Photo: Group Photo of the National Investigator Conference for Phase III Clinical Study of Recombinant Staphylococcus Aureus Vaccine
On the morning of March 12, 2023, the National Investigator Conference for Phase III Clinical Study of Recombinant Staphylococcus Aureus Vaccine was successfully held in Chongqing under the joint organization of Chengdu Olymvax Biopharmaceuticals Inc. (hereinafter referred to as “OLYMVAX”), the Army Medical University of the People's Liberation Army of China (“Army Medical University”) and Hangzhou Tigermed Consulting Co., Ltd. (“Tigermed”). Led by Professor Jiang Xieyuan of Beijing Jishuitan Hospital, this clinical study was involved in multi-center, randomized, double-blind, placebo-controlled clinical trials in Phase III to evaluate the protective efficacy, safety and immunogenicity of Recombinant Staphylococcus Aureus Vaccine (RSAV) in a target population of orthopedic surgery.
Opening speech was delivered respectively by Ling Jian, Vice District Mayor of Chongqing Shapingba District People's Government, Jiang Xieyuan, President of Beijing Jishuitan Hospital, Ye Xiaoping, President of Tigermed, Huang Chunji, Vice President of Army Medical University, and Fan Shaowen, Chairman of OLYMVAX. Fan Fan, Vice Chairman of OLYMVAX made an introduction to the Company.
Photo: Speeches by the Chairman and Vice Chairman of OLYMVAX
At the meeting, Professor Zou Quanming from the Army Medical University gave a detailed introduction to the research significance, background, technological transformation, achievements, international competitiveness and social influence of this vaccine, and then proposed an outlook on the research and development of polyvalent combined vaccine against severe nosocomial infection of drug-resistant bacteria. In this clinical project, the relevant person in charge of the CRO Tigermed reported and explained the clinical trial protocol, research progress and plan, and the concerns of the investigators. The investigators from Beijing Jishuitan Hospital, and the principal investigator organization provided clear instructions to all investigators participating in the Phase III clinical trial by combining the clinical experience of Phase II. Meanwhile, the director of the institutional office of the hospital also shared the cases on study quality risk management, so that the investigators could accurately grasp the key points and difficulties of the Project and give strong support for the completion of Phase III clinical trial with high quality.
In the discussion, all the participating investigators had in-depth discussions and exchanges. Three representatives from the sub-center shared their experience in clinical study enrollment, and summarized and analyzed the successes and failures after enrollment. The members of the Project Team expressed their confidence in the Project after the sharing and communication at this conference.
Photo: Conference Trivia
With strong mentality and steadfast faith, we seriously believe that we will achieve substantial achievements to fill the gap in the field of superbug vaccine as soon as possible with the joint efforts of all investigators.
Progress in Clinical Study on Recombinant Staphylococcus Aureus Vaccine.
Recombinant Staphylococcus Aureus Vaccine (RSAV) jointly developed by OLYMVAX and Army Medical University is a Class 1.1 original new drug in China. Since the approval of the clinical trial in 2015, this vaccine development project has taken 7 years to complete the Phase I and II human clinical trials in 11 centers with 666 subjects. The results show that the Recombinant Staphylococcus Aureus Vaccine has good vaccination safety and immunogenicity in the target population of 18-70 years old in China. The data from preclinical studies and Phase I clinical studies have been published in the international journal Vaccine in 2020.
The Phase III clinical study was officially launched in June 2022 and performed in more than 50 clinical study centers with 6,000 subjects.