Additional 14 volunteers healthy after first inoculation in Sinovac Biotech clinical trials of SARS vaccine
Sinovac Biotech Ltd (Sinovac) announced that the second subgroup of 14 volunteers in phase 1 clinical trials of its SARS vaccine received their first inoculation two weeks ago and results of recent blood testing has shown that there are no adverse reactions reported to date.
The inoculation process of the initial 4 volunteers as first reported on May 25th, 2004 has been completed. Those first 4 volunteers received their initial inoculation on May 22, 2004, and after no adverse side effects were observed, the volunteers received a second inoculation on 19 June 2004. Upon completion of the first 30-day observation period those recipients remain healthy, completing the vaccination schedule for the initial four volunteers.
The 18 noted volunteers are the first recipients to have received inoculations out of a group of 36 subjects currently participating with Sinovac in the first human clinical trials ever performed worldwide in the development of a SARS vaccine. The vaccination and observation of the remaining 18 volunteers of the Phase 1 clinical trials will be commenced in different subgroups shortly.
Upon completion, this first phase of clinical trials being performed by Sinovac will help determine if its SARS vaccine is a safe anti-viral antigen for the human body. During the phase I clinical trials, Sinovac will provide continuous updates on its status and report on the ongoing health condition of the volunteers.
Sinovac is the only company in China, and indeed the world, to have been approved to conduct human clinical trials of a SARS vaccine.
SARS (Severe Acute Respiratory Syndrome), a viral respiratory illness caused by a coronavirus, was first reported in Asia in February 2003, and over the following few months, the illness spread to more than two dozen countries in North America, South America, Europe, and Asia. According to the World Health Organization, during the SARS outbreak of 2003, a total of 8,098 people worldwide became sick with SARS; of these, 774 died.