- #Venture towns researching new registration#
- #Venture towns researching new trial#
- #Venture towns researching new series#
Global Phase 3 placebo-controlled onset prevention trial
Enrollment has been completed, so the vaccination has been completed. For more information about this clinical trial, please refer to jRCT No.: 2051210151.
#Venture towns researching new series#
This clinical trial is a double-blind randomized active controlled trial to evaluate a neutralizing antibody titer after the primary series of Vaxzevria or S-268019 in 1,000 adults and the elderly people. Neutralizing Antibody Comparative Clinical Trial
#Venture towns researching new registration#
Subject registration for this trial has been completed. For more information about this clinical trial, please refer to jRCT No.:2031210613. In this trial, the safety and immunogenicity of an additional dose of S-268019 aged 20 to 64 years who received 2 inoculation of Spikevax and elderly people aged 65 years or older who received 2 inoculation of a primary series of COMIRNATY. The top-line results of this trial were disclosed on March 4th. Subject registration for this trial and day 29 observations have been completed. For more information about this clinical trial, please refer to jRCT No.: 2031210470. In this trial, the efficacy and safety of an additional dose of Comirnaty or S-268019 in 200 adults, 6 months or more after receiving a primary series of Comirnaty, will be compared. This clinical trial is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of a primary series and booster doses of S-268019 in 350 adolescents who are 12 to 19 years old (S-268019 group: 300 subjects, COMIRNATY group: 50 subjects) will be assessed. The Phase 2/3 clinical trial in Japanese adolescent is randomized, active-controlled, double-blind, controlled trial.
Phase 2/3 clinical trial in Japanese adolescent The main purpose of this trial was to see the safety and the transition of neutralizing antibody titer, the preliminary results of this trial were announced at the 96th Annual Meeting of the Japanese Association for Infectious Diseases and Academic Lecture (held from April 22 to 23, 2022). After completing the second vaccination of all subjects and the day 57 observation. For more information about this clinical trial, please refer to jRCT No.:2031210383. The Phase 2/3 clinical trial is a open-label study to evaluate safety, tolerability and immunogenicity of s-268019 in 3,100 adults and elderly people. For more information about this clinical trial, please refer to jRCT No.: 2031210269. The Phase 1/2 clinical trial is double-blind and placebo-controlled study to evaluate safety, tolerability and immunogenicity of two doses of the vaccine. The table below summarizes the trials being conducted for the practical application of genetically modified protein vaccines. However, the recombinant protein vaccine is manufactured based on an established technology and several vaccines such as influenza prophylactic vaccine utilizing BEVS have been approved and put to practical use based on its efficacy and safety. Compared to novel technologies such as mRNA vaccines, by which the target antigen protein is synthesized in the body, the recombinant protein vaccine needs a certain development period for antigen expression and purification before initiating dosing trials.
The recombinant protein vaccine is administered by adding an adjuvant (a substance that enhances the effect of the vaccine) after expressing and purifying the target antigen protein from the genetic information of the virus. In collaboration with the National Institute of Infectious Diseases and Kyusyu University (the person who is in charge of this research has moved to Kyoto University), Shionogi is pursuing the discovery and development of a recombinant protein vaccine for COVID-19, using a unique technology, “BEVS*” of UMN Pharma Inc., a subsidiary of Shionogi.
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