LOCAL clinical trials will soon commence for two Covid-19 vaccines developed by a US-based company to target four variants of concern, including Delta.
The early-stage clinical trial, which has just received approval from the Health Sciences Authority, will evaluate the vaccines’ safety and immune response against the Alpha, Beta, Gamma and Delta variants, and as possible booster shots for vaccinated people.
The vaccines were developed by pharmaceutical firm Arcturus Therapeutics.
The trial is looking to recruit healthy male and female volunteers aged between 21 and 65. It will be administered by SingHealth’s Investigational Medicine Unit led by Assoc Prof Jenny Low.
Prof Low, the unit’s deputy clinical and scientific director, said: “The two new vaccines, ARCT-154 and ARCT-165 will be tested together with the original ARCT-021 vaccine, where we will compare all three vaccines against one another for their safety and antibody protection.”The ARCT-021 vaccine, which was previously known as the Lunar-Cov19 vaccine, is still undergoing phase two of its clinical trials, which began earlier this year.
It was co-developed by Duke-NUS and Arcturus Therapeutics, and targets the original or wild-type Sars-CoV-2 virus.
The ARCT-154 vaccine targets the D614G spike protein mutation that has become dominant globally, whereas the ARCT-165 vaccine targets a wider range of viral mutations, Prof Low noted.
A new variant can result from mutations at more than one part of the virus, although the majority of current circulating variants have the D614G mutation.
The trial is known here as the phase one/two trial. Phase one tests for the vaccines’ safety to ensure that there are no severe side effects.
A total of 72 participants will be recruited – 36 who have yet to be vaccinated and another 36 who received the second dose of their Pfizer jab at least six months ago.
Participants will be given any of the three vaccines, which will be administered in two doses, one month apart. Those who have been vaccinated will receive one dose of either vaccine, said Prof Low.
Once the safety of the vaccines have been ascertained, the trial will then move on to phase two, which will involve a larger cohort of volunteers with a focus on the participants’ immune response.
Phase three can then conclusively determine the vaccines’ efficacy against the four variants, she said. — The Straits Times/ANN