Duke-NUS' vaccine approved for clinical trials ahead of predicted date; first study to involve 108 volunteers

The first study will be done to evaluate dose levels.
The first study will be done to evaluate dose levels.PHOTO: REUTERS

SINGAPORE - A vaccine jointly developed by Duke-NUS Medical School and United States pharmaceutical company Arcturus Therapeutics has received approval for clinical trials.

This puts it among 24 other candidate vaccines around the world that are currently undergoing clinical evaluation.

Professor Ooi Eng Eong, deputy director of the school's emerging infectious diseases programme, had previously told The Straits Times that the vaccine trials had "exceeded expectations" and could potentially result in its human trials being brought forward from September to August.

But in a joint statement on Tuesday night (July 21), the two organisations said that Singapore's Health Sciences Authority had given them the approval to proceed, and that they would begin dosing humans with the vaccine, known as Lunar-Cov19, as soon as possible.

Prof Ooi said in Tuesday's statement that pre-clinical studies of the vaccine had shown "very promising findings", including the possibility that just a single dose of the vaccine might be sufficient to trigger a robust and durable immune response against the coronavirus.

He said: "We are very eager to start the first-in-human clinical trial here in Singapore and advance Lunar-Cov19 on its journey to becoming a potential commercial vaccine."

Lunar-Cov19 contains genetic material called mRNA, which encodes part of the virus. Injected into a person, it causes the body's cells to begin manufacturing a protein similar to that of the virus, allowing the body to recognise and learn to fight it.

The first study will involve 108 healthy adult volunteers of various ages, and will be done to evaluate dose levels.

A follow-up study will be conducted to evaluate the safety and tolerability of the vaccine, and the extent and duration of the body's immune responses.

 
 
 

President and chief executive of Arcturus Therapeutics Joseph Payne said: "We are excited to advance this promising vaccine candidate into clinical trials."

Professor Thomas M. Coffman, dean of Duke-NUS Medical School, said: "There is a tremendous global imperative to develop effective preventive measures for Covid-19 infections. We are heartened by the rapid and promising progress in our vaccine collaboration with Arcturus as we move forward into clinical trials."