[BEIJING] China's State Food and Drug Administration (SFDA) approved the country's first human trial of a potential HIV/AIDS vaccine yesterday (25 November). The phase I clinical trial will test the vaccine's safety on thirty volunteers.
The results will determine whether the vaccine will go on to phase II and III trials to test its safety and efficacy in more detail.
The vaccine, jointly developed by Changchun BCHT Pharmaceutical Company and Changchun-based Jilin University, has already been tested on monkeys. Researchers gave monkeys the potential vaccine then infected them with the HIV virus, and found no abnormal reactions to the drug, according to the SFDA.
The vaccine has also passed the viral safety test of China's National Institute for the Control of Pharmaceutical and Biological Products.
SFDA officials say a detailed plan for the clinical trial will be released in January 2005. The phase I trial will then be undertaken in Guangxi Zhuang Autonomous Region, in southern China. The trial will be funded entirely by Changchun BCHT, which plans to invest US$12.1 million in the vaccine.
Zeng Yi, chief scientist of the China Centre for HIV/AIDS Prevention and Control, estimates that it would take at least five years for a potential HIV/AIDS vaccine to complete phases I to III of clinical trials.
According to the SFDA, research on the potential HIV/AIDS vaccine against local strains of the virus began in 1996.
The so-called 'compound vaccine' consists of a DNA vaccine and a recombinant adenovirus vector, which will be injected separately into volunteers. Together, the two components can stimulate the production of antibodies against HIV/AIDS.
The International AIDS Vaccine Initiative has said dozens of potential vaccines are being tested worldwide, and more than 70 human clinical trials have taken place although none has yet looked set to conquer the virus.
Other researchers in China, including a team led by Zeng, are developing at least seven more HIV/AIDS vaccines, but none of these has so far received approval for human testing.
The Ministry of Health estimates that there are 840,000 HIV carriers in China, and about 80,000 patients with full-blown AIDS have been reported. Experts warn that without effective control measures, the number of HIV carriers could exceed ten million by 2010.