Researchers and doctors are in the process of screening volunteers signing up for the vaccine, ensuring that they have the right site and health to be tested. The clinical trial phases are expected to last until October.
The SingHealth Medical Investigation Unit will conduct testing of this “candidate”. The new vaccine, called Lunar-Cov19, was developed by Duke-NUS School of Medicine and American pharmaceutical company Arcturus Therapeutics.
“More than 250 volunteers have confirmed participation in the trial. About 100 people between the ages of 20 and 50 will officially receive the shot next week. As the trial opens registration for volunteers between 21 and 80. age, so we hope to continue to have more participants, especially the elderly, “Associate Professor Jenny Low, deputy director of science and clinical at SingHealth told The Straits Times on July 7. 8.
Singapore’s nCoV vaccine clinical trial unit decided to run phases I and II at the same time to save time. Photo: Chong Jun Liang.
Ms. Jenny Low rated the response of people to registration to participate in the vaccine trial as “very encouraging”. These people, she said, are willing to contribute to the advancement of science, although the experiments are unlikely to benefit them.
Some traditional vaccines help keep people immune to pathogens by injecting a dead or weakened virus into their body. Since then, the body develops an immune mechanism and does not become infected when exposed to the virus. However, Singapore’s “candidate” vaccine was developed based on a new type of biotechnology, containing only fragments of genetic material instead of entire viruses.
When the viral genome enters human cells after an injection, they “command” the cell to begin producing the characteristic nCoV mutant protein. This trains the body to recognize an important part of the virus here is the mutant protein, from which antibodies are produced.
Prof Low said the vaccine “candidate” showed promising preclinical results. The next step is to perform tests to make sure it’s safe and able to generate strong antibodies, T-cell immunity in vaccinated people, providing long-term, anti-inflammatory protection. Covid- 19.
The first-stage clinical trial for the vaccine developed by Singapore is already underway. Typically, phase I clinical trials include only a small number of subjects, usually less than 100 people. They were recruited to evaluate the different dosages of the vaccine for potential toxicity. The body’s immune response will also be measured.
The focus of a phase II clinical trial is similar, except that the number of volunteers participating is usually increased to several hundred. Prof Low believes that the combination of phases I and II of this test will give more flexible results, helping to speed up the testing process without any gap in time after phase I.
Before allowing clinical trials, many measures have been taken to ensure the safety of the vaccine. This includes professionals conducting extensive pre-clinical trials, such as laboratory trials, animal studies, and safety testing.
Prof Low said the new vaccine could only transition into human clinical trials with promising preclinical results. Every phase of the trials is strictly supervised and managed by both the ethics committee and management.
Singapore’s nCoV vaccine is one of 26 “candidates” in the world that have been tested in humans or have received approval to conduct it. About 139 other “candidates” are still in the pre-clinical stage.
“As one of the ‘candidate’ in the world that has reached the clinical evaluation stage, this trial is certainly of great significance for Singapore. If the vaccine proves effective, Singapore will be in the position. is important in the global race to find a way to stop Covid-19, and hopes to help find a solution to the current pandemic, “said Jenny Low.
(The Strait Times)