Vaccine maker Adimmune Corp (國光生技) yesterday said that it began the phase 1 trial of its COVID-19 vaccine this week.
The firm did not say when the first of an expected 70 participants was vaccinated and if there were any side effects.
It would reveal more information later, Adimmune said.
“Given that the novel coronavirus is mysterious, with some patients reportedly reinfected after being discharged, we would closely watch whether our candidate vaccine could induce an effective antibody against the virus and how long the antibody can remain protective,” Adimmune president Liu Chung-cheng (留忠正) told a media briefing in Taipei.
The company expects to enroll 70 volunteers by the middle of October with the help of National Taiwan University Hospital (NTUH), Liu said.
“Enrolling would take some time, as we are seeking volunteers who do not have chronic diseases, which is so determining a cause is not too difficult if side effects arise,” Adimmune spokesman Pan Fei (潘飛) said.
Adimmune, which previously planned to divide the 70 participants into three groups who would receive low, medium or high doses, would add one more group of participants to receive low doses combined with an adjuvant, which can boost the immune response of a vaccine, Pan said.
The plan is to apply to begin a phase 2 trial in early December, in which the candidate vaccine would be administered to 3,000 participants, Pan said.
The second-phase trial would include participants with other health issues to test the vaccine’s effect on such people, he said.
“Our goal is to enroll at least 1,500 participants for the phase 2 clinical trial, but the more the merrier,” Adimmune chairman Steve Chan (詹啟賢) said.
The company expects to end the phase 2 trial by Lunar New Year next year, which is in the middle of February, but it would continue monitoring participants for at least a year, Chan said.
As several companies and regulators in countries such as Brazil, Turkey, the Czech Republic, Singapore, Vietnam and the Philippines have expressed interest in cooperating with Adimmune on development of the vaccine, the firm would consider a multicenter, multinational phase 3 trial, Chan said.
Separately, TaiMed Biologics Inc (中裕新藥) on Tuesday signed a deal with Columbia University to gain access to a COVID-19 antibody developed by Aaron Diamond AIDS Research Center science director David Ho (何大一), a professor of medicine at the New York university who directed the work on the antibody, the firm said in a filing with the Taiwan Stock Exchange yesterday.
The antibody, among the nine that Ho’s team isolated from several patients severely infected with COVID-19, is expected to be a potent neutralizer of the novel coronavirus, TaiMed Biologics said.
The company would apply to the US Food and Drug Administration to conduct a phase 1 human test of the antibody in the spring of next year, TaiMed Biologics said.
It did not reveal the amount it paid to the university.
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