Medigen Vaccine Biologics Corp (高端疫苗) is to receive a subsidy of US$2.3 million from the international Coalition for Epidemic Preparedness Innovations (CEPI) to conduct a clinical trial in Taiwan to test its COVID-19 vaccine as a booster shot following full immunization with other brands, it said on Thursday.
The company plans to begin the trial once it is approved by the Food and Drug Administration, and aims to conduct an interim analysis by the end of March next year, it said.
The trial would be a “mix-and-match” type to test the safety and immunogenicity of different combinations of multiple brands of COVID-19 vaccines, Medigen said.
People who have received the first two shots of one brand — Moderna, AstraZeneca or Medigen — are to be randomly administered one of the three vaccines as the third shot in the human test, and the safety and immunogenicity among different groups are to be compared, it said.
Asked whether the clinical trial would focus on the vaccines’ protection against the Omicron variant of SARS-CoV-2, Medigen said that it would depend on whether the variant is found in Taiwan, company spokesman Leo Lee (李思賢) said.
As some parts of the world are experiencing a scarcity of COVID-19 vaccines, there is an increasing need to mix and match different brands, and data derived from this clinical trial could help countries devise flexible strategies for their vaccination programs, Medigen said.
The clinical results would be open to international organizations and regulators worldwide, the company added.
Medigen plans to recruit 960 participants and track them for six months, it said.
It is to conduct the trial at four medical centers: National Taiwan University Hospital, Taipei Veterans General Hospital, Taipei Municipal Wanfang Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital, it said.
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