Beijing -- Clinical trials indicate China's first AIDS vaccine is safe and
possibly effective, government officials announced on Friday.
Forty-nine healthy people who received the injection 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).
Two volunteers (1st right, 2nd left) for AIDS
vaccine test talk to doctors at the Guangxi Center for Disease
Prevention and Control after being injected with AIDS vaccine in this June
11, 2006 photo. China announced on Friday that the vaccine is safe and
possibly effective. [Xinhua] |
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, said Zhang at a press conference held jointly by the SFDA and the
Ministry of Science and Technology.
The results mark the end of the first phase of the clinical trials of the
AIDS vaccine, which targeted at safety.
The first phase was launched in Nanning, capital of Guangxi Zhuang Autonomous
Region, on March 12 last year. The volunteers, 33 men and 16 women aged between
18 and 50, had received the vaccine by October 20.
They were divided into eight groups. Six groups received a single AIDS
vaccine and two other groups were injected with a combined AIDS vaccine,
according to Guangxi Regional Center for Disease Control and Prevention (CDC).
Some recipients' cells and body fluids in the combined group appeared immune
to HIV-1 virus, said Sang Guowei, director of the National Institute for the
Control of Pharmaceutical and Biological Products.
The HIV-1 specific cells injected into the recipients was the DNA fragments
of the virus and was harmless to the recipients, he told Xinhua.
A total of 344 blood samples were taken from the volunteers with each one
donated five to ten samples, according to Kong Wei, the leader of the research
team who is a professor of Jilin University.
The scientists are analyzing the results of the first phase and will decide
whether to continue to the second phase, SFDA officials said.
If the test enters the second phase, more volunteers will be recruited,
especially from the high-risk groups, said Chen Jie, deputy head of the
Guangxi's CDC.
It was a breakthrough in China's AIDS vaccine development, which was achieved
with joint supports from the central and local governments, scientific
researchers, the general public and international counterparts, said Liu Yanhua,
vice minister of the Ministry of Science and Technology.
The State Food and Drug Administration approved the first phase of clinical
trials of the new AIDS vaccine in November 2004.
The vaccine must undergo three phases of clinical trials before going into
production. The second phase will assess both safety and and immunity while the
third will target the protectiveness for high-risk groups.
China has approximately 650,000 people living with HIV, including
approximately 75,000 AIDS patients, according to official estimates.
| 1 | 2 |  |
