China hopeful over 1st tests of AIDS vaccine
19/8/2006 11:02
Initial clinical trials indicate China's first AIDS vaccine is safe and
possibly effective, government officials said yesterday.
"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.
"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 results mark
the end of the first phase of clinical trials, which focused on the vaccine's
safety.
Second-round tests will require at least 300 volunteers and the
third phase at least 500, Sang Guowei, director of the National Institute for
the Control of Pharmaceutical and Biological Products, said
yesterday.
The later trials will involve participation by high-risk
groups, said Chen Jie, deputy director of the Guangxi Regional Center for
Disease Control and Prevention.
The first phase began in Nanning, capital
of the Guangxi Zhuang Autonomous Region, in March 2005. The volunteers, 33 men
and 16 women between age 18 and 50 years old, were divided into eight groups.
Six groups received a single AIDS vaccine and the others were injected with a
combined AIDS vaccine, according to 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.
A total 344 blood samples were taken from the volunteers,
with each one donating five to 10 samples, said Kong Wei, leader of the research
team and a professor at Jilin University.
By June, all the volunteers had
completed 180 days of observation and showed no serious ill effects.
The
scientists will continue to analyze the results of the first phase before the
State Food and Drug Administration approves the start of the second phase after
a stringent assessment, SFDA officials said.
The second phase will
further assess safety and immunity, while the third will investigate the
protection it might offer for high-risk groups.
China has about 650,000
people living with HIV, the virus that causes AIDS, and some 75,000 AIDS
patients.
Scientists and other experts have urged the State Council,
China's cabinet, to raise funding for and encourage innovation and cooperation
in research, warning the disease is spreading quickly.
Xinhua news
|
