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China-developed AIDS vaccine enters phase II clinical trial
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Approved by the State Food and Drug Administration (SFDA), on March 21, 2009, China-developed AIDS vaccine formally entered phase II clinical trial. This is the first time that China conducts safety evaluation and explores the efficacy of AIDS vaccine among high-risk population.
The phase II clinical trial mainly aims to further evaluate the safety of AIDS vaccine in expanded high-risk healthy population and explore its efficacy on the base of phase I clinical trial, and to provide evidence for whether the clinical trials to assess the efficacy of AIDS vaccine can be continued.
The AIDS vaccine phase II clinical trial will be jointly conducted by Guangxi Center for Disease Control and Prevention, National Institute for the Control of Pharmaceutical and Biological Products, Jilin University National Engineering Laboratory for AIDS Vaccine, Changchun Baike Pharmaceutical Co., Ltd, and the research site located in Guangxi.
The first China-developed AIDS vaccine was approved to enter phase I clinical trial on November 25, 2004. On March 12, 2005, the first group of volunteers received inoculation in Guangxi Nanning. On August 18, 2006, the Ministry of Science and Technology and SFDA announced in Beijing that the first China-developed AIDS vaccine successfully completed the phase I clinical trial with satisfactory safety. The phase II clinical trial will publicly recruit over 200 volunteers to further test the safety and effectiveness of the vaccine.
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