As learned from the SARS vaccine development research group the last six volunteers have accepted the inoculation of a clinical testing vaccine for severe acute respiratory syndrome (SARS) on August 4. By far all 36 volunteers in China's SARS vaccine first stage clinical research have been inoculated with the vaccine.
As learned from Lin Jiangtao, head of the Respiratory Medical Department with the China-Japan Friendship Hospital, after observing for a week the six volunteers are normal in temperature with no adverse reactions observed.
The SARS vaccine first stage clinical research adopts the randomized double-blind controlled trial method. A total of 36 volunteers aged between 21 and 40 were chosen with half male and half female, to participate in the clinical testing in groups. In order to achieve data necessary for assessing the safety of the vaccine observation will have to last 210 days.
On April 23 the first 4 volunteers accepted the SARS vaccine clinical research. By far 18 volunteers in the light-dose group have accepted two inoculations. Others in the heavy-dose group also have finished with the first injection and will begin to accept the second injection in turn.
According to an official in charge of the SARS vaccine development research group the clinical research has received the attention and support from various circles. Officials from the Ministry of Science and Technology (MST), the Ministry of Health and the State Food and Drug Administration (SFDA) paid visits to the research field and to the researchers and physicians. The public have exhibited great passion of participation. Among the 18 volunteers of the first group in the clinical research many volunteered to take part in it after discovering the news that the clinical research was about to start.
The official said the safety of the volunteers is guaranteed to the maximum extent. During the preparation stage of the clinical research the MST and SFDA organized several in-depth and detailed discussions on the clinical research solution and listened to the opinions and suggestions from relevant international organizations and overseas vaccine experts, so that the research solution could be more scientific and precise in design and more in line with international vaccine clinical research specifications. Before the clinical research started the researchers informed the volunteers of possible risks, their rights and details on protecting their privacy and obtained the informed approvals from the volunteers.
By People's Daily Online