By Xinhua writers Li Xing, Cui Qingxin
BEIJING, Aug. 18 (Xinhua) -- At least 800 volunteers
will be needed for China's second and third phases of AIDS vaccine trials,
health officials said Friday.
The second phase of clinical trials of China's AIDS
vaccine would need at least 300 volunteers and the third phase at least 500,
said Sang Guowei, director of the National Institute for the Control of
Pharmaceutical and Biological Products.
Sang revealed the plan at a press conference held
jointly by the State Food and Drug Administration (SFDA) and Ministry of Science
The later trials would involve the participation of
high-risk groups, said Chen Jie, deputy director of the Guangxi Regional Center
for Disease Control and Prevention (CDC).
The first phase of clinical trials indicates China's
first AIDS vaccine is safe and possibly effective, government officials
announced at the press conference after a two-month-odd assessment.
"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
"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 the press conference.
The results mark the end of the first phase of the
clinical trials of the AIDS vaccine, which focused on the vaccine's 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 Oct. 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 the Guangxi CDC.
Some recipients' cells and body fluids in the
combined group appeared immune to the HIV-1 virus, said Sang Guowei.
"The HIV-1 specific cells injected into the
recipients were the DNA fragments of the virus which don't cause infection," he
A total of 344 blood samples were taken from the
volunteers with each one donating five to ten 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 effect, the Guangxi CDC announced on June
The volunteers were paid 2,000 yuan (250 U.S.
dollars) for their participation, which was set by the Chinese Medicine and
They signed an agreement with the Guangxi CDC for
getting the injection, which is responsible for future possible adverse
reactions from the vaccine, said one of the volunteers Peng Zhi.
"We were told the vaccine contains no live HIV virus
and we wouldn't be infected by getting the injection, and only partial
inflammation or pain might occur due to individual differences," said Peng, a
student from the Guangxi Medical University.
Half of the volunteers are from the university.
Others include government employees.
The scientists were analyzing the results of the
first phase and the SFDA would approve the second phase after a stringent
assessment, SFDA officials said.
"It is a breakthrough in China's AIDS vaccine
development, which was achieved by joint support from the central and local
governments, scientific researchers, the public and international partners,"
said Liu Yanhua, vice minister 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.
Before that, China had participated in several human
trials of AIDS vaccines, but they were all carried out in other countries.
The new vaccine must undergo three phases of clinical
trials before going into production. The second phase will assess both safety
and immunity nature of the vaccine while the third will target the protection it
offers for high-risk groups.
By the end of 2005, China had recorded more than
140,000 people infected with HIV. Officials estimate that China has
approximately650,000 people living with HIV, including approximately 75,000 AIDS
A group of scientists and experts have advised the
State Council, the Chinese cabinet, to raise funding for and encourage
innovation and cooperation in research, warning the disease is spreading quickly
to ordinary people.
According to the report disclosed at Friday's press
conference, there have been 120 AIDS vaccine tests on humans throughout the
world. The ongoing tests in China include 29 in phase I, four in phase I and II,
three in phase II and one in phase III.
The phase-III tests on the first-generation vaccine
failed, the report said.
China's research into AIDS vaccines has been going on
for 15 years but the country does not have the intellectual property rights over
its AIDS vaccines in trial and the research has limited global influence, the
The total infections of HIV in the world had exceeded
40 million and more than 30 million AIDS patients had died by the end of 2005,
according to figures released by the World Health Organization (WHO) and the
Joint United Nations Programme on HIV/AIDS (UNAIDS). Enditem