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First Chinese volunteers received AIDS vaccine inoculations



On March 12, 2005, a man of around 20 years old, as a volunteer for AIDS vaccine double blind trials, received China's first AIDS vaccine inoculation or placebo injection at the Guangxi Center for Disease Control. This is China's first clinical study of AIDS vaccines.

Eight volunteers, including four men and four women, were inoculated AIDS vaccines or placebos. After fifty minutes of clinical observation, the volunteer showed no signs of systemic or local adverse reaction. In line with international practice, they had previously signed Informed Consent Forms and received physical checkups.

In the Phase I of this vaccine trial, 49 volunteers, aged from 18 to 50 years old, will be selected from non-infected, healthy people. They will be divided into eight groups, adopting the methods of double blind trials and random grouping.

More than 20 experts from China's clinical and vaccine research areas finalized a scientific plan for clinical trial after strict preparation. After the State Food and Drug Administration (SFDA) approved the Phase I clinical trial of compound AIDS vaccines on Nov. 25,2004, the vaccine developer entrusted the National Institute for the Control of Pharmaceutical and Biological Products (NICPBP) to organize clinical research for the vaccine.

The vaccine clinical study consists of three phases and the Phase I trial will last 14 months. If the Phase I research finishes smoothly and is approved by SFDA, researchers will start the Phase II trial to evaluate the vaccine immunogenicity and expand tests for safety.

The AIDS vaccine is developed by the researchers of Changchun Baike Pharmaceutical Co., Ltd. and Jilin University Vaccine Research Center.



China-developed AIDS vaccine enters phase I clinical trial