Details

Autor(en) / Beteiligte

• Hồ, Nhân Thị
• Hughes, Steven G
• Ta, Van Thanh
• Phan, Lân Trọng
• Đỗ, Quyết
• Nguyễn, Thượng Vũ
• Phạm, Anh Thị Văn
• Thị Ngọc Đặng, Mai
• Nguyễn, Lượng Viết
• Trịnh, Quang Vinh
• Phạm, Hùng Ngọc
• Chử, Mến Văn
• Nguyễn, Toàn Trọng
• Lương, Quang Chấn
• Tường Lê, Vy Thị
• Nguyễn, Thắng Văn
• Trần, Lý-Thi-Lê
• Thi Van Luu, Anh
• Nguyen, Anh Ngoc
• Nguyen, Nhung-Thi-Hong
• Vu, Hai-Son
• Edelman, Jonathan M
• Parker, Suezanne
• Sullivan, Brian
• Sullivan, Sean
• Ruan, Qian
• Clemente, Brenda
• Luk, Brian
• Lindert, Kelly
• Berdieva, Dina
• Murphy, Kat
• Sekulovich, Rose
• Greener, Benjamin
• Smolenov, Igor
• Chivukula, Pad
• Nguyễn, Vân Thu
• Nguyen, Xuan-Hung

Titel

Safety, immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine: pooled phase 1, 2, 3a and 3b randomized, controlled trials

Ist Teil von

• Nature communications, 2024-05, Vol.15 (1), p.4081-13, Article 4081

Ort / Verlag

England: Nature Publishing Group

Erscheinungsjahr

2024

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.