麽是以攜帶艾滋病病毒基因的重組病毒製成的疫苗。

新疫苗的人體試驗分為3個階段。第一階段從2012年1月開始，將通過40名艾滋病病毒抗體呈陽性的誌願者，評估疫苗對人體的安全性。第二階段將通過約600名屬於艾滋病感染高危人群、但尚未感染艾滋病的誌願者，評估疫苗對人體的免疫反應。第三階段通過約6000名屬於艾滋病感染高危人群、但尚未感染艾滋病的誌願者，評估疫苗的有效性。

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.