On June 6, 2022, the Phase III Clinical Trial Kick-off Meeting of Recombinant Staphylococcus Aureus Vaccine (RSAV) (hereinafter referred to as “Staphylococcus Aureus Vaccine”), jointly developed by Chengdu Olymvax Biopharmaceuticals Inc. (OLYMVAX) and Army Medical University of the People's Liberation Army of China (“Army Medical University”) was successfully held in the form of online conference, despite the adverse impact of the epidemic.
More than 30 guests attended this kick-off meeting, including orthopedic research team of the Leading Organization - Beijing Jishuitan Hospital, the representatives of drug clinical trial institutions, representatives of the Central Laboratory - the First Medical Center of the People's Liberation Army, R&D team of Army Military Medical University, representatives of OLYMVAX and the CRO - Tigermed.
At the kick-off meeting, the Principal Investigator of the Leading Organization, President Jiang Xieyuan of Beijing Jishuitan Hospital, Director Wang Meixia of Clinical Trial Institution, Mr. Zou Quanming, a Chief Scientist of Staphylococcus Aureus Vaccine and Professor of Army Military Medical University, and leaders of OLYMVAX and Tigermed delivered speeches respectively, giving high expectations for this clinical trial.
President Jiang Xiyuan reviewed the Phase II clinical trials of Staphylococcus Aureus Vaccine. The results of Phase II clinical trials in orthopedic surgery patients who are susceptible to Staphylococcus aureus in the hospital proved the good safety and immunogenicity of this vaccine, providing a great encouraging effect on the development of phase III clinical trials. In addition, President Jiang stated that it was an honor to continue to be the leading organization for the Phase III clinical trials of the vaccine, which was of profound significance and significant responsibility.
Professor Zou Quanming from the Army Medical University stressed that “Each one have to make contributions to a more powerful China and more innovations”. He hoped that the internationally pioneered Phase III clinical trials of the 5-subunit Staphylococcus aureus vaccine would be completed successfully and that scientific and effective trial data and fruitful research results could be obtained.
At this kick-off meeting, the orthopedic research team of Beijing Jishuitan Hospital gave a systematic explanation and training on the overall design, trial process and precautions of clinical trials. The representatives of all parties had a thorough discussion and stated that they would do their own work to complete the Phase III clinical trials on time with high quality.
The Phase III clinical trials were intended to evaluate the protective efficacy, safety and immunogenicity of the Staphylococcus Aureus Vaccine in the target population of orthopedic surgery, and immunize against the severe infection and drug-resistant epidemic of Staphylococcus aureus from the source. It is of great practical and strategic significance to effectively control the widespread infection of Staphylococcus aureus, and significantly reduce the incidence rate of nosocomial infection of Staphylococcus aureus and the spread of drug resistance.