Arcturus Therapeutics has reported that its manufacturing partner, Vinbiocare, received approval from the Vietnam Ministry of Health to conduct Phase I/II/III clinical trial of its Covid-19 vaccine, ARCT-154.
ARCT-154 is a self-amplifying mRNA vaccine designed to act against SARS-CoV-2 variants of concern, including the Delta variant.
The randomised, observer-blind, placebo-controlled Phase I/II/III trial will analyse the safety, immunogenicity and efficacy of the vaccine in adults aged 18 years or above.
Funded by Vinbiocare, the trial will recruit up to 21,000 subjects across the three phases. The Phase III part will have 20,000 participants.
Subjects will be given two doses of the vaccine 28 days apart while those in the placebo arm will receive the active vaccine after six months. The participants will be followed up for a year.
Safety and efficacy are the primary goals and immunogenicity will be assessed in a subgroup.
On obtaining favourable data at interim analyses, Arcturus will seek emergency use approval from the Vietnam Ministry of Health this December.
Arcturus Therapeutics president and CEO Joseph Payne said: “We are very pleased to advance ARCT-154 into a significant, staged Phase III clinical development study with our partner to target SARS-CoV-2 variants of concern, including the Delta variant.
“ARCT-154 utilises Arcturus’ STARR mRNA technology, and our preclinical immunogenicity data demonstrates that our newly developed vaccine candidate elicits a strong neutralising antibody immune response against the Delta variant and other variants of concern.”
In January 2021, Arcturus Therapeutics announced plans to commence the Phase II clinical trial of its vaccine candidate, ARCT-021, for Covid-19 in the US.
Separately, the US Food and Drug Administration cleared Vaxart’s investigational new drug application to conduct a Phase II trial of an S-only oral tablet vaccine candidate for Covid-19.
The Phase II trial is scheduled to begin in the coming months.