According to the government health officials, initial clinical trials show that China’s first AIDS vaccine is safe and probably effective//.
"Forty-nine healthy people who received the injections showed no severe adverse reactions after 180 days, proving the vaccine was safe," said Zhang Wei, head of the pharmaceutical registration department of the State Food and Drug Administration (SFDA).
"The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," he told a press conference in Beijing.
The first phase of clinical trials, which focused on the vaccine’s safety comes to an end with these results.
Sang Guowei, director of the National Institute for the Control of Pharmaceutical and Biological Products, said that the second-round tests will require at least 300 volunteers and the third phase at least 500.
According to Chen Jie, deputy director of the Guangxi Regional Center for Disease Control and Prevention, participation of high-risk groups will be involved in the later trials.
The first phase of clinical trials began in March 2005 in Nanning, which is the capital of the Guangxi Zhuang Autonomous Region. 33 men and 16 women aged between 18 and 50 years, volunteered for this trial. They were divided into 8 groups, of which, 6 groups were given a single AIDS vaccine and the others were injected with a combined AIDS vaccine. This was reported by the Guangxi center for disease control.
”The HIV-1 specific cells injected into the recipients were the DNA fragments of the virus that don't cause infection,” Sang said.
”Some recipients' cells and body fluids in the combined group appeared immune to the HIV-1 virus.”
Kong Wei, leader of the research team and a professor at Jilin University said, ”A total 344 blood samples were taken from the volunteers, with each one donating five
to 10 samples.”
The volunteers exhibited no serious ill effects even after 180 days of observation.
According to the SFDA officials, the scientists will continue analysis of the results of the first phase, before SFDA approves the beginning of the second phase, after a rigorous assessment.
Assessment of safety and immunity comprises the second phase while the third is concerned with how the vaccine will provide protection to the high-risk groups.
According to the 2005 Update on the HIV/AIDS Epidemic and Response in China, 6,50,000 people in this country are living with HIV/AIDS while 75,000 with clinical AIDS.
Scientists and other experts concerned with the drastic increase in the spread of the disease, urged the State Council, China's cabinet, to raise funding for and encourage innovation and cooperation in research.
International funding worth 123.2 million U.S. dollars was given to China recently by the Global Fund to Fight HIV/AIDS, Tuberculosis and Malria.
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