SINGAPORE — SingHealth is looking for 100 healthy adult volunteers to participate in the next phase of trials for a vaccine candidate that is being co-developed by the Duke-NUS Medical School and American pharmaceutical company Arcturus Therapeutics. To qualify, interested participants must be aged 21 and older and be fit and free from any serious illnesses.
Those who have chronic conditions such as high blood pressure or diabetes must have their conditions stabilised and well-controlled in order to volunteer for the trial, said SingHealth in a statement on Tuesday (Dec 29). The early-stage clinical trial for the Lunar-Cov19 vaccine began in August and concluded last month. Arcturus Therapeutics said in early November that it had found positive preliminary results. In its latest statement, SingHealth said that the interim study results showed robust antibody responses and balanced T-cell immune response to the vaccine.
This confirms the promising results seen in pre-clinical studies, it said, adding that the experimental vaccine in the early-stage trial was also "generally well-tolerated" by the healthy volunteers who had participated then. No volunteer withdrew from the study and there were "no related serious adverse events".
About 106 people were enrolled in the early-stage trials in Singapore. Twenty-eight of them received placebos, while the rest received either one or two doses. The Straits Times previously reported that the Economic Development Board (EDB) has pumped in US$45 million (S$61 million) into manufacturing the vaccine. The money will be used for the purchase of equipment, materials and services related to the vaccine's manufacture. EDB will also have the right to buy up to US$175 million worth of the vaccine at pre-negotiated prices, with shipments expected to begin in the first quarter of next year. SingHealth, which has an investigational medical unit conducting the trials in Singapore, said that this second phase of the trial will focus on the vaccine’s safety and ability to elicit a robust immune response.
At this stage, there are plans also to pick the optimal dose for a registrational third-phase study — the final stage of the clinical trials — which is planned for 2021.
For the second phase, SingHealth said that the vaccine doses and trial specifications are drawn up based on the immune responses and safety considerations observed in the earlier phase of the trial. "These have been reviewed by the regulatory and ethics bodies in Singapore, and are deemed safe to progress to the next phase of testing," it said.
Screening of volunteers for the second-phase trial will start in late December. There will be follow-ups with volunteers for about a year from recruitment to the end of the study.
Those who are interested in taking part in the Lunar-Cov19 vaccine trial may contact the SingHealth investigational medicine unit at firstname.lastname@example.org. They may also call 6323 7544 or 8318 0685.