New COVID-19 sa-mRNA Results from CSL and Arcturus Therapeutics Demonstrate Longer Duration of Immunity Compared to Conventional COVID-19 mRNA Vaccine Booster
Study conducted by
- Short communication follows previously published data in The Lancet Infectious Diseases demonstrating Immunological Non-Inferiority to Wuhan Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster
- New data demonstrates continuous advantage of sa-mRNA over conventional mRNA vaccine in terms of duration of immune response
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These results follow approval of the world's first sa-mRNA COVID-19 vaccine for adults by
Japan Ministry of Health, Labor and Welfare inNovember 2023
The new analysis at 6 months post-vaccination shows that ARCT-154 induces a longer immune response as compared to Comirnaty for both the original
“These results further support sa-mRNA’s differentiating attribute to provide prolonged protection against COVID-19 at lower doses,” said
“This data, coupled with the initial Phase 3 results and approval in
ARCT-154 Six-Month Data Report
This randomized, double-blind, active-controlled study, conducted at 11 sites in
At baseline, participants in both groups had similar geometric mean titers (GMTs) surrogate virus neutralizing antibodies against Wuhan-Hu-1 strain (GMT ratio was 0.94 (95% CI 0.78-1.13)). One-month post-booster, the ARCT-154 group displayed a higher immune response with GMT of 5390 (95% CI 4899-5931, n = 378) compared to Comirnaty® group with GMT of 3738 (95% CI 3442-4060, n = 367), and a GMT ratio of 1.44 (95% CI 1.27–1.64).
Three months post-booster GMTs were 5928 (95% CI 5414–6491, n = 369) and 2899 (2648–3175, n = 356), with a higher GMT ratio of 2·04 (1·80–2·32). Day 91 titers were equal to or greater than Day 29 titers in 205 of 369 (55·6% [95% CI 50·3–60·7]) ARCT-154 recipients, but in only 108 of 356 (30·3% [25·6–35·4]) Comirnaty® recipients. Due to different rates of antibody waning, by Day 181 GMTs were 4119 (95% CI 3723–4557, n = 332) and 1861 (1667–2078, n= 313) in ARCT-154 and Comirnaty® groups, respectively, maintaining a GMT ratio of 2·21 (1·91–2·57) between vaccine groups. GMTs against Wuhan-Hu-1 remained numerically higher 180 days after ARCT-154 than those observed 28 days after the Comirnaty® booster.
The same pattern of superior immunogenicity and slower decline in Omicron BA.4/5 neutralizing antibodies was observed: GMTs were comparable at baseline (GMT ratio of 0.94 (95% CI 0.71-1.26), and increased to 2125 (95% CI 1841–2453) vs. 1624 (1418–1858) at Day 29 after ARCT-154 and Comirnaty®, then waned to 1892 (1646–2175) and 888 (764–1031), respectively, at Day 91. Between Days 29 and 91 titers were stable or increased in 128 of 369 (34·7% [95% CI 29·8–39·8]) ARCT-154 recipients, compared with 36 of 356 (10.1% [7·2–13·7]) in the Comirnaty® group. The difference in neutralizing activity against Omicron BA.4/5 was maintained to Day 181 when GMTs were 1119 (95% CI 960–1305) and 495 (413–595), with a GMT ratio of 2·26 (1·78–2·86) in favor of ARCT-154.
About sa-MRNA
mRNA vaccines help protect against infectious diseases by providing a blueprint for cells in the body to make a protein to help our immune systems recognize and fight the disease. Different from standard mRNA vaccines, self-amplifying mRNA vaccines instruct the body to make more mRNA and protein to boost the immune response.
About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses:
About
Founded in 2013 and based in
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Arcturus Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact included in this press release, are forward-looking statements, including those regarding plans to collect and share additional data and analyses and the potential of the sa-mRNA technology to provide advancements over conventional mRNA vaccines. You should not place undue reliance on such forward-looking statements. These statements are only current predictions or expectations, and are subject to known and unknown risks, uncertainties, and other factors, including those discussed under the heading "Risk Factors" in Arcturus’ most recent Annual Report on Form 10-K, and in subsequent filings with, or submissions to, the
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