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Phase I human clinical testing of SARS vaccine update offered.
2004 OCT 6 - (NewsRx.com & NewsRx.net) -- Sinovac Biotech Ltd. (Sinovac) (OTCBB:SNVBF) announced that all 36 subjects of the phase I human clinical trial for its inactivated SARS vaccine have now been vaccinated with two doses of either SARS vaccine or placebo.
The immunization schedule for the trial is now complete.
The final 6 subjects in the second group of 18 volunteers received their second vaccination on the 1st September 2004. No adverse side effects were observed during the 72-hour observation period after this second inoculation. Blood sampling from these final six subjects has been completed. The second group of 18 volunteers has been injected with either the high-dosage (32 su/mL antigen) SARS vaccine or a placebo. Each sub-group of six volunteers received their second inoculation 28 days after the first inoculation dates as noted below.
According to Professor Lin Jiangtao, head of the Respiratory Medical Department with the China-Japan Friendship Hospital in Beijing, who chairs the trial, the first group of 18 people who have been inoculated with low-dosage (16 su/mL antigen) SARS vaccine and the second group of 18 who have been inoculated with high-dosage (32 su/mL antigen) vaccine have not experienced any adverse reaction and are all in good health condition.
The first phase of human testing will determine if the vaccine is safe for the human body. During the phase I clinical trial, Sinovac will provide continuous updates on the status of the trial and the health condition of the volunteers. The ultimate aim of the vaccine will be to provoke the body's immune system into action, so that it can destroy the SARS virus if infected.
Also, and of particular note, antibody levels induced by the vaccine are being tested for the duration of the phase I clinical trial. The ability of these antibodies to prevent infection from SARS will not be tested in this trial.
Sinovac is the only company in China, and indeed the world, to have been approved to conduct human clinical trials of a SARS vaccine.
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