 Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trialsNhân Thị Hồ,
Steven G. Hughes,
Ta Van Thanh,
Lân Trọng Phan,
Quyết Đỗ,
Thượng Vũ Nguyễn,
Anh Thị Văn Phạm,
Mai Thị Ngọc Đặng,
Lượng Viết Nguyễn,
Quang Vinh Trịnh,
Hùng Ngọc Phạm,
Mến Văn Chử,
Toàn Trọng Nguyễn,
Quang Chấn Lương,
Vy Thị Tường Lê,
Thắng Văn Nguyễn,
Lý-Thi-Lê Trần,
Anh Luu,
Anh Ngoc Nguyen,
Nhung-Thi-Hong Nguyen,
Hai-Son Vu,
Jonathan M. Edelman,
Suezanne Parker,
Brian Sullivan,
Sean Sullivan,
Qian Ruan,
Brenda Clemente,
Brian Luk,
Kelly Lindert,
Dina Berdieva,
Kat Murphy,
Rose Sekulovich,
Benjamin Greener,
Igor Smolenov,
Pad Chivukula,
Vân Thu Nguyễn and
Xuan-Hung Nguyen ()
Nature Communications, 2024, vol. 15, issue 1, 1-13 Abstract: Abstract Combination of waning immunity and lower effectiveness against new SARS-CoV-2 variants of approved COVID-19 vaccines necessitates new vaccines. We evaluated two doses, 28 days apart, of ARCT-154, a self-amplifying mRNA COVID-19 vaccine, compared with saline placebo in an integrated phase 1/2/3a/3b controlled, observer-blind trial in Vietnamese adults (ClinicalTrial.gov identifier: NCT05012943). Primary safety and reactogenicity outcomes were unsolicited adverse events (AE) 28 days after each dose, solicited local and systemic AE 7 days after each dose, and serious AEs throughout the study. Primary immunogenicity outcome was the immune response as neutralizing antibodies 28 days after the second dose. Efficacy against COVID-19 was assessed as primary and secondary outcomes in phase 3b. ARCT-154 was well tolerated with generally mild–moderate transient AEs. Four weeks after the second dose 94.1% (95% CI: 92.1–95.8) of vaccinees seroconverted for neutralizing antibodies, with a geometric mean-fold rise from baseline of 14.5 (95% CI: 13.6–15.5). Of 640 cases of confirmed COVID-19 eligible for efficacy analysis most were due to the Delta (B.1.617.2) variant. Efficacy of ARCT-154 was 56.6% (95% CI: 48.7– 63.3) against any COVID-19, and 95.3% (80.5–98.9) against severe COVID-19. ARCT-154 vaccination is well tolerated, immunogenic and efficacious, particularly against severe COVID-19 disease. Date: 2024 Downloads: (external link) Related works: Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-47905-1 Ordering information: This journal article can be ordered from DOI: 10.1038/s41467-024-47905-1 Access Statistics for this article Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie More articles in Nature Communications from Nature |
Is your work missing from RePEc? Here is how to contribute.
Questions or problems? Check the EconPapers FAQ or send mail to .
EconPapers is hosted by the
School of Business at Örebro University.