Study conducted by Meiji Seika Pharma in Japan
Data follow approval of the world's first Self-Amplifying messenger RNA (sa-mRNA) COVID-19 Vaccine for Adults by Japan Ministry of Health, Labor and Welfare
The randomized, double-blind, active-controlled study, conducted at 11 sites in Japan, was designed to compare the immunogenicity and tolerability of the sa-mRNA vaccine ARCT-154 with Comirnaty
Phase 3 Study published in The Lancet Infectious Diseases
KING OF PRUSSIA, Pa. & SAN DIEGO--(BUSINESS WIRE)--Dec. 21, 2023-- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain, and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty. ARCT-154 results were achieved with one sixth the dose of Comirnaty (5 μg vs 30 μg).
The study included healthy adults initially immunized with two doses of an mRNA vaccine (Comirnaty or Spikevax); and then a third dose of Comirnaty at least three months prior to the booster dose of either ARCT-154 or Comirnaty in the study. Both vaccines were well-tolerated, with no causally associated severe or serious adverse events. The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
"The initial head-to-head results of the ARCT-154 study are exciting as they show that our sa-mRNA vaccine platform has the potential to produce immunogenicity against COVID-19 in previously vaccinated patients that is as good or better—and at a much lower dose—than first generation mRNA vaccines," said Jonathan Edelman, M.D., Senior Vice President, Vaccines Innovation Unit, CSL. "These results move CSL one step closer to delivering on our promise to develop and provide differentiated innovations that help protect the public against the ongoing burden of COVID-19. We look forward to sharing additional data from CSL's sa-mRNA programs as we continue to advance this exciting technology."
"These important study findings mark another major achievement in the development of our innovative sa-mRNA vaccine platform and a significant moment for Arcturus and CSL," said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus Therapeutics. "This study represents the first phase of CSL and Arcturus' plans to launch this innovative vaccine platform globally."
The phase 3 study results with ARCT-154 were used to support the approval of ARCT-154 for primary immunization and as a booster dose in Japan in November of this year.
The ARCT-154 study is ongoing and will continue to collect safety data and assess durability of the immune response in participants at 3-, 6- and 12-months post-vaccination.