The Vietnam Ministry of Health has granted approval to Arcturus Therapeutics for commencing the Phase IIIb portion of Phase I/II/III clinical trial assessing its Covid-19 vaccine, ARCT-154, against SARS-CoV-2 delta variant and other variants of concern.
The company has started dosing the subjects in the trial, which will enrol nearly 20,000 subjects.
They will be given either two doses of the vaccine administered at a gap of 28 days or a placebo.
The approval to progress to Phase IIIb trial comes after a review of positive safety data obtained from the initial 1,000 subjects who were part of the placebo-controlled, observer-blind Phase I/II/IIIa trial.
To date, the Phase I segment has concluded the priming vaccination series with two doses in 100 people, with 75 subjects being enrolled in the ARCT-154 group.
The Phase II and Phase IIa portions are underway, enrolling 300 and 600 subjects, respectively.
Arcturus Therapeutics president and CEO Joseph Payne said: “Initiation of dosing in the Phase IIIb portion of the study brings us one step closer to our goal of filing for EUA and making it available as quickly as possible.
“As a low dose vaccine targeting variants of concern, ARCT-154 has a differentiated profile compared to currently available vaccines and we believe that our programme has the potential to become a best-in-class option for Vietnam and many other countries around the world.”
The company, along with its manufacturing partner, Vinbiocare Biotechnology, plans to seek emergency use authorization (EUA) for the vaccine in Vietnam in December this year.
This August, Arcturus reported that Vinbiocare received approval from the Vietnam Ministry of Health to conduct Phase I/II/III trial of ARCT-154.
During the same month, Arcturus and Vinbiocare signed a collaboration agreement to build a manufacturing plant in Vietnam to produce the former’s experimental Covid-19 vaccines for supply and use in the country.