China Begins Clinical Trials on a Home-made HIV/AIDS Vaccine

The first phase of clinical trials on China's second homemade HIV/AIDS vaccine began at Peking Union Medical College Hospital in Beijing last weekend.

The vaccine, jointly created by the National Center for Disease Control and Prevention and the National Vaccine & Serum Institute, will be tested on 36 volunteers, said Xinhua news agency, quoting Shao Yiming, chief professor of the project.

According to Shao, the vaccine marks a new approach to fighting the virus. The volunteers have been divided into two groups, one with smallpox vaccines and one without.

"We use the smallpox vaccine as the carrier of this new AIDS vaccine. We put the HIV virus gene into the smallpox vaccine and let it produce antibodies inside human bodies," Shao told the China Central TV (CCTV).

Different from other vaccines which have failed in previous tests, the new vaccine has a replicative vector, meaning it is designed to kill the HIV virus by replicating itself.

Early trials on mice and monkeys indicate the vaccine is safe and effective in stimulating the immunity of cells and body fluids.

"The results of the first-phase trial are expected to come out in about two months," Shao said.

In August, 2006, the country's first homemade AIDS vaccine, jointly created by Changchun Baike Pharmaceutical Company and Jilin University Vaccine Research Center, successfully passed the first phase of clinical trials.

Zhang Zhe, assistant manager of Baike, told Xinhua the vaccine had not entered the second phase of the trial yet but would not elaborate on when that was likely to happen.

There is still no effective HIV/AIDS vaccine in the world and two vaccines have failed after the third phase of clinical trials.

China's research into HIV/AIDS vaccines has been going on for 16 years but the country did not own intellectual property rights to its vaccines until 2006, according to a report released that year by the Chinese Academy of Sciences (CAS).

Wei Liang, an official with the State Food and Drug Administration, confirmed to Xinhua Tuesday that the two vaccines were both undergoing trials but declined to comment further.

The vaccine must undergo three phases of clinical trials before going into production. The first phase is focused on safety. The second phase will assess both safety and the immunity nature of the vaccine while the third will assess the protection it offers for high-risk groups.

Statistics from CAS show that up until August 2006, there have been 120 AIDS vaccine tests on humans throughout the world.

An estimated 700,000 people are believed to be infected with HIV/AIDS in China, according to new figures released by the government.

Source-Medindia
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